Efficacy of adalimumab across subgroups of patients with moderate-to-severe chronic plaque psoriasis of the hands and/or feet: post hoc analysis of REACH

Abstract

Background: The Randomized Controlled Evaluation of Adalimumab in Treatment of Chronic Plaque Psoriasis of the Hands and Feet (REACH) trial demonstrated that adalimumab was efficacious and well-tolerated for the treatment of hand and/or foot psoriasis through 28 weeks.

Objective: To evaluate the effects of patient baseline characteristics on efficacy of adalimumab treatment of hand and/or foot psoriasis.

Methods: Patients with moderate-to-severe chronic plaque psoriasis of the hands and/or feet were randomized 2 : 1 to adalimumab or placebo during the 16 week, double-blind period of REACH. Primary endpoint was percentage of patients achieving Physician's Global Assessment of the hands and/or feet of clear/almost clear at week 16. Post hoc analyses evaluated effects of baseline patient characteristics on the primary endpoint. Patients with nail psoriasis at baseline were assessed for association of Nail Psoriasis Severity Index (NAPSI) 50 response with efficacy outcomes at week 16.

Results: Seventy-two patients (49 adalimumab : 23 placebo) were analysed. Greater percentages of adalimumab-treated patients achieved the primary endpoint vs. placebo across all subgroups. Among 31 patients with nail psoriasis, a greater percentage of adalimumab-treated patients achieved NAPSI 50 (56.5%) vs. placebo (12.5%) at week 16. In adalimumab-treated patients, greater percentages of NAPSI 50 Responders vs. Non-responders achieved the primary endpoint, and had greater improvements in erythema, scaling, induration and fissuring, Dermatology Life Quality Index, and pain scores.

Conclusions: Adalimumab was efficacious in treating chronic plaque psoriasis of the hands and/or feet over 16 weeks, regardless of baseline characteristics. Marked improvement in nail psoriasis among adalimumab-treated patients correlated with significant improvements in skin disease and patient-reported outcomes.

Figure 1

Study design. ^aFrom week 1, after an 80 mg dose at week 0. ^bPrimary Endpoint was proportion of patients with Physician’s Global Assessment of hands and/or feet (hfPGA) of clear or almost clear at week 16. ^cFrom week 17, after an 80 mg dose at week 16. n: efficacy analysis set.

Figure 2

Percentages of patients with week 16 hfPGA score of clear or almost clear by baseline characteristics. (a) Age, gender, weight, and psoriasis area severity index (PASI) score. Analysed by non-responder imputation. (b) Duration of hand and/or foot psoriasis, history of psoriatic arthritis (PsA), prior systemic therapy, smoking status, and nail involvement. Analysed by non-responder imputation. N = number of patients with the corresponding characteristic at baseline; n = number of patients with week 16 hfPGA score of clear or almost clear.

Figure 3

Results for patients by Nail Psoriasis Severity Index (NAPSI) 50 response at week 16. (a) Percent of patients achieving NAPSI 50 at week 16 (Responders), among 31 patients with nail psoriasis at baseline. As observed. (b) Percentages of NAPSI 50 Responders and Non-Responders at week 16 who achieved hfPGA score of clear or almost clear at week 16. Non-responder imputation. (c) Mean percent improvements from baseline in ESIF, DLQI and pain Visual Analogue Scale (VAS) scores for NAPSI 50 Responders and Non-Responders at week 16. Patients receiving PBO were not included in these analyses due to the small number (Responders, N = 1; Non-Responders, N = 7). ESIF, Erythema, Scaling, Induration and Fissuring; DLQI, Dermatology Life Quality Index; VAS, visual analogue scale. Last observation carried forward.

Figure 4

Nail psoriasis improvement in one patient. Images from a white, 63-year-old male patient, illustrate improvement in the patient’s nail psoriasis (left hand, digit 4) from baseline to week 16 following adalimumab treatment. This patient was previously treated with corticosteroids and infliximab, but did not achieve response with infliximab. Nail Psoriasis Severity Index target fingernail scores range from 0 to 8.