Psychology Blog

In fact, about half of the children in the study who were found to have Attention-Deficit/Hyperactivity Disorder before tonsil surgery no longer met criteria for this diagnosis one year later. Other cognitive and behavioral issues also improved.

On the whole, the 78 children who had their tonsils out were much more likely than a comparison group of 27 children to have had behavior and sleep problems at the start of the study. But by the end of the study, tests showed little difference between the two groups.

The research paper is published online in the April issue of the journal Pediatrics by a team from the University of Michigan Health System. Data were collected from rigorous tests of sleep and breathing at night, and attention and behavior during the day. The results support previous observations of a link between children’s sleep-related breathing problems — such as snoring and breathing interruptions called apneas — and daytime behavior problems.

The researchers caution that their results do not yet prove cause and effect, and that tonsillectomy is not usually a “cure” for ADHD. But, they say, the growing body of evidence on this issue suggests that a significant number of children with inattention, hyperactivity, or sleepiness during the day – and also sleep-breathing problems at night – may benefit during both the night and day by tonsillectomy, an operation that was once performed on more than a million children a year but has become much less common in recent decades.

The procedure, also called adenotonsillectomy when both the tonsils and structures called adenoids are removed, is now performed on a few hundred thousand children a year. Nearly half of them have the surgery because enlarged tonsils and adenoids block the flow of air through their throat and impair their ability to breathe, and most of the rest because of repeated ear and throat infections. Almost all of the children who had surgery in the new study were thought by their surgeons to have symptoms of sleep apnea.

“These findings help support the idea that sleep-disordered breathing is actually helping to cause behavioral problems in children, and making them sleepy,” says lead author Ronald Chervin, M.D., M.S., director of the U-M Sleep Disorders Center and co-leader of the U-M Center for Sleep Science. “This is one of the first studies to document, using gold-standard measures, that all of these sleep and behavior problems tend to resolve one year after enlarged tonsils and adenoids are removed.”

One of the most striking findings – that children once diagnosed with ADHD no longer had the condition a year after tonsillectomy – occurred in 11 of 22 children with ADHD. This means that sleep and breathing problems are only part of the ADHD puzzle, and that tonsillectomy isn’t a cure-all for ADHD, notes Chervin, an associate professor of neurology at the U-M Medical School.

A few children even developed new ADHD a year after surgery. Chervin says this supports previous evidence that damage from sleep-disordered breathing may occur in early years, even though the result is not seen until later. If confirmed, this would mean that early diagnosis and treatment of sleep-disordered breathing are particularly important.

When they entered the study, and before any surgery, all the children in the study had their behavior assessed by a child psychiatrist, as well as by their parents, who completed standardized questionnaires. The children had their attention span and short-term memory measured using a standard computer-based test, and spent a night in the U-M Michael S. Aldrich Sleep Disorders Laboratory. There, they were monitored for breathing problems during sleep, and also for their level of sleepiness, as measured by how long it took them to fall asleep in a series of naps.

All the tests were repeated a year after the children had a tonsillectomy at U-M C.S. Mott Children’s Hospital or St. Joseph Mercy Health System, performed by otolaryngologists (ear, nose and throat doctors) from any of eight practices in the local area. For the comparison group, who had non-tonsil surgery or no surgery, the second round of testing was performed a year after initial tests. The researchers analyzed the test results using sophisticated statistical analysis.

Among those children scheduled for tonsillectomy, the sleep-breathing tests showed that before surgery, half of them had obstructive sleep apnea (OSA), usually in the mild to moderate range, in contrast to only one of the comparison children. At the end of the study, only 12 percent of the tonsillectomy patients had OSA, including one patient who hadn’t had it before tonsillectomy, compared with 3 children among the comparison patients who completed the sleep test series. In all, five children did not complete follow-up tests.

In people of any age, OSA occurs when breathing stops and starts repeatedly during the night, often in part because the throat is narrowed or blocked, keeping sufficient air from getting into the windpipe and lungs. People with sleep apnea often snore, or snort and gasp throughout the night, though not all snorers have sleep apnea. About one to three percent of children have OSA, including a good number of those children who snore regularly. Enlarged tonsils are a common cause of the sleep disorder in children, while obesity, allergies, acid reflux and structural abnormalities in the head and neck also contribute to it in children and adults.

Interruptions in breathing during sleep can cause the brain to “wake up” to some extent, even if the sleeping person is not aware of it. These repeated interruptions disturb the sleep patterns that are essential to a good night’s sleep – and are thought to be the reason why daytime behavior might be affected by poor breathing during the night. Sleep apnea is also linked to heart and blood pressure problems, and in children, to slow growth.

The researchers also compared the tonsillectomy patients who had had OSA before surgery with those who had not. In all, the children who had not had it before tonsillectomy were just as likely as the children with OSA to have a high score on standard tests of hyperactivity, and just as likely to have behavioral improvement after tonsillectomy.

As a result of this finding and other data, the study adds to an issue that’s currently puzzling sleep researchers: Why the results of sleep tests to monitor brain activity and breathing don’t always correlate with children’s daytime behavior. The standard measures used to assess children’s sleep problems, and the threshold levels that are used to assess the severity of a sleep problem, may need to be reevaluated, says Chervin.

To explore this issue further, he and his U-M colleagues are now recruiting patients for a study that will compare those standard measures with new ones, including a measure of how hard children work to breathe during the night, and another that looks for subtle changes in brain activity with every labored breathing cycle.

The bottom line for parents, Chervin and his colleagues say, is that any child who snores regularly, or has other signs of breathing problems during sleep, may benefit from an evaluation for sleep problems and perhaps from tonsillectomy – especially if the child is also having behavior problems at home or school.

“If you have a child who has difficulties with attention deficit, hyperactivity, or daytime sleepiness, there may be something that can be done about it if the child proves to have a sleep disorder,” Chervin says. “An undiagnosed sleep disorder is not the solution for all children with ADHD. But it could be something worth looking into for a substantial minority, especially those children with symptoms that suggest a sleep disorder such as sleep apnea.”

In addition to Chervin, the study’s authors are Deborah Ruzicka, R.N., Ph.D., of the Sleep Disorders Center; Bruno Giordani, Ph.D., Elise Hodges, Ph.D., and James Dillon, M.D., of the U-M Department of Psychiatry; Robert Weatherly, M.D., formerly of the U-M Department of Otolaryngology and now at the University of Kansas; Carole Marcus, MBBCh, of the Sleep Center at the Children’s Hospital of Philadelphia; and Kenneth Guire, M.S., of the U-M School of Public Health.

