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Patients with RA, PsA, AS who have not responded to etanercept, infliximab show response to adalimumab, according to subanalyses

Friday, June 15 2007 | Comments
Evidence Grade 0 What's This?
Adalimumab is an effective and safe treatment in patients with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis who have not responded adequately to prior treatment with etanercept or infliximab, study results indicate.

Dr. Gerd Burmester, lead author of the study, noted that subjects were involved in 3 open-label adalimumab trials--ReAct in RA, STEREO in PsA, and the ongoing RHAPSODY in AS.

The studies included adults who continued to have active disease and had shown an unsatisfactory response or intolerance to >=1 disease-modifying antirheumatic drugs for ReAct or STEREO or >=1 nonsteroidal antiinflammatory drugs for RHAPSODY.

Among the patients who had prior exposure to tumor necrosis factor antagonists, both etanercept and infliximab had to have been discontinued for >=2 months before ReAct, infliximab had to have been discontinued for >=2 months before STEREO or RHAPSODY, and etanercept had to have been stopped for >=3 weeks before STEREO or RHAPSODY.

During the trials, patients added 40 mg of subcutaneous adalimumab to their current regimen every other week for 12 weeks. They could also enter into an optional extension.

The ReAct trial involved 6,610 patients, including 899 who had previously discontinued therapy with etanercept or infliximab. Concomitant DMARDs were taken by 69% of the 899 patients.

After 12 weeks of adalimumab therapy, 60% of the patients who had previously received etanercept or infliximab showed a 20% improvement based on American College of Rheumatology criteria (ACR20), and 33% achieved an ACR50 response. In addition, 76% had a moderate response based on European League Against Rheumatism criteria, and 23% had a good response based on EULAR criteria.

In STEREO, 66 of 442 total subjects had previously discontinued treatment with etanercept or infliximab; 52% were also receiving DMARDs.

After 12 weeks of treatment with adalimumab, these 66 patients had ACR20, ACR50, and ACR70 responses at rates of 67%, 42%, and 25%, respectively. The proportion of patients who had clear or almost clear skin, as measured by the Psoriasis Global Assessment, rose from 33% at baseline to 61% at week 12.

Moreover, 309 of 1,186 patients in RHAPSODY had stopped treatment with etanercept or infliximab as of an April interim analysis.

At week 12, 64% of these patients demonstrated a 20% improvement based on ASsessments in Ankylosing Spondylitis criteria (ASAS 20), 47% had an ASAS 40 response, and 42% had an ASAS 5/6 response.

Overall, adalimumab was well tolerated by the patients who had not responded adequately to or been intolerant of the TNF antagonists.

Dr. Burmester noted that response to adalimumab among the patients who had previously used etanercept or infliximab was only slightly inferior to the response demonstrated by the patients who had not been previously exposed to these therapies.

"[T]he benefit-risk ratio of switching to adalimumab treatment was good in patients with prior anti-TNF therapy, considering the fact that these patients were more severely ill and more difficult to treat," he concluded. (Abstract #OP0045.)

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