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Adalimumab improves symptoms, patient-reported outcomes in patients with psoriasis, PsA, data show

Wednesday, December 12 2007 | Comments

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What's This? Among patients with psoriasis, treatment with adalimumab appears to improve symptoms, regardless of psoriatic arthritis (PsA) status, 16-week data suggest.

The REVEAL study was a 52-week, double-blind, Phase III trial that included 1,212 patients with moderate to severe chronic plaque psoriasis. This analysis was based on data from the first 16 weeks of the trial, in which the patients were randomized to receive placebo (n=398) or adalimumab (n=814) dosed at 80 mg at week 0 and 40 mg every other week from weeks 1 through 15. Of these, 224 patients in the adalimumab group and 113 patients in the placebo group reported having PsA.

The primary endpoint of the analysis was the percentage of patients achieving >=75% improvement in skin clearance, as measured by the Psoriasis Area and Severity Index (PASI 75), at week 16.

Among the patients with comorbid PsA, 69.6% of those who received adalimumab and 5.3% of those who received placebo had achieved a PASI 75 response at week 16, a difference that was statistically significant (P<.001). Further, among the patients who did not have PsA, 71.5% of the adalimumab-treated patients and 7.0% of the placebo-treated patients had achieved a PASI 75 response at week 16, a difference that also was statistically significant (P<.001).

In addition, a statistically significantly higher percentage of the patients who received adalimumab had achieved PASI 50, 90, and 100 responses at week 16 relative to those who received placebo. Specifically, 82% of the adalimumab-treated patients and 15% of the placebo-treated patients had achieved PASI 50, 45% of the adalimumab-treated patients and 2% of the placebo-treated patients achieved PASI 90, and 20% and 1%, respectively, achieved PASI 100.

Mean reductions in pain scores, as measured by a visual analog scale for plaque psoriasis and PsA pain, were statistically significantly greater at week 16 for the patients who received adalimumab as compared with those who received placebo. Further, the patients with comorbid PsA who received adalimumab had a greater magnitude of improvement in pain scores relative to those without PsA who received adalimumab.

In addition, the patients who received adalimumab experienced statistically significantly greater mean improvements in the physical and mental component summaries (PCS, MCS) of the Short Form-36 health survey as compared with the placebo-treated patients.

Regardless of the presence of PsA, the adalimumab-treated patients experienced improvements in their PCS and MCS scores that approximated or exceeded the minimum clinically important difference of 3 to 5 points.

"Though not evaluated statistically, the differences in outcomes between PsA and psoriasis patients may be related to concomitant amelioration of skin and joint symptoms by adalimumab," the authors concluded. (Menter AM, et al. Poster 584.)

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