###

For more on the U-M Sleep Disorders Center, visit med.umich.edu/neuro/sleeplab. The new study involving children scheduled for tonsillectomy is recruiting only patients whose surgery will be performed at C.S. Mott Children’s Hospital or St. Joseph Mercy Ann Arbor hospital; more information on the study and contact information for prospective participants is available via the U-M Engage clinical research web site, med.umich.edu/engage, or by calling 800-742-2300 and entering 6512.

The study was funded by the National Institute of Child Health and Development, the National Heart Lung and Blood Institute, the National Institute for Neurological Disorders and Stroke, and the U-M General Clinical Research Center.

Kara Gavin
kegavinumich.edu
University of Michigan Health System

More than 50 per cent of feverish children are given incorrect doses of medicine by parents and overdoses have almost trebled in the last two decades, according to a research review in the latest Journal of Advanced Nursing.

Health professionals are also concerned about the increasing number of parents who give their children alternate doses of paracetamol and ibuprofen without leaving sufficient gaps between them.

“Our review found that overdosing with ibuprofen is now a particular concern, both in terms of dosage and frequency” says nurse researcher Anne Walsh from Queensland University of Technology in Australia.

“We also discovered that some parents are giving their children one fever-reducing drug and then trying another type within a few hours if the first one doesn’t have the desired result.”

The Australian research team reviewed more than 70 studies published worldwide since 1980 to see how parental attitudes and practices had changed when it came to treating common childhood fevers.

They found that:

* Latest figures show that the number of parents providing their children with overdoses has risen from 12 per cent in 1987 to 33 per cent. Meanwhile, correct doses have risen from a third to between 43 and 49 per cent.

* Many parents administer fever-reducing drugs in doses that are too low, too high or too frequent.

* Underdosing is more common in younger and low-weight children.

* Up to 27 per cent of parents alternate fever reducing drugs.

The researchers also discovered that parents consistently treat childhood fevers based on inaccurate temperature readings and suggest that they would be better off focussing on their child’s general well-being rather than just how hot they are.

“Parents knowledge about normal body temperature and what constitutes a feverish temperature is poor” adds Anne Walsh, from the University’s Institute of Health and Biomedical Innovation.

“They classify mild fever as high and actively reduce temperatures, sometime normal temperatures, with fever-reducing drugs such as paracetamol and ibuprofen.

“Overdoses have sharply increased over the last 20 years and recent studies have suggested that parents are giving children higher than recommended doses in about a third of cases.

“Other parents underdose their children and, when their temperature hasn’t reduced to a level they consider satisfactory, they seek professional assistance, placing burdens on already strained healthcare systems.”

Other key findings included:

* Today’s parents have similar worries to their 1980′s counterparts – including brain damage, febrile convulsions and death – regardless of how well educated they are or their socio-economic status. Attitudes to fever seem to be similar in all countries.

* The use of cold or iced water and aspirin to lower fever has reduced, especially after research showed links between Reye syndrome, a potentially fatal disease, and aspirin. But parents have increased their use of other fever-reducing drugs and often wake sleeping children to sponge them or give them medicine.

* Education programmes run for parents in various countries have helped them to handle fever more effectively and reduced unnecessary use of healthcare services.

“Caring for a feverish child is emotionally challenging for parents and the limited improvements in knowledge, attitudes and practices highlighted by our research point to the need for a closer examination of the subject” says Anne Walsh.

“It is also very important that parents receive advice and guidance from healthcare professionals before their child experiences his or her first feverish episode.

“Fever management education needs to highlight the benefits of mild fever and equip parents with the knowledge and skills they need to manage mild to moderate fevers.”

However the authors stress that although effective parental education will improve knowledge and reduce unnecessary concerns, parents shouldn’t hesitate to ask for professional advice if they are worried about a child’s fever.

###

Notes to editors

Management of childhood fever by parents: literature review. Ann Walsh and Helen Edwards, Institute of Health and Biomedical Innovation, Queensland University of Technology, Australia. Journal of Advanced Nursing. Volume 54.2, pages 217 to 227.

Journal of Advanced Nursing, which is celebrating its 30th anniversary in 2006, is read by experienced nurses, midwives, health visitors and advanced nursing students in over 80 countries. It informs, educates, explores, debates and challenges the foundations of nursing health care knowledge and practice worldwide. Edited by Professor Alison Tierney, it is published 24 times a year by Blackwell Publishing Ltd, part of the international Blackwell Publishing group. journalofadvancednursing/

Contact: Annette Whibley
wordwizardclara
Blackwell Publishing Ltd.

A new study on children undergoing liver transplants found that although innovative transplant techniques have been developed in recent years, the waiting list times for pediatric transplant candidates have increased compared to the early 1990s. In addition, although waiting list deaths have decreased for children overall, they have remained essentially the same for infants.

The results of this study appear in the April 2006 issue of Liver Transplantation, the official journal of the American Association for the Study of Liver Diseases (AASLD) and the International Liver Transplantation Society (ILTS). The journal is published on behalf of the societies by John Wiley & Sons, Inc. and is available online via Wiley InterScience at interscience.wiley/journal/livertransplantation.

Beginning with the first successful liver transplant in 1967, pediatric transplantation has played a major role in developing new techniques for successful liver transplants. Following the introduction of the immunosuppressant cyclosporine in 1980, multiple transplant centers were established worldwide in the 1980s and long-term survival has continued to increase since then. However, due to the nature of childhood liver disease, infants and toddlers are more commonly transplant candidates than older children, and a shortage of appropriate sized livers has translated into a mortality rate as high as 40 percent for young patients awaiting transplant. Splitting one liver into two smaller grafts, utilizing techniques for reducing an adult-sized liver, developing living donor transplants, and employing novel microsurgery techniques are the latest options available to pediatric patients. The current study compared the profile of these patients in the early 1990s to more recent liver transplant patients.

