Assessing the Impact of Efalizumab on Nail, Scalp and Palmoplantar Psoriasis and on Quality of Life: Results from a Multicentre, Open-label, Phase IIIb/IV Trial

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Abstract

This post-approval, open-label trial ( n = 1266) assessed the efficacy of efalizumab, administered in accordance with the European label at that time, in patients with concomitant nail, scalp or palmoplantar psoriasis. Patients received subcutaneous efalizumab 1.0 mg/kg weekly for up to 20 weeks. By Week 12, an improvement from baseline of 50% or more was observed in 21.4% (181/844) of patients with nail psoriasis, 62.4% (718/1150) of patients with scalp psoriasis, and 51.4% (127/247) of patients with palmoplantar psoriasis. Quality of life improved throughout the trial, with a 50% median improvement in DLQI score after 12 weeks of treatment. Efalizumab showed promising efficacy in the treatment of nail, scalp and palmoplantar psoriasis, which was reflected in improvements in quality of life.

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Most cited references 16

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Efalizumab for patients with moderate to severe plaque psoriasis: a randomized controlled trial.

Marion K. Gordon, Brian Bresnahan, Alicia Hamilton … (2003)

Because T-cell interactions are involved in the pathophysiology of psoriasis, therapy with a T-cell modulator may have beneficial effects on psoriasis severity and health-related quality of life (HRQL). To assess the efficacy and safety of efalizumab, a T-cell modulator, in patients with plaque psoriasis. Phase 3 randomized, double-blind, parallel-group, placebo-controlled trial involving 556 adult patients with stable, moderate to severe plaque psoriasis and conducted at 30 study centers in the United States and Canada between January and July 2002. Patients were randomly assigned in a 2:1 ratio to receive 12 weekly doses of subcutaneous efalizumab, 1 mg/kg (n = 369), or placebo equivalent (n = 187). At least 75% improvement on the Psoriasis Area and Severity Index (PASI-75); improvement on the overall Dermatology Life Quality Index (DLQI), Itching Visual Analog Scale (VAS), and Psoriasis Symptom Assessment (PSA) at week 12 vs baseline. Efalizumab-treated patients experienced significantly greater improvement on all end points than placebo-treated patients. Twenty-seven percent of efalizumab-treated patients achieved PASI-75 vs 4% of the placebo group ( P<.001). Efalizumab-treated patients exhibited significantly greater mean percentage improvement than placebo-treated patients on the overall DLQI (47% vs 14%; P<.001), Itching VAS (38% vs -0.2%; P<.001), and PSA frequency and severity subscales (48% vs 18% and 47% vs 17%, respectively; P<.001 for both) at the first assessment point. Efalizumab was safe and well tolerated, with primarily mild to moderate adverse events. In this 12-week study, efalizumab resulted in significant improvements in clinical end points, including physician-assessed and dermatology-specific patient-reported HRQL measures, in patients with moderate to severe plaque psoriasis.

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Patients with palmoplantar psoriasis have more physical disability and discomfort than patients with other forms of psoriasis: implications for clinical practice.

Rajesh Balkrishnan, S Rapp, Stephen R Rapp … (2003)

Psoriasis is a chronic, unpredictable, and incurable disease that has a negative impact on patients' quality of life. Palm and sole psoriasis can add to this negative impact as it directly affects activities of daily living. We sought to estimate the prevalence of palmoplantar psoriasis in a patient population and to explore associations with patient outcomes. In all, 317 individuals with psoriasis completed a comprehensive assessment battery. Patients with palmoplantar psoriasis (n = 124, 39%) were compared with patients without palmoplantar involvement with respect to functional disability, psychiatric symptoms, physical and social discomfort, self-reported psoriasis severity, and health-related quality of life. Patients with palmoplantar involvement reported significantly greater physical disability and physical discomfort than patients without palmoplantar involvement (both P <.01). There were no differences between the 2 groups with respect to psychosocial outcomes. Patients with palmoplantar psoriasis are affected to a greater degree by the physical aspects of the disease than patients without palmoplantar involvement.

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Psoriasis treatment in difficult locations: scalp, nails, and intertriginous areas.

