Alan Menter, MD, Stephen K

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Presentation transcript:

Adalimumab therapy for moderate to severe psoriasis: A randomized, controlled phase III trial Alan Menter, MD, Stephen K. Tyring, MD, PhD, MBA, Kenneth Gordon, MD, Alexa B. Kimball, MD, MPH, Craig L. Leonardi, MD, Richard G. Langley, MD, Bruce E. Strober, MD, PhD, Martin Kaul, MD, Yihua Gu, MS, Martin Okun, MD, PhD, Kim Papp, MD Journal of the American Academy of Dermatology Volume 58, Issue 1, Pages 106-115 (January 2008) DOI: 10.1016/j.jaad.2007.09.010 Copyright © 2008 American Academy of Dermatology, Inc. Terms and Conditions

Fig 1 Study design describing 3 treatment periods. DBPC, Double-blind, placebo-controlled; eow, every other week; OLE, open-label extension; PASI, Psoriasis Area and Severity Index. ∗After 80 mg at week 0 and 40 mg at week 1. †After 80 mg at week 16 and 40 mg at week 17. Journal of the American Academy of Dermatology 2008 58, 106-115DOI: (10.1016/j.jaad.2007.09.010) Copyright © 2008 American Academy of Dermatology, Inc. Terms and Conditions

Fig 2 Patient disposition by primary reason. eow, Every other week; IVRS, interactive voice response system. ∗Other includes protocol violation, administrative problem, or other reason for study withdrawal. No patients died. †When patient's response was less than 75% improvement on Psoriasis Area and Severity Index (PASI), IVRS system instructed site not to continue patient into next period. ‡When patient met study criteria for loss of adequate response, IVRS system prompted site to request that patient discontinue. Loss of adequate response was defined as PASI score after week 33 less than 50% reduction relative to week-0 baseline score and at least a 6-point increase in PASI score relative to week-33 PASI score. Journal of the American Academy of Dermatology 2008 58, 106-115DOI: (10.1016/j.jaad.2007.09.010) Copyright © 2008 American Academy of Dermatology, Inc. Terms and Conditions

Fig 3 Percentage of patients achieving at least 75% response in Psoriasis Area and Severity Index score over time using intention-to-treat (ITT) population. Patients with missing scores were considered nonresponders. Week-24 data are pooled efficacy outcomes for all patients who had been randomized