Led by Sandy Feng, M.D., Ph.D., of the Department of Surgery at the University of California San Francisco, researchers compared 1,472 pediatric patients who underwent liver transplants between January 1990 and December 1992 to 1,420 patients who had transplants between March 2002 and December 2004. They found that more children between 11 and 17 years old and fewer children 1 to 5 years old received transplants in the later period. In addition, while biliary atresia (a congenital absence of the bile ducts) remained the most common indication for a transplant, it accounted for almost half of the transplants in the earlier period compared to about one third in the later period, while there was an increase in tumors as an indication for transplant. The number of pediatric patients on the waitlist increased only slightly in more recent years, but the average waiting time for a transplant increased significantly. These changes in waitlist characteristics and times for pediatric candidates were juxtaposed against those for adult candidates which have also increased even more dramatically.

“As expected, based upon our premises in selecting two eras of pediatric liver transplantation for comparison, there was a major shift towards the use of technically demanding grafts particularly to achieve transplantation of the youngest candidates, the infants and toddlers,” the authors note. They add that while children now account for only 6 percent of the waiting list compared to 15 percent a decade earlier, waiting times have increased and it is the youngest patients who continue to suffer more disease and death due to insufficient organ supply. The authors conclude: “We hope that our observations motivate studies and initiatives which aim to improve access and outcomes for young children, particularly infants, in need of liver transplantation.”

In an accompanying editorial in the same issue, Benjamin Shneider and Sukru Emre of the Mount Sinai Medical Center in New York note that infants with liver disease represent a distinct challenge, from both a surgical and medical perspective. Newborns tend to have either neonatal liver failure or true acute liver failure that develops immediately after birth. “Supportive care for these children is technically very difficult due to their small size and it is not surprising that these children have a high waitlist mortality,” they state. In recent years, improved post-transplant survival has resulted in expanding indications for liver transplants in children. However, the authors advise caution regarding this practice, noting that pediatric transplants are often tied into adult programs, despite the fact the overall numbers of transplants in children have remained unchanged. “Typically, it is not economical to maintain programs that have low annual volume and as such there will be pressure to increase volume at all of these programs,” the authors note, adding that this presents a potential conflict of interest to those providing care. Finally, one of the biggest challenges in pediatric liver transplants lies in the fact that the number of adult transplants has increased significantly in recent years, and children and adults potentially compete for the same organs. Noting that this problem may become critical, the authors conclude: “Split rather than reduced-size liver transplantation should be strongly encouraged as it allows children and adults to share rather than compete for livers from adult donors.”

###

Article: “Trends Over a Decade of Pediatric Liver Transplantation in the United States,” Sandy Feng, Ming Si, Sarah E. Taranto, Maureen A. McBride, Christine Mudge, Susan Stritzel, John P. Roberts, Philip Rosenthal, Liver Transplantation; April 2006 (DOI: 10.1002/lt.20650).

Editorial: “Pediatric Liver Transplantation: Past, Present, and Future,” Benjamin Shneider, Sukru Emre, Liver Transplantation; April 2006 (DOI: 10.1002/lt.20669).

David Greenberg
dgreenbewiley
John Wiley & Sons, Inc.

The FDA has approved the Daytrana patch, a skin patch for the treatment of ADHD (Attention Deficit Hyperactivity Disorder) in children. Regulators said the patch would help in the administration of ADHD drugs to children who find it hard to take pills or tablets. According to many experts, a large number of children taking ADHD medication have problems with swallowing pills.

The Daytrana Patch is a once-daily treatment for children 6-12. It should be placed on the skin (hip) early in the morning and removed nine hours later. The patch should be applied, alternately, on the left and right sides of the hip (e.g. Monday – left, Tuesday – right, etc.) The patch comes in four strengths.

The Daytrana patch is made by Shire Pharmaceuticals Group Plc (UK) and Noven Pharmaceuticals Inc (USA). The Daytrana Patch delivers the active ingredient of Ritalin (methylphenidate) via the skin. Ritalin is currently the most popular ADHD drug in the USA.

Label warnings will be the same as for other ADHD drugs concerning children who have existing heart conditions. Many would like to see more warnings on ADHD drugs. The Daytrana Patch will also carry warnings related to skin sensitivity – redness and bumps. Other possible side-effects include insomnia, weight loss, nausea/vomiting and anorexia.

The FDA stressed that the Daytrana Patch should be used as part of a comprehensive treatment program for ADHD, including educational and social elements.

View drug information on Ritalin LA.

Onset Therapeutics, a specialty pharmaceutical company that focuses on the development and commercialization of innovative treatments for skin and skin related disorders, announced the launch of Anestafoam™, a novel topical foam formulation containing lidocaine 4%. Anestafoam™ is the first and only foam formulation of lidocaine on the market. It incorporates the Company’s proprietary Delevo™ Foam Technology and is indicated for the temporary relief of pain associated with minor cuts and scrapes, abrasions, skin irritation, sunburn, burns and insect bites. The Company intends to sell the product primarily to dermatologists and podiatrists through its national field sales force. Anestafoam™ will also be available at retail drug stores and through internet distribution channels.

It is widely accepted by practicing dermatologists that the characteristics and type of product delivery vehicle are extremely important when determining the efficacy, side effect profile and patient compliance of topical products. Conventional topical vehicles such as creams, lotions and ointments can have attributes that reduce patient compliance and compromise efficacy. The Delevo™ Foam Technology incorporates active ingredients in a foam vehicle that utilizes a semi-solid emollient micro-emulsion system to deliver the active ingredient rapidly and efficiently. Failure to efficiently release the active(s) from topical formulations can delay the onset of activity and thus reduce the effectiveness of the product. In addition, the Delevo™ foam is moisturizing, alcohol-free, easy to spread over large areas of the body, and leaves no messy residue after absorption into the skin. All of these attributes can lead to higher patient acceptability ratings and patient compliance.

Data presented by the Company at the 66th Annual Meeting of the American Academy of Dermatology in San Antonio, TX on February 1-5, 2008 demonstrated that the release profile of lidocaine from Anestafoam™ was consistent with that required for the rapid onset of topical anesthesia. An in vitro study comparing rates of active release of lidocaine from Anestafoam™ and a commercially available lidocaine cream demonstrated that after application, Anestafoam™ released lidocaine at a faster and greater rate than did a commercially available cream formulationВ№.

Michael Heffernan, President of Onset Therapeutics commented, “Our innovative Delevo™ Foam Technology enables us to optimize the formulation of Anestafoam™ and introduce the first and only foam formulation of lidocaine on the market. We expect this product to provide clinicians and patients with significant advantages over currently available topical anesthetics on the market. We have a number of additional products in our pipeline that utilize our Delevo™ Foam Technology that we intend to launch over the next couple of years”.

