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Long-term efficacy and safety of adalimumab in patients with moderate to severe psoriasis treated continuously over 3 years: Results from an open-label extension study for patients from REVEAL - 14/01/12

Doi : 10.1016/j.jaad.2010.12.005 
Kenneth Gordon, MD a, Kim Papp, MD, PhD b, Yves Poulin, MD c, Yihua Gu, MS d, Stephen Rozzo, PhD d, Eric H. Sasso, MD d,
a NorthShore University Health System and University of Chicago, Pritzker School of Medicine, Northbrook, Illinois 
b Probity Medical Research, Waterloo, Ontario, Canada 
c Centre Dermatologique du Quebec Metropolitain, Quebec City, Quebec, Canada 
d Abbott Laboratories, Abbott Park, Illinois 

Reprint requests: Eric H. Sasso, MD, Abbott Immunology, 200 Abbott Park Rd, Dept NJ44, Bldg AP34-1N, Abbott Park, IL 60064-6194.

Abstract

Background

REVEAL was a 52-week phase III trial of adalimumab therapy for moderate to severe chronic plaque psoriasis. Patients from REVEAL could enter an open-label extension trial to receive adalimumab for approximately 3 years of total therapy.

Objective

We sought to determine long-term efficacy and safety of continuous adalimumab therapy for patients from REVEAL.

Methods

Efficacy and safety over greater than 3 years of treatment were analyzed for 4 groups of patients from REVEAL. Patients who received adalimumab continuously from baseline were grouped by their responses in REVEAL: (1) greater than or equal to 75% improvement in Psoriasis Area and Severity Index (PASI) score (PASI 75) at weeks 16 and 33 (sustained responders); (2) less than PASI 75 at week 16; and (3) greater than or equal to PASI 75 at week 16 with 50% to less than 75% improvement in PASI score at week 33. Results were also analyzed for patients who began adalimumab after 16 weeks of placebo therapy.

Results

For patients with sustained PASI 75 responses during REVEAL, efficacy was generally well maintained over 3 years, with 75%/90%/100% improvement in PASI score response rates (last observation carried forward) of 83%/59%/33% after 100 weeks and 76%/50%/31% after 160 weeks of continuous therapy. Some patients with less than PASI 75 responses in REVEAL also achieved long-term PASI 75 responses. Efficacy in the placebo/adalimumab group was consistent with the ensemble of results from the other 3 groups. Adverse event rates were consistent with those during REVEAL.

Limitations

The REVEAL study design prevented analyzing all patients from the adalimumab arm as one long-term cohort.

Conclusion

Adalimumab efficacy was well maintained over more than 3 years of continuous therapy for patients with sustained initial PASI 75 responses. Maintenance was best at the PASI 100 level.

Le texte complet de cet article est disponible en PDF.

Key words : adalimumab, anti–tumor necrosis factor therapy, clinical trial, efficacy, long-term treatment, open-label, psoriasis, safety

Abbreviations used : AE, eow, LOCF, OLE, PASI, PASI 50, PASI 75, PASI 90, PASI 100


Plan


 Abbott Laboratories sponsored this study and provided support for manuscript development.
 Disclosure: Dr Gordon has received research support and/or consultant honoraria from Abbott, Amgen, Centocor, Eli Lilly, Galderma, Merck, and Nova Nordisk. Dr Papp is a consultant for and has received honoraria and travel grants from Abbott, Alza, Amgen, Astellas, Celgene, Centocor, Eli Lilly, Genentech, Isotechnika, Janssen-Ortho, Johnson and Johnson, Novartis, Pfizer, Serono, Schering-Plough, UCB, and Wyeth. Dr Poulin is a consultant for and has received grant support and honoraria from Abbott, Amgen-Wyeth, Celgene, Centocor, Isotechnika, Janssen-Ortho, Johnson and Johnson, Novartis, Pfizer, and Schering-Plough. Ms Gu, Dr Rozzo, and Dr Sasso are employees of Abbott Laboratories.
 Trial registration: ClinicalTrials.gov identifier: NCT00237887 (REVEAL) and NCT00195676 (open-label extension); REVEAL registered October 7, 2005, first patient enrolled December 13, 2004.


© 2010  American Academy of Dermatology, Inc.. Publié par Elsevier Masson SAS. Tous droits réservés.
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Vol 66 - N° 2

P. 241-251 - février 2012 Retour au numéro
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