Adalimumab Demonstrates Superior Efficacy in Refractory Psoriasis: A Randomized Clinical Trial

Abstract

Background: Psoriasis is a chronic, immune-mediated inflammatory disease associated with substantial clinical and psychosocial burden. Objectives: This study evaluated the efficacy of adalimumab in patients with refractory psoriasis. Methods: In this randomized, phase 3, open-label, parallel-group trial, 66 patients were assessed for eligibility; 6 were excluded before randomization, and 60 participants were randomized in a 1:1 ratio to either the adalimumab group or the control group. Data collection included demographic characteristics (age and sex), the Psoriasis Area and Severity Index (PASI) to assess disease severity, and the Dermatology Life Quality Index (DLQI) to assess quality of life. Results: Participants aged 18 to 61 years, with an approximately equal male-to-female ratio, showed significant improvements over follow-up. At Week 16, the mean PASI score was 1.73 ± 1.37 in the intervention group and 9.72 ± 8.23 in the control group. After adjustment for baseline PASI score and sex, PASI remained significantly lower in the intervention group, with an adjusted between-group mean difference of -8.51 points (95% CI, -13.12 to -3.90; P < 0.001). Similarly, the mean DLQI score at Week 16 was 5.90 ± 2.79 in the intervention group and 14.40 ± 5.78 in the control group. After adjustment for baseline DLQI score and sex, the adjusted between-group mean difference was -8.84 points (95% CI, -11.28 to -6.40; P < 0.001), favoring adalimumab. At Week 16, PASI 75 was achieved by 100% of patients in the intervention group compared with 46.7% in the control group (relative risk, 2.14; 95% CI, 1.46 to 3.14; P < 0.001). Adverse events were reported in 13.3% of participants in the intervention group and 20.0% in the control group. No serious adverse events were observed during the 16-week study period. Conclusions: Adalimumab was more effective than methotrexate in reducing disease severity and improving quality of life in patients with refractory psoriasis during the 16-week treatment period.