About Onset Therapeutics

Onset Therapeutics, a wholly owned subsidiary of Collegium Pharmaceutical (collegiumpharma), is a specialty pharmaceutical company focusing on the development, manufacturing and commercialization of novel, patent protected topical products for the treatment of skin and skin related disorders. The Company’s currently marketed products include: Kerafoam®, Clarifoam™ EF, Optase® and Paptase®. In addition, Onset has an extensive pipeline of products in development utilizing its proprietary DELEVO™ foam technology. For more information, please visit the company’s website at onsettx.

Reference

1. Trumbore MW. A Comparison of the Rate and Extent of Lidocaine Release from a Novel Topical Anesthetic Foam vs. a Currently Marketed Lidocaine 4% Cream. AAD Meeting February 2008.

Onset Therapeutics

Centocor, Inc. announced today that the supplemental Biologics License Application (sBLA) for REMICADE® (R) (infliximab) for the treatment of pediatric Crohn’s disease has been accepted and designated for Priority Review by the U.S. Food and Drug Administration (FDA). Centocor is seeking approval for the treatment of moderately to severely active pediatric Crohn’s disease in patients who have had an inadequate response to conventional therapies. Currently, there are no approved biologic therapies for the treatment of pediatric Crohn’s disease, a chronic, potentially debilitating condition that causes inflammation of the gastrointestinal tract, typically resulting in symptoms such as diarrhea, fever, abdominal pain and weight loss. Children with Crohn’s disease may also experience delayed development and stunted growth. Orphan drug designation was granted by the FDA to REMICADE® for the treatment of pediatric Crohn’s disease on November 12, 2003. In addition, on August 30, 2004 a REMICADE® Phase 3 clinical development program for pediatric Crohn’s disease was designated Fast Track by the FDA.

The filing is based primarily on Phase 3 study results showing the unprecedented efficacy of REMICADE® in the treatment of children with moderately to severely active Crohn’s disease. In the REACH (a Randomized, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Anti-TNF Monoclonal Antibody REMICADE® in Pediatric Subjects with Moderate to Severe Crohn’s Disease) trial, nearly 90 percent (88.4 percent) of pediatric patients with moderately to severely active Crohn’s disease who had an inadequate response to conventional therapy achieved clinical response at week 10 when treated with REMICADE®. Nearly two-thirds (63.5 percent) of the patients who were randomized to treatment with REMICADE® every 8 weeks were in clinical response at one year. Additionally, more than half of the patients treated with REMICADE® every 8 weeks were in clinical remission at the end of one year.

“We are extremely pleased by the results of the REACH trial and by the FDA’s decision to accept the application with a Priority Review,” said Jerome A. Boscia, MD, Senior Vice President, Clinical Research and Development, Centocor, Inc. “REMICADE®, if approved for the treatment of pediatric Crohn’s disease, would represent a major advancement for children with this serious condition. We look forward to working closely with the FDA as it reviews these data for approval.”

Priority Review is granted by the FDA to products that are considered to be a potential therapeutic advance over current therapies. Acceptance of the sBLA filing does not mean that a license has been issued for this indication nor does it represent any evaluation of the adequacy of the data submitted in the sBLA. REMICADE® was FDA-approved in 1998 as the first biologic treatment for adults with moderate to severe Crohn’s disease. In September 2005, REMICADE® also became the first approved biologic treatment for moderate to severe ulcerative colitis (UC), making it the only biologic indicated for the treatment of both types of inflammatory bowel disease (IBD) in adults.

###

About REACH
REACH was a randomized, multicenter, open-label study designed to evaluate the safety and efficacy of REMICADE® in pediatric patients with moderate to severe Crohn’s disease. Patients (n=112) aged 6 to 17 years with moderately to severely active Crohn’s disease, despite treatment with an immunomodulator +/- corticosteroids, received REMICADE® 5 mg/kg at weeks 0, 2 and 6. One hundred three patients were randomized at week 10 to receive REMICADE® every 8 weeks (n=52) or every 12 weeks (n=51) through week 46. Ninety-nine of the 112 patients were in clinical response at week 10. Patients who lost response in the maintenance phase were eligible for a higher or more frequent dose of REMICADE®. Baseline demographic and disease characteristics were similar between groups. The median patient age was 13 years.

Data from the REACH trial showed that 88 percent of patients treated with REMICADE® 5 mg/kg at 0, 2 and 6 weeks achieved the primary end point of the trial, clinical response at week 10, which was defined as a decrease from baseline of at least 15 points in the Pediatric Crohn’s Disease Activity Index (PCDAI), and a PCDAI less than or equal to 30. Significantly more patients randomized to the REMICADE® maintenance regimen of one infusion every 8 weeks demonstrated clinical response and clinical remission at week 54 than those receiving REMICADE® maintenance every 12 weeks, a comparison made to better understand the pediatric dosing regimen. Sixty-three percent of patients (33 of 52) receiving REMICADE® every 8 weeks maintained clinical response after one year of treatment compared with 33 percent of patients (17 of 51) receiving maintenance therapy every 12 weeks (P = 0.002). At 54 weeks, 56 percent of patients (29 of 52) receiving REMICADE® maintenance every 8 weeks were in clinical remission as assessed by a PCDAI score of less than or equal to 10, compared with 24 percent (12 of 51) in the every 12-week maintenance group (P < 0.001).

Additionally, some patients in the trial were able to reduce their corticosteroid dose. At baseline, the median average daily corticosteroid dose of randomized patients who were receiving corticosteroids was 0.4 mg/kg/day. By their first maintenance visit (week 14 for the every 8 week group and week 18 for the every 12 week group), at least half of the patients had discontinued corticosteroids, an important step for many with Crohn’s who experience side effects as a result of corticosteroid use. The median changes from baseline in average daily corticosteroid dose at weeks 10, 30 and 54 were -0.2, -0.3 and -0.3 mg/kg/day, respectively. The change from baseline in average daily corticosteroid dose was significant (P < 0.001 for all comparisons).