Gottfried Wozel (2015)

Psoriasis comprises a broad spectrum of different clinical courses among which the chronic stable psoriasis by far occurs most frequently. The clinical presentation ranges from mild disease to more serious forms involving large areas of skin and/or joint disease. A number of modifying factors may impact on treatment choice in individual cases (eg, location of the lesions, disease phase, treatment history, response to previous treatments, comorbidity). Aside from this consideration, there are special localizations that remain some of the most difficult regions to control. Such entities are the scalp, nails, and intertriginous areas. Topical treatment of such different-to-treat areas has to be considered as a first-line intervention strategy, at least in those patients who are presenting an exclusively isolated involvement. In some situations (eg, in severe psoriasis or in patients who are refractory to topical treatment), however, a systemic treatment is indicated. Most obvious difficulties in treating these locations are due to unrealistic expectations from the patients' perspectives, time-consuming applications, side effects, cosmetic injuries, and restricted bioavailability of active compounds. Aside from hair care, initial use of keratolytics for scalp psoriasis, corticosteroids, and vitamin D3 and analogues are currently standard treatments. Recently developed new formulations of both active ingredients such as foam or gel appear to be more acceptable to patients than traditional creams or ointments. Current treatment options for nail psoriasis are very often poorly efficacious, associated with undesirable effects, or time consuming. Success has to be measured in terms of months. Topical treatments (eg, corticosteroids, vitamin D analogues, tazarotene) are mainly used, but impressive improvement rates mostly will be achieved by systemic treatment of conventional and biologic agents. Finally, the usefulness of corticosteroids, vitamin D and analogues, and calcineurin inhibitors in treating intertriginous psoriasis clearly is demonstrated. Especially the use of calcineurin inhibitors exhibits efficacy in intertriginous regions and therefore may be seen as a promising treatment option in the future. Besides the important innovations in the last years, there is a need for new effective and well-tolerated treatment modalities, especially for long-term use in the 3 difficult-to-treat locations, which encompass cosmetic acceptability.

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Author and article information

Journal

Journal ID (nlm-ta): Arch Drug Inf

Journal ID (publisher-id): adi

Title: Archives of Drug Information

Publisher: Blackwell Publishing Inc

ISSN (Print): 1753-5174

ISSN (Electronic): 1753-5174

Publication date (Print): December 2009

Volume: 2

Issue: 4

Pages: 66-70

Affiliations

[* ]simpleDepartment of Dermatology, Andreas Sygros Hospital, University of Athens Athens, Greece

[† ]simpleUniversity of L'Aquila Aquila, Italy

[‡ ]simpleDermatology Clinic, University of Bari Bari, Italy

[§ ]simpleSouthampton General Hospital Southampton, UK

[¶ ]simpleDepartment of Dermatology, Technical University Dresden, Germany

[** ]simpleHospital Universitario de la Princesa Madrid, Spain

[†† ]simpleMerck Serono International S.A. Geneva, Switzerland

[‡‡ ]simpleDepartment of Dermatology, Centre Hospitalier Universitaire Liège, Belgium

Author notes

A. Katsambas, MD, Department of Dermatology, Andreas Sygros Hospital, University of Athens, Athens, Greece. Tel: 0030 210 3619542; Fax: 0030 210 7211122; E-mail: katsabas1@ 123456ath.forthnet.gr

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Article

DOI: 10.1111/j.1753-5174.2009.00023.x

PMC ID: 2805869

PubMed ID: 20098509

SO-VID: 5d7af743-8266-4fa3-b999-65ed76e074ca

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Re-use of this article is permitted in accordance with the Creative Commons Deed, Attribution 2.5, which does not permit commercial exploitation.

Assessing the Impact of Efalizumab on Nail, Scalp and Palmoplantar Psoriasis and on Quality of Life: Results from a Multicentre, Open-label, Phase IIIb/IV Trial

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Most cited references 16

Efalizumab for patients with moderate to severe plaque psoriasis: a randomized controlled trial.

Patients with palmoplantar psoriasis have more physical disability and discomfort than patients with other forms of psoriasis: implications for clinical practice.

Psoriasis treatment in difficult locations: scalp, nails, and intertriginous areas.

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