Rofecoxib approved in US for juvenile RA

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Rofecoxib approved in US for juvenile RA

Sep 20, 2004 Zosia Chustecka

Rofecoxib (Vioxx, Merck & Co) has been approved by the US FDA for the

additional new indication of juvenile rheumatoid arthritis (JRA),

specifically for the relief of signs and symptoms in children 2 years or

older who weigh at least 22 pounds.

It becomes the first and only selective COX-2 inhibitor with this indication

and as such offers a new treatment option and an alternative to nonselective

nonsteroidal anti-inflammatory drugs (NSAIDs) in these children. " As with

adults, some children don't tolerate these drugs well, they can have

gastrointestinal upset and GI bleeding, and the selective coxib offers them

an alternative, " says Dr Chandell Chalom, director of pediatric

rheumatology (Saint Barnabas Pediatric Subspecialty Center, Livingston, NJ).

The symptoms that would prompt her to consider using the selective drug in

place of a traditional NSAID include complaints of abdominal pain or loss of

appetite, she tells rheumawire. She would also consider the switch in a

child who has a lot of bruises, which could be the result of the platelet

effects of the nonselective agents.

" As a pediatric rheumatologist, my immediate goal in treating a child or

adolescent with JRA is to reduce inflammation or swelling of their joints

and to relieve any associated pain, " Chalom comments. " This approval gives

me a new treatment option to offer these patients. "

Chalom was one of the investigators involved in the trial of rofecoxib in

JRA on which the approval was based. The 12-week trial involved 310 patients

(aged 2 to 17) with active pauciarticular or polyarticular JRA, the 2

commonest types of JRA. Children with systemic onset JRA, the most severe

form of the disease, were excluded from this trial, and so the labeling for

the new indication doesn't cover it, " but there is no reason to think that

the drug wouldn't also work in these patients, " says Chalom.

Some of the children with JRA need to take anti-inflammatory drugs for years

at a time, continuously, while others can manage to taper the dose, and some

can stop the drug for periods of time, she comments. " It's very variable. "

Anti-inflammatories are the initial treatment option, and in many children

with pauciarticular JRA, where only 1 or 2 joints are affected, they are

sufficient to control the disease, Chalom explains. Polyarticular JRA is

more severe, and if treatment with an NSAID or a selective COX-2 inhibitor

for 6 to 8 weeks isn't enough to dampen the inflammation, then it may be

time to move on to or add in a disease-modifying antirheumatic drug (DMARD),

she adds. The most commonly used at present is methotrexate, she continues.

" After a few months of methotrexate, if there is still active disease, then

we move on to the biologics. "

Asked to comment about the concerns about cardiovascular risk that have

dogged rofecoxib ever since the finding of an increased incidence of

myocardial infarction in the pivotal VIGOR study, Chalom remarked that

" there has been a lot of opinion, and not a lot of data. Many of the studies

that have been reported have been observational studies, from which it's

difficult to draw any meaningful conclusions. " And she added: " There's never

been any cardiovascular event reported in a child treated with rofecoxib. "