Journal
JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
Volume 66, Issue 2, Pages 241-251Publisher
MOSBY-ELSEVIER
DOI: 10.1016/j.jaad.2010.12.005
Keywords
adalimumab; anti-tumor necrosis factor therapy; clinical trial; efficacy; long-term treatment; open-label; psoriasis; safety
Categories
Funding
- Abbott Laboratories
- Abbott
- Amgen
- Centocor
- Eli Lilly
- Galderma
- Merck
- Nova Nordisk
- Alza
- Astellas
- Celgene
- Genentech
- Isotechnika
- Janssen-Ortho
- Johnson and Johnson
- Novartis
- Pfizer
- Serono
- Schering-Plough
- UCB
- Wyeth
- Amgen-Wyeth
Ask authors/readers for more resources
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 (PAST 75) at weeks 16 and 33 (sustained responders); (2) less than PAST 75 at week 16; and (3) greater than or equal to PAST 75 at week 16 with 50% to less than 75% improvement in PAST score at week 33. Results were also analyzed for patients who began adalimumab after 16 weeks of placebo therapy. Results: For patients with sustained PAST 75 responses during REVEAL, efficacy was generally well maintained over 3 years, with 75%/90%/100% improvement in PAST 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 PAST 75 responses in REVEAL also achieved long-term PAST 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. (J Am Acad Dermatol 2012;66:241-51.)
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available