ORIGINAL ARTICLE
Adalimumab for the treatment of moderate to severe
psoriasis: subanalysis of effects on scalp and nails in the
BELIEVE study
D. Thac ßi,
1,
* K. Unnebrink,
2
M. Sundaram,
3
S. Sood,
3
Y. Yamaguchi
3
1
Comprehensive Center for Inflammation Medicine, University of L€ ubeck, L€ ubeck,
2
AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany
3
AbbVie Inc., North Chicago, IL, USA
*Correspondence: D. Thac ßi. E-mail: diamant.thaci@uksh.de
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 betameth-
asone 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; P = 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; P = 0.019) and week
16 (65.0% vs. 73.0%; OR, 0.70; P = 0.052). PASI 75 response rates were 66.1% in patients with scalp and nail involve-
ment and 70.8% in patients without both scalp and nail involvement at week 16 (OR, 0.87; P = 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 Æ SD) decrease from
baseline PSSI at week 16 of 100% (77.2 Æ 96.9%). Patients with nail psoriasis improved, demonstrated by a median
(mean Æ SD) decrease from baseline NAPSI at week 16 of 39.5% (9.4 Æ 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.
Received: 20 December 2013; Accepted: 14 April 2014
Conflicts of interest
Diamant Thac ßi has current consulting/advisory board agreements with Amgen, Biogen Idec, Janssen-Cilag, Celgene
Corp., AbbVie, Pfizer, Leo, MSD, Novartis, and Lilly. Dr. Thac ßi was formerly affiliated with the Department of Dermatol-
ogy, 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
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 sub-
mit 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.
© 2014 European Academy of Dermatology and Venereology JEADV 2015, 29, 353–360
DOI: 10.1111/jdv.12553 JEADV