In the REACH trial, patients were closely monitored, and the proportion of patients who experienced adverse events (AEs), serious adverse events (SAEs), serious infections, infusion reactions and immune responses were similar between the 8-week and 12-week REMICADE® maintenance groups. Through the entire clinical trial, the most common SAEs were related to Crohn’s disease. Infections were reported more frequently for subjects who received infusions every 8 weeks as opposed to every 12 weeks (73.6 percent and 38.0 percent, respectively), while serious infections were reported for 3 patients in the every 8 week and 4 patients in the every 12 week maintenance treatment group. As reported by investigators, infections were primarily upper respiratory infections, such as the common cold and bronchitis. Three patients developed antibodies to infliximab, and nine patients in each maintenance group experienced an infusion reaction; there were no serious infusion reactions. No deaths, malignancies, reactivation of latent tuberculosis, neurological disorders or autoimmune disorders were noted. Overall, the AEs were consistent with those seen in previous trials in adult patients. Please see Important Safety Information below. REMICADE® has not been studied in patients with pediatric Crohn’s disease six years of age or younger.

About Pediatric Crohn’s Disease
Crohn’s disease is a chronic illness that causes inflammation of the gastrointestinal tract, typically resulting in symptoms such as diarrhea, fever, abdominal pain and weight loss. Children with Crohn’s disease may also experience delayed development and stunted growth. Although it can involve any area of the gastrointestinal tract from the mouth to the anus, it most commonly affects the small intestine and/or colon.

About REMICADE®
REMICADE® is the global market leader among anti-tumor necrosis factor alpha (TNF-alpha) therapies and has demonstrated broad clinical utility in rheumatoid arthritis (RA), Crohn’s disease (CD), psoriatic arthritis (PsA), ulcerative colitis (UC), and ankylosing spondylitis (AS). The safety and efficacy of REMICADE® have been well established in clinical trials over the past 13 years and through commercial experience with more than 700,000 patients treated worldwide.

In the U.S., REMICADE®, in combination with methotrexate, is indicated for reducing signs and symptoms, inhibiting the progression of structural damage and improving physical function in patients with moderately to severely active RA. REMICADE® is the only biologic indicated for the treatment of patients with moderately-to-severely active CD who have had an inadequate response to conventional therapy. REMICADE® is also indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in patients with fistulizing CD. In December 2004, REMICADE® was approved for reducing signs and symptoms in patients with active AS. In May 2005, REMICADE was approved for reducing signs and symptoms of active arthritis in patients with PsA. Additionally, in September 2005, REMICADE® was approved for reducing signs and symptoms, achieving clinical remission and mucosal healing, and eliminating corticosteroid use in patients with moderately to severely active UC who have had an inadequate response to conventional therapy. This approval makes REMICADE® the first and only biologic approved for the treatment of moderate to severe UC.

REMICADE® is unique among available anti-TNF biologic therapies. Unlike self-administered therapies that require patients to inject themselves frequently, REMICADE® is the only anti-TNF biologic administered directly by caregivers in the clinic or office setting. In RA (3 mg/kg), CD (5 mg/kg), PsA (5 mg/kg), and UC (5 mg/kg), REMICADE® is a two-hour infusion administered every 8 weeks, following a standard induction regimen that requires treatment at weeks 0, 2 and 6. As a result, REMICADE® patients may require as few as six treatments each year. In AS (5 mg/kg), REMICADE® is a two-hour infusion administered every 6 weeks, following a standard induction regimen that requires treatment at weeks 0, 2 and 6.

Important Safety Information
Many people with heart failure should not take REMICADE®; so prior to treatment you should discuss any heart condition with your doctor. Tell your doctor right away if you develop new or worsening symptoms of heart failure (such as shortness of breath or swelling of your ankles or feet).

There are reports of serious infections, including tuberculosis (TB), sepsis and pneumonia. Some of these infections have been fatal. Tell your doctor if you have had recent or past exposure to people with TB. Your doctor will evaluate you for TB and perform a skin test. If you have latent (inactive) TB, your doctor should begin TB treatment before you start REMICADE®. REMICADE® can lower your ability to fight infections, so if you are prone to or have a history of infections, or develop any signs of an infection such as fever, fatigue, cough, or the flu while taking REMICADE, tell your doctor right away. Also tell your doctor if you have lived in a region where histoplasmosis or coccidioidomycosis is common.

There have been rare cases of serious liver injury in people taking REMICADE®, some fatal. Contact your doctor immediately if you develop symptoms such as jaundice (yellow skin and eyes), dark brown urine, right-sided abdominal pain, fever, or severe fatigue.

Blood disorders have been reported, some fatal. Tell your doctor if you develop possible signs of blood disorders such as persistent fever, bruising, bleeding, or paleness while taking REMICADE®. Nervous system disorders have also been reported. Tell your doctor if you have or have had a disease that affects the nervous system, or if you experience any numbness, weakness, tingling, or visual disturbances while taking REMICADE®.

Reports of a type of blood cancer called lymphoma in patients on REMICADE® or other TNF blockers are rare but occur more often than expected for people in general. People who have been treated for rheumatoid arthritis, Crohn’s disease, ankylosing spondylitis, or psoriatic arthritis for a long time, particularly those with highly active disease may be more prone to develop lymphoma. Cancers, other than lymphoma, have also been reported. If you take REMICADE® or other TNF blockers, your risk for developing lymphoma or other cancers may increase. You should also tell your doctor if you have had or develop lymphoma or other cancers while you are taking REMICADE®.

Patients with a specific type of lung disease called COPD (Chronic Obstructive Pulmonary Disease) may be at increased risk for cancer with REMICADE® treatment. If you have COPD, you should discuss with your doctor whether REMICADE® is appropriate for you.

Serious infusion reactions have been reported with REMICADE®, including hives, difficulty breathing, and low blood pressure. Reactions have occurred during or after infusions. In clinical studies, some people experienced the following common side effects: respiratory infections (that may include sinus infections and sore throat), coughing, and stomach pain or mild reactions to infusion such as rash or itchy skin.

Please read important information about REMICADE®, including full U.S. prescribing information, at remicade/.

About Centocor
Centocor is harnessing the power of world-leading research and biomanufacturing to deliver innovative biomedicines that transform patients’ lives. Centocor has already brought innovation to the treatment of Crohn’s disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and ulcerative colitis.

The world leader in monoclonal antibody production and technology, Centocor has brought critical biologic therapies to patients suffering from debilitating immune disorders. Centocor, Inc. is a wholly owned subsidiary of Johnson and Johnson.

Contact: Michael Parks
Centocor, Inc.

View drug information on Remicade.

Researchers have generally believed that teachers are better than parents at evaluating the behavior of school children, because teachers have a bigger group of children for comparison. A University of Virginia study, however, shows that parents are better at assessing their child’s emotional states, while teachers are better at rating bad behaviors. The results emphasize the importance of teachers and parents working together in the child’s best interest.

