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Adalimumab safe, effective in anti-TNF-pretreated patients with PsA, study data show

Monday, June 18 2007 | Comments

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What's This? Adalimumab appears effective and well tolerated in the treatment of patients with psoriatic arthritis, providing improvements in both skin disease and arthropathy, according to findings from the STEREO trial.

In the open-label prospective trial, 442 patients with active PsA and insufficient response to at least 1 disease-modifying antirheumatic drug received adalimumab 40 mg every other week for 12 weeks, with an optional extension to 20 weeks. Joint and skin evaluations were performed at weeks 2, 6, and 12 and included evaluation for 20%, 50%, and 70% improvement based on American College of Rheumatology criteria (ACR20, ACR50, and ACR70, respectively), Physician's Global Assessment (PGA) of psoriasis, and Dermatology Life Quality Index (DLQI).
 
Overall, of the 414 patients assessable for response at week 12, 74% achieved an ACR20 response, 51% achieved an ACR50 response, and 32% achieved an ACR70 response. Mean Disease Activity Score also improved, from 4.9 at baseline to 2.7 at week 12. In addition, mean scores on the Health Assessment Questionnaire (HAQ) improved from 1.24 at baseline to 0.71 at week 12.

"You see an improvement in the HAQ score, which is ... higher than the minimum clinically important difference already at week 2 ... that is sustained and is even growing at week 12," said Dr. Filip Van den Bosch, the lead researcher who presented the data.

Further, the proportion of patients who were deemed clear/almost clear according to PGA criteria improved from 34% at baseline to 68% at week 12. DLQI scores also improved from 6.6 at baseline to 2.6 at week 12, and mean score in the Nail Psoriasis Severity Index improved from 20.6 at baseline to 11.5 at week 12.

A total of 66 patients (15%) had experienced prior failed response to an anti-tumor necrosis factor agent. Among these patients, 67% achieved ACR20, 42% achieved ACR50, and 25% achieved ACR70 at week 12.

"These data from the STEREO trial confirm that adalimumab is well tolerated by patients with PsA and achieves clinically important improvements both in the skin disease and in the arthropathy, including in patients with prior exposure to other biologics," Dr. Van den Bosch and colleagues concluded.

"We found no new safety signals," Dr. Van den Bosch added. "In particular, no safety signals were noted in patients who had prior experience [with] other biologics, and it is a similar safety profile that is emerging when we are using [adalimumab] in a daily setting ...." (Abstract #OP0147.)

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