Adalimumab (Humira) Rapidly Relieves Pain of Polyarticular Juvenile Rheumatoid Arthritis

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Adalimumab Rapidly Relieves Pain of Polyarticular Juvenile Rheumatoid Arthritis

http://www.medscape.com/viewarticle/547896?src=mp

Results of a phase III trial indicate that adalimumab (Humira) is safe and

effective for treating polyarticular juvenile rheumatoid arthritis (JRA).

Dr. J. Lovell, chairman of the Pediatric Rheumatology Collaborative Study

Group in Cincinnati, Ohio, presented the trial results this week at the American

College of Rheumatology annual scientific meeting in Washington, DC.

" All the anti-TNF agents work by the same basic mechanism, " Dr. Lovell told

Reuters Health. " The big differences are the route of administration - one

subcutaneous injection every 2 weeks for adalimumab - and its safety profile. "

In contrast, etanercept (Enbrel) requires one or two subcutaneous injections per

week, the investigator explained. Infliximab (Remicade) is administered by IV

every 4 to 8 weeks, and may induce infusion reactions or allergic responses.

The study included 171 patients between 4 and 17 years old with polyarticular

JRA, who first participated in a 16-week open-label phase. Adalimumab was

administered at 24 mg/m body surface area (maximum 40 mg/dose). At the end of

this phase, 83% had an American College of Rheumatology 30% improvement (ACR

30), and 52% met criteria for an ACR70 response.

" The response to adalimumab was quick, " Dr. Lovell said. " As early as 2 to 4

weeks, we saw reductions in pain, joint swelling and limitations in movement. "

In the double-blind phase of the trial, 133 responders were randomly assigned to

adalimumab (n = 68) or placebo (n = 65) for 32 weeks, as noted in the meeting

abstract. Patients receiving placebo had nearly twice as many disease flares as

did those in the placebo group.

At the end of 32 weeks, 60% of patients in the adalimumab group had an ACR30

response, versus 35% of those in the placebo group; 56% and 28%, respectively,

met ACR 70 criteria (p < 0.01 for both).

About 65% of subjects in the double-blind trial were also taking methotrexate,

and for these children, the treatment response was even greater. " With

methotrexate, the response was 10% to 20% higher, " Dr. Lovell noted, " so if 60%

of patients had an ACR50 response without methotrexate, 65% to 70% would reach

that level of improvement when methotrexate was part of the treatment. "