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

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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.

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Most cited references 36

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Psoriasis of the nail: anatomy, pathology, clinical presentation, and a review of the literature on therapy.

Denis Sasseville, George Murphy, Channy Muhn … (2007)

Psoriasis is a chronic skin disease that affects millions of people throughout the world. Even though cutaneous signs and symptoms are the most common clinical manifestations, the nails can be involved in up to 50% of cases, and their involvement remains an important yet often overlooked aspect of the disease. There is a broad spectrum of nail dystrophies associated with psoriasis, ranging from the common pitting and loosening of the nail plate to the less frequent discoloration and splinter hemorrhages seen in the nail bed. This article discusses the normal anatomy and embryology of the nail unit as well as the current understanding of the pathogenesis of the disease. It also provides an extensive review of the existing literature with respect to psoriatic nail therapy. Although there have been many recent advances in the treatment of the cutaneous form of the disease-most notably in the field of immunotherapies-the options for nail psoriasis are far more limited. While a number of treatment alternatives currently exist for nail disease, the general paucity of clear evidence regarding these choices often makes it difficult to select the most efficient, safe, and optimal treatment for the patient. Even though the current literature has shown some support for the use of topical, intralesional, radiation, systemic, and combination therapies for nail psoriasis, the available studies lack sufficient power to extrapolate a standardized therapeutic regimen. Therefore, until better-documented evidence validating the treatment options emerges within the literature, clinicians and patients are left with a vague and relatively unproven approach to psoriatic nail disease.

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Treatment of psoriasis.

Erica G. Weinstein, Lara M. Greaves (1995)

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Efficacy and safety of adalimumab across subgroups of patients with moderate to severe psoriasis.

Alan Menter, Kenneth B Gordon, Craig L. Leonardi … (2010)

The phase III randomized controlled evaluation of adalimumab every other week dosing in moderate to severe psoriasis trial (REVEAL) demonstrated adalimumab induced significant improvements and was well tolerated for patients with moderate to severe psoriasis. We sought to determine the efficacy and safety of adalimumab for various subgroups of patients in REVEAL with moderate to severe psoriasis and to determine whether these profiles were consistent with the overall results. Patients (N = 1212) with moderate to severe psoriasis were randomized to adalimumab or placebo during the first 16 weeks of the trial. The primary efficacy endpoint was percentage of patients achieving at least 75% improvement in the Psoriasis Area and Severity Index (PASI) score at week 16. Post hoc subgroup analyses were conducted to determine relationships between adalimumab efficacy and/or safety and age group, sex, race, baseline weight intervals, baseline body mass index, disease duration, baseline severity, prior treatments, and comorbidities. Consistent 75% or greater improvement in the PASI score responses were observed across all patient subgroups, with moderately reduced responses noted for patients in the greater weight and body mass index categories. A multivariate analysis identified treatment received, weight, and age as the most influential factors for mean percentage change in PASI score at week 16. No significant differences in the risk of serious adverse events in adalimumab- versus placebo-treated patients were observed across weight categories or for patients with baseline comorbidities. These subanalyses are limited by their relatively short, 16-week duration. Treatment of moderate to severe psoriasis with adalimumab led to consistent 75% or greater improvement in PASI score response rates across the majority of patient subgroups, with no significant differences in serious adverse events. Copyright 2009 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

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Author and article information

Journal

Journal ID (nlm-ta): J Eur Acad Dermatol Venereol

Journal ID (iso-abbrev): J Eur Acad Dermatol Venereol

Journal ID (publisher-id): jdv

Title: Journal of the European Academy of Dermatology and Venereology

Publisher: BlackWell Publishing Ltd (Oxford, UK )

ISSN (Print): 0926-9959

ISSN (Electronic): 1468-3083

Publication date (Print): July 2014

Publication date (Electronic): 22 June 2013

Volume: 28

Issue: 7

Pages: 882-890

Affiliations

[1 ]Centre Dermatologique du Québec Métropolitain Québec, Canada

[2 ]Bakersfield Dermatology Bakersfield, CA, USA

[3 ]Dalhousie University Halifax, Canada

[4 ]AbbVie Deutschland GmbH & Co KG Ludwigshafen, Germany

[5 ]AbbVie Inc. North Chicago, IL, USA

Author notes

* Correspondence: Y. Poulin. E-mail: poulinyves@ 123456videotron.ca

Conflict of interest YP has received honoraria or grants from AbbVie, Amgen and Janssen for participation on advisory boards, as an investigator, and as a speaker; and has received grants from Celgene, Centocor, Eli Lilly, Incyte, Merck, Novartis, and Pfizer for participation as an investigator. JC has received honoraria or grants from AbbVie and Amgen for participation on advisory boards and as an investigator and speaker; and from Jansen, Celgene, Lilly, Pfizer and Merck as an investigator. RL has received honoraria or grants from AbbVie, Amgen, Celgene, Novartis, and Janssen for participation on advisory boards and as an investigator and speaker, and from Pfizer and Lilly for participation on advisory boards and as an investigator. KU and WV receive a salary and stock options as employees of AbbVie. OG received a salary as a former employee of AbbVie.

Funding sources AbbVie provided funding for this research and its publication, and had input in the design of the study, data collection, data analysis, manuscript preparation, reviews and approval, and publication decisions. All authors had access to the data and were involved with data analysis and interpretation, had input into the decision to submit the publication, contributed to content development, and reviewed and approved the publication.

Previous Presentations A portion of the data in this manuscript was presented as a poster at the 69th Annual Meeting of American Academy of Dermatology in New Orleans, Louisiana, February 4–8, 2011. (Langley RG, Crowley J, Unnebrink K, Goldblum O. Improvement in Nail Psoriasis is Associated With Improved Efficacy Outcomes in Hand and/or Foot Psoriasis in Adalimumab-treated Patients: Subanalysis of REACH.

Article

DOI: 10.1111/jdv.12198

PMC ID: 4229025

PubMed ID: 23790018

SO-VID: 5b04d02b-d718-4459-917b-307138e12d9b

License:

This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.

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

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Abstract

Background

Objective

Methods

Results

Conclusions

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Karger: Dermatology

Most cited references 36

Psoriasis of the nail: anatomy, pathology, clinical presentation, and a review of the literature on therapy.

Treatment of psoriasis.

Efficacy and safety of adalimumab across subgroups of patients with moderate to severe psoriasis.

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