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

• Published in: Journal of the American Academy of Dermatology Vol. 66; no. 2; pp. 241 - 251
• Main Authors: Gordon, Kenneth, MD, Papp, Kim, MD, PhD, Poulin, Yves, MD, Gu, Yihua, MS, Rozzo, Stephen, PhD, Sasso, Eric H., MD
• Format: Journal Article
• Language: English
• Published: New York, NY Mosby, Inc 01.02.2012; Elsevier
• Subjects: Adalimumab; Adult; Antibodies, Monoclonal, Humanized - adverse effects; Antibodies, Monoclonal, Humanized - therapeutic use; anti–tumor necrosis factor therapy; Biological and medical sciences; clinical trial; Dermatology; Drug-Related Side Effects and Adverse Reactions; efficacy; Female; Humans; long-term treatment; Male; Medical sciences; Middle Aged; open-label; psoriasis; Psoriasis - drug therapy; Psoriasis. Parapsoriasis. Lichen; safety; Treatment Outcome; long-term treatment; PASI 90; PASI 50; LOCF; open-label; PASI 75; OLE; 75% improvement in Psoriasis Area and Severity Index score; eow; Psoriasis Area and Severity Index; adalimumab; 50% improvement in Psoriasis Area and Severity Index score; PASI 100; safety; clinical trial; PASI; AE; every other week; adverse events; 100% improvement in Psoriasis Area and Severity Index score; efficacy; last observation carried forward; open-label extension; psoriasis; 90% improvement in Psoriasis Area and Severity Index score; anti–tumor necrosis factor therapy; Human; Immunomodulator; Skin disease; Treatment; Psoriasis; Dermatology; Antipsoriatic agent; Adalimumab; Long term
• ISSN: 0190-9622; 1097-6787
• DOI: 10.1016/j.jaad.2010.12.005

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.