Associate professor Timothy Konold, coordinator of research, statistics and evaluation at U.Va.’s Curry School of Education, will report his findings on April 8 at the annual American Educational Research Association (AERA) meeting in San Francisco.

“Our results indicate that both parents and teachers are important considerations when assessing a child’s overall behavioral disposition,” Konold said.

“The results have important implications for the manner in which we collect information on child behavior problems that are used to inform instruction and counseling decisions,” he said.

Konold based his research on ratings given by mothers, fathers and teachers of a representative sample of 562 first-graders in the National Institute of Child Health and Human Development Study of Early Child Care. U.Va. is one of 10 sites of this national, 15-year research project, led by Robert Pianta, an authority on early childhood education, who is also a Curry School education professor.

One of the study’s commonly used questionnaire rating 96 behaviors typically reveals different scores on the same behaviors when mothers, fathers and teachers evaluate their children, said Konold, who sought to determine which rating was a better assessment.

What he found is that parents’ scores are better indicators of emotional behaviors, such as being anxious, sad or lonely, or making physical complaints (real or imagined).

“Parents do a much better job of assessing internalizing behaviors, so we should use their ratings when there’s a discrepancy,” he said.

When it comes to aggressive or other delinquent behaviors, called “externalizing,” teachers make a better assessment, he said. Examples of those behaviors include arguing, teasing, threatening, cheating, swearing and lying. These are behaviors children may have learned from their parents, so the parents don’t necessarily recognize them as deviant as consistently as teachers do.

Konold said researchers have not found these results before because they didn’t have an approach for disentangling the variations attributable to the method being used to collect the ratings from observers and what the ratings were actually designed to measure (behavior problems). He used a more modern methodology developed in the last decade to make it possible for educators to interpret the measurements more effectively.

Anne Bromley
aeb3hvirginia.edu
University of Virginia
www.virginia.edu

UroToday – Surgery of duplicated systems is uncommon in the adult population and for this reason I thought this paper would be interesting for the pediatric forum.

Typically an operation for a duplex system entails an ablative procedure at the kidney level or a reimplantation at the bladder level. This group from India reported their preliminary experience with transperitoneal laparoscopic pyeloureterostomy for a duplicated collecting system. Since January 2003, two adult patients with incomplete duplication of ureter with ureteropelvic junction obstruction of the lower moiety and a 4-month-old male baby with complete duplication of the ureter with reflux in the lower moiety underwent transperitoneal laparoscopic pyeloureterostomy. The baby also had excision of the lower moiety ureter. There were no intraoperative or postoperative morbidity to comment upon.

Follow-up imaging revealed good drainage of the systems. It confirms that with increasing experience in laparoscopy, reconstructive urologic procedures are possible even in infants. Over the past year, I have utilized an upper to lower pole ureteroyelostomy in a number of cases where the upper pole moiety had excellent function. Albeit the overall function of the upper pole moieties have minimal contribution, the reconstruction adds little risk to the lower moiety in comparison to a heminephrectomy that carries risk of injury to the lower pole vessels.

In the case of the lower pole moiety, it does contribute the majority of function for that side and should be preserved if it is viable. I feel that having the option to ablate or reconstruct allows us make the best decision for our patients without being obligated to one or two maneuvers for a curative outcome.

By Pasquale Casale, MD

Reference:
Journal of Endourology 20(2): 115-118, Feb 2006.
Link Here

Ramalingam M, Selvarajan K, Senthil K, Pai MG.

UroToday – the only urology website with original content global urology key opinion leaders actively engaged in clinical practice.

To access the latest urology news releases from UroToday, go to:
urotoday

Copyright © 2006 – UroToday

Scientists at UCL (University College London) have measured responses to pain in the brains of premature babies and have shown that they are likely to experience ‘true’ pain rather than simply displaying reflex reactions.

The paper, published today in The Journal of Neuroscience, illustrates that routine care procedures for premature babies, such as heel-lancing for blood tests, can cause pain in premature infants. This study, undertaken on infants in the neonatal unit at the Elizabeth Garrett Anderson and Obstetric Hospital, is the first direct scientific measure of pain in premature babies.

Professor Maria Fitzgerald, UCL Department of Anatomy and Developmental Biology, who led the team, said: “The uncertainties regarding pain management in preterm infants have been increasingly highlighted in recent years and there is a lack of basic information about effective methods of pain control in the youngest patients. As a result, while considerable effort is made to provide clinical pain-control in babies undergoing invasive procedures, this remains suboptimal in many units.

Until now, there has been limited information about pain in premature babies because measuring pain in pre-verbal children is difficult. While previous research shows that even the youngest newborn infants are capable of displaying behavioural, physiological and metabolic signs of pain and distress, the measures are all indirect and could be dismissed as bodily reflex reactions, rather than measures of true pain experience.”

Brain scans taken while babies were having blood tests registered a surge of blood and oxygen in the sensory area in babies’ brains, which indicates that the pain was processed in the higher levels of the brain. The somatosensory cortex is involved in processing sensations from the body surface and is known to be linked to pain sensation in adults.

The results were found using near-infrared spectroscopy, which – like fMRI scans – works by measuring blood levels and oxygenation in the brain. During clinical care work, essential for ensuring a premature baby’s stability, eighteen babies aged between 25 and 45 weeks from conception were studied. Scientists registered the brain activity in the babies at the moments before, during and after nurses performed routine blood tests using a heel lance.

Professor Fitzgerald added: “The importance of this is clear. The UK has the highest rate of low birth-weight babies in Western Europe; 12% all babies born need some level of special care at birth (- 80,000 per annum) and 2.5% need neonatal intensive care (- 17,000 per annum). Estimates show that in intensive care each baby is subjected to an average of 14 procedures per day, many of which are considered by clinical staff to be painful, such as heel lancing for blood tests and inserting chest tubes. Furthermore there is evidence that these repeated painful procedures are a significant stressor and lead to increased sensitivity to other non-painful procedures. Since pain information is transmitted to the preterm infant cortex from 25 weeks there is the potential for pain experience to influence brain development from a very early age as the brain is highly malleable at this stage of development.”

###

The study was funded by the Wellcome Trust London Pain Consortium and the UCLH Special Trustees.

