Safety and efficacy of adalimumab treatment in Japanese patients with psoriasis: Results of SALSA study

Abstract

The safety and efficacy of adalimumab were evaluated over 24 weeks in Japanese patients with psoriasis in routine clinical practice. In this multicenter, observational, open-label, postmarketing study, primary efficacy measures included the Psoriasis Area and Severity Index (PASI) and the Dermatology Life Quality Index (DLQI) in all patients with psoriasis. In patients with psoriatic arthritis (PsA), the 28-joint Disease Activity Score (DAS28) and the visual analog scale (VAS) pain were also evaluated. Safety was assessed based on the frequency of adverse drug reactions (ADR). Among patients with psoriasis evaluated for efficacy (n = 604), significant improvements from baseline were observed in mean PASI and DLQI scores at weeks 16 and 24 (all P < 0.0001). Furthermore, in psoriasis patients without PsA, the PASI 75/90 response rates were 55.9%/28.4% at week 16 (n = 306) and 65.6%/43.3% at week 24 (n = 270), respectively. In patients with PsA evaluable for effectiveness, significant improvements from baseline were observed in PASI, DAS28 erythrocyte sedimentation rate, DAS28 C-reactive protein and VAS pain at weeks 16 and 24 (all P < 0.0001). ADR and serious ADR were reported by 26.1% and 3.3%, respectively, of 731 safety evaluable patients with psoriasis; no unexpected safety findings were noted. The safety profile and effectiveness of adalimumab for the treatment of psoriasis in a routine clinical setting were as expected in Japanese patients.

Keywords: drug surveillance; postmarketing; psoriasis; safety; treatment outcome.

Figure 1

Patient disposition. PsA, psoriatic arthritis; PsV, psoriasis vulgaris.

Figure 2

PASI scores for patients with PsV and patients with PsA. Percentage of patients with PASI 75 response and PASI 90 response. PASI score values are means ± SD. Parentheses indicates the number of responders in PASI 75 and PASI 90. *P < 0.0001 for all patients and patients with PsA at weeks 16 and 24 versus baseline by observed case analysis (paired t‐test). PASI, Psoriasis Area and Severity Index; PASI 75, 75% improvement from baseline in the PASI score; PASI 90, 90% improvement from baseline in the PASI score; PsA, psoriatic arthritis; PsV, psoriasis vulgaris; SD, standard deviation.

Figure 3

DAS28‐ESR and DAS28‐CRP and VAS pain score for patients with PsA. DAS28‐ESR, DAS28‐CRP and VAS values are means ± SD. *P < 0.0001 for DAS28‐ESR and DAS28‐CRP at weeks 4, 16 and 24 versus baseline by observed case analysis (paired t‐test). CRP, C‐reactive protein; DAS28, 28‐joint disease activity score; ESR, erythrocyte sedimentation rate; HDA, high disease activity; LDA, low disease activity; PsA, psoriatic arthritis; SD, standard deviation; VAS, visual analog scale.