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Adalimumab for the treatment of moderate to severe psoriasis: subanalysis of effects on scalp and nails in the BELIEVE study

Authors


  • Conflicts of interest

      Conflicts of interest
    • Diamant Thaçi has current consulting/advisory board agreements with Amgen, Biogen Idec, Janssen-Cilag, Celgene Corp., AbbVie, Pfizer, Leo, MSD, Novartis, and Lilly. Dr. Thaçi was formerly affiliated with the Department of Dermatology, Goethe University, Frankfurt am Main, Germany, and received research/educational grants (paid to the university) from Pfizer. Kristina Unnebrink is an employee of AbbVie Deutschland GmbH & Co. KG. Murali Sundaram and Yuji Yamaguchi are employees of AbbVie Inc. Sarika Sood is a former employee of AbbVie Inc.
  • Funding source

      Funding source
    • AbbVie Inc. funded this study and participated in the design and conduct of the study, in the collection, management, analysis and interpretation of data, in the preparation, review and approval of the manuscript and in the decision to submit the manuscript for publication. All authors were also involved in the decision to submit the manuscript for publication, and had the right to accept or reject comments or suggestions.

Abstract

Background/Objective

This post hoc analysis examined the effects of adalimumab in patients with scalp and/or nail psoriasis from BELIEVE (a randomized, controlled, multicentre phase 3 safety and efficacy trial).

Methods

Efficacy was assessed in the pooled treatment group (adalimumab with or without calcipotriol plus betamethasone dipropionate) by Psoriasis Area and Severity Index (75% improvement; PASI 75), Psoriasis Scalp Severity Index (PSSI), Nail Psoriasis Severity Index (NAPSI), Dermatology Life Quality Index (DLQI) and a visual analog scale (VAS) for pain.

Results

Of the 730 enrolled patients, 663 (91.3%), 457 (63.1%) and 433 (60.1%) had psoriasis of the scalp, nails, or both, respectively. Similar proportions of patients with (68.2%) and without (63.5%) scalp involvement achieved a PASI 75 response at week 16 [adjusted odds ratio (OR), 1.34; = 0.320]. PASI 75 response rates were lower in patients with nail psoriasis compared with patients without nail psoriasis at week 8 (53.0% vs. 62.9%; OR, 0.68; = 0.019) and week 16 (65.0% vs. 73.0%; OR, 0.70; = 0.052). PASI 75 response rates were 66.1% in patients with scalp and nail involvement and 70.8% in patients without both scalp and nail involvement at week 16 (OR, 0.87; = 0.423). Patients in all scalp and nail subgroups reported improvements in DLQI and VAS pain scores throughout the study. Patients with scalp psoriasis exhibited large improvements in scalp symptoms demonstrated by a median (mean ± SD) decrease from baseline PSSI at week 16 of 100% (77.2 ± 96.9%). Patients with nail psoriasis improved, demonstrated by a median (mean ± SD) decrease from baseline NAPSI at week 16 of 39.5% (9.4 ± 164.5%).

Conclusion

Our results indicate that adalimumab improves overall psoriasis and scalp and nail symptoms in this patient population with scalp psoriasis and/or nail involvement. In addition, similar PASI 75 response rates are achieved in patients with and without scalp involvement, whereas patients with nail involvement demonstrate a moderate (perhaps delayed) PASI 75 response rate.

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