Key facts (from the premature baby charity: Bliss)

* There are approximately 255 units in the UK offering neonatal intensive care, high dependency or special care.

* Only 20 per cent of hospital units specializing in neonatal care in the UK have a procedure for managing pain in premature babies.

* Premature baby: Born before 37 weeks
Moderately premature baby: Born between 35 and 37 weeks
Very premature baby: Born between 29 and 34 weeks
Extremely premature baby: Born between 24 and 28 weeks
Low birthweight baby: Weighs less than 2,500g (5.5 lbs)
Very low birthweight baby: Weighs less than 1,500gms (3.0 lbs)

* The UK has the highest rate of low birthweight babies in Western Europe. Source: Birth Counts, statistics of pregnancy and childbirth Volume 2

* NHS hospital deliveries in England by birthweight (2003-4) – singletons: Number of births between 1,000 gms – 2,499 gms: 39,000

* NHS hospital deliveries in England by gestation (2003-4) – singletons: Estimated Number of births from 22 to 36 weeks: 42,500

* Babies born at 25 weeks have a 50 per cent chance of survival.

Contact: Alex Brew
a.brewucl.ac
University College London

Centocor, Inc., announced today that the supplemental Biologics License Application (sBLA) for REMICADE® (infliximab) for the treatment of pediatric Crohn’s disease has been accepted and designated for Priority Review by the U.S. Food and Drug Administration (FDA). Centocor, Inc., is seeking approval for the treatment of moderately to severely active pediatric Crohn’s disease in patients who have had an inadequate response to conventional therapies. Currently, there are no approved biologic therapies for the treatment of pediatric Crohn’s disease, a chronic, potentially debilitating condition that causes inflammation of the gastrointestinal tract, typically resulting in symptoms such as diarrhea, fever, abdominal pain and weight loss. Children with Crohn’s disease may also experience delayed development and stunted growth. Orphan drug designation was granted by the FDA to REMICADE® for the treatment of pediatric Crohn’s disease on November 12, 2003. In addition, on August 30, 2004, REMICADE® phase III clinical development program for pediatric Crohn’s disease was designated Fast Track by the FDA.

The filing is based primarily on Phase 3 study results showing the unprecedented efficacy of REMICADE® in the treatment of children with moderately to severely active Crohn’s disease. In the REACH (A Randomized, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Anti-TNF Monoclonal Antibody REMICADE in Pediatric Subjects with Moderate to Severe Crohn’s Disease) trial, nearly 90 (88.4 percent) of pediatric patients with moderately to severely active Crohn’s disease who had an inadequate response to conventional therapy achieved clinical response at week 10 when treated with REMICADE®. Nearly two-thirds (63.5 percent) of the patients who were randomized to treatment with REMICADE® every eight weeks were in clinical response at one year. Additionally, more than half of the patients treated with REMICADE® every eight weeks were in clinical remission at the end of one year.

“We are extremely pleased by the results of the REACH trial and by the FDA’s decision to accept the application with a Priority Review,” said Jerome A. Boscia, M.D., senior vice president, Clinical Research and Development, Centocor, Inc. “REMICADE®, if approved for the treatment of pediatric Crohn’s disease, would represent a major advancement for children with this serious condition. We look forward to working closely with the FDA as it reviews these data for approval.”

Priority Review is granted by the FDA to products that are considered to be a potential therapeutic advance over current therapies. Acceptance of the sBLA filing does not mean that a license has been issued for this indication nor does it represent any evaluation of the adequacy of the data submitted in the sBLA. REMICADE® was FDA-approved in 1998 as the first biologic treatment for adults with moderate to severe Crohn’s. In September 2005, REMICADE® also became the first approved biologic treatment for moderate to severe ulcerative colitis (UC), making it the only biologic indicated for the treatment of both types of inflammatory bowel disease in adults (IBD).

About REACH

REACH was a randomized, multicenter, open-label study designed to evaluate the safety and efficacy of REMICADE® in pediatric patients with moderate to severe Crohn’s disease. Patients (n=112) aged six to 17 years with moderately to severely active Crohn’s Disease, despite treatment with an immunomodulator +/- corticosteroids, received REMICADE® 5 mg/kg at weeks zero, two and six. One hundred three patients were randomized at week 10 to receive REMICADE® every eight weeks (n=52) or every 12 weeks (n=51) through week 46. Ninety-nine of the 112 patients were in clinical response at week 10. Patients who lost response in the maintenance phase were eligible for a higher or more frequent dose of REMICADE®. Baseline demographic and disease characteristics were similar between groups. The median patient age was 13 years.

Data from the REACH trial showed that 88 percent of patients treated with REMICADE® 5 mg/kg at zero, two and six weeks achieved the primary endpoint of the trial, clinical response at week 10, which was defined as a decrease from baseline of at least 15 points in the Pediatric Crohn’s Disease Activity Index (PCDAI), and a PCDAI less than or equal to 30. Significantly more patients randomized to the REMICADE® maintenance regimen of one infusion every eight weeks demonstrated clinical response and clinical remission at week 54 than those receiving REMICADE® maintenance every 12 weeks, a comparison made to better understand the pediatric dosing regimen. Sixty-three percent of patients (33 of 52) receiving REMICADE® every eight weeks maintained clinical response after one year of treatment compared with 33 percent of patients (17 of 51) receiving maintenance therapy every 12 weeks (P = 0.002). At 54 weeks, 56 percent of patients (29 of 52) receiving REMICADE® maintenance every eight weeks were in clinical remission, as assessed by a PCDAI score of less than or equal to 10, compared with 24 percent (12 of 51) in the every 12-week maintenance group (P < 0.001).

Additionally, some patients in the trial were able to reduce their corticosteroid dose. At baseline, the median average daily corticosteroid dose of randomized patients who were receiving corticosteroids was 0.4 mg/kg/day. By their first maintenance visit (week 14 for the q8 week group and week 18 for the q12 week group), at least half of the patients had discontinued corticosteroids, an important step for many with Crohn’s who experience side effects as a result of corticosteroid use. The median changes from baseline in average daily corticosteroid dose at weeks 10, 30 and 54 were -0.2, -0.3 and -0.3 mg/kg/day, respectively. The change from baseline in average daily corticosteroid dose was significant (P < 0.001 for all comparisons).

In the REACH trial, patients were closely monitored, and the proportion of patients who experienced adverse events (AEs), serious adverse events (SAEs), serious infections, infusion reactions and immune responses were similar between the eight-week and 12-week REMICADE® maintenance groups. Through the entire clinical trial, the most common SAEs were related to Crohn’s disease. Infections were reported more frequently for subjects who received q8 week as opposed to q12 week infusions (73.6 percent and 38.0 percent, respectively), while serious infections were reported for three patients in the q8 week and four patients in the q12 week maintenance treatment group. As reported by investigators, infections were primarily upper respiratory infections, such as the common cold and bronchitis. Three patients developed antibodies to infliximab, and nine patients in each maintenance group experienced an infusion reaction; there were no serious infusion reactions. No deaths, malignancies, reactivation of latent tuberculosis, neurological disorders or autoimmune disorders were noted. Overall, the AEs were consistent with those seen in previous trials in adult patients. Please see “Important Safety Information” below. REMICADE® has not been studied in patients with pediatric Crohn’s disease six years of age or younger.

About Pediatric Crohn’s Disease

Crohn’s disease is a chronic illness that causes inflammation of the gastrointestinal tract, typically resulting in symptoms such as diarrhea, fever, abdominal pain and weight loss. Children with Crohn’s disease may also experience delayed development and stunted growth. Although it can involve any area of the gastrointestinal tract from the mouth to the anus, it most commonly affects the small intestine and/or colon.

About REMICADE®

REMICADE® is the global market leader among anti-tumor necrosis factor alpha (TNF-alpha) therapies and has demonstrated broad clinical utility in rheumatoid arthritis (RA), Crohn’s disease (CD), psoriatic arthritis (PsA), ulcerative colitis (UC) and ankylosing spondylitis (AS). The safety and efficacy of REMICADE® have been well established in clinical trials over the past 12 years and through commercial experience with over 700,000 patients treated worldwide.

In the U.S., REMICADE®, in combination with methotrexate, is indicated for reducing signs and symptoms, inhibiting the progression of structural damage and improving physical function in patients with moderately to severely active RA. REMICADE® is the only biologic indicated for the treatment of patients with moderately-to-severely active CD who have had an inadequate response to conventional therapy. REMICADE® is also indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in patients with fistulizing CD. In December 2004, REMICADE® was approved for reducing signs and symptoms in patients with active AS. In May 2005, REMICADE® was approved for reducing signs and symptoms of active arthritis in patients with PsA. Additionally, in September 2005, REMICADE® was approved for reducing signs and symptoms, achieving clinical remission and mucosal healing, and eliminating corticosteroid use in patients with moderately to severely active UC who have had an inadequate response to conventional therapy. This approval makes REMICADE® the first and only biologic approved for the treatment of moderate to severe UC.

REMICADE® is unique among available anti-TNF biologic therapies. Unlike self-administered therapies that require patients to inject themselves frequently, REMICADE® is the only anti-TNF biologic administered directly by caregivers in the clinic or office setting. In RA (3 mg/kg), CD (5 mg/kg), PsA (5 mg/kg), and UC (5 mg/kg), REMICADE® is a two-hour infusion administered every eight weeks, following a standard induction regimen that requires treatment at weeks zero, two and six. As a result, REMICADE® patients may require as few as six treatments each year. In AS (5 mg/kg), REMICADE® is a two-hour infusion administered every six weeks, following a standard induction regimen that requires treatment at weeks zero, two and six.

Important Safety Information

Many people with heart failure should not take REMICADE®; so prior to treatment you should discuss any heart condition with your doctor. Tell your doctor right away if you develop new or worsening symptoms of heart failure (such as shortness of breath or swelling of your ankles or feet).

There are reports of serious infections, including tuberculosis (TB), sepsis and pneumonia. Some of these infections have been fatal. Tell your doctor if you have had recent or past exposure to people with TB. Your doctor will evaluate you for TB and perform a skin test. If you have latent (inactive) TB, your doctor should begin TB treatment before you start REMICADE®. REMICADE® can lower your ability to fight infections, so if you are prone to or have a history of infections, or develop any signs of an infection such as fever, fatigue, cough or the flu while taking REMICADE®, tell your doctor right away. Also tell your doctor if you have lived in a region where histoplasmosis or coccidioidomycosis is common.

There have been rare cases of serious liver injury in people taking REMICADE®, some fatal. Contact your doctor immediately if you develop symptoms such as jaundice (yellow skin and eyes), dark brown urine, right-sided abdominal pain, fever or severe fatigue.

Blood disorders have been reported, some fatal. Tell your doctor if you develop possible signs of blood disorders such as persistent fever, bruising, bleeding or paleness while taking REMICADE®. Nervous system disorders have also been reported. Tell your doctor if you have or have had a disease that affects the nervous system, or if you experience any numbness, weakness, tingling or visual disturbances while taking REMICADE®.

Reports of a type of blood cancer called lymphoma in patients on REMICADE® or other TNF blockers are rare but occur more often than expected for people in general. People who have been treated for rheumatoid arthritis, Crohn’s disease, ankylosing spondylitis, or psoriatic arthritis for a long time, particularly those with highly active disease may be more prone to develop lymphoma. Cancers, other than lymphoma, have also been reported. If you take REMICADE® or other TNF blockers, your risk for developing lymphoma or other cancers may increase. You should also tell your doctor if you have had or develop lymphoma or other cancers while you are taking REMICADE®.

Patients with a specific type of lung disease called COPD (Chronic Obstructive Pulmonary Disease) may be at increased risk for cancer with REMICADE® treatment. If you have COPD, you should discuss with your doctor whether REMICADE® is appropriate for you.

Serious infusion reactions have been reported with REMICADE®, including hives, difficulty breathing and low blood pressure. Reactions have occurred during or after infusions. In clinical studies, some people experienced the following common side effects: respiratory infections (that may include sinus infections and sore throat), coughing and stomach pain or mild reactions to infusion such as rash or itchy skin.

Please read important information about REMICADE®, including full U.S. prescribing information, at remicade.

About Centocor, Inc.

Centocor, Inc., is harnessing the power of world-leading research and biomanufacturing to deliver innovative biomedicines that transform patients’ lives. Centocor, Inc., has already brought innovation to the treatment of Crohn’s disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and ulcerative colitis.

The world leader in monoclonal antibody production and technology, Centocor, Inc., has brought critical biologic therapies to patients suffering from debilitating immune disorders. Centocor, Inc., is a wholly owned subsidiary of Johnson & Johnson.

jnj

View drug information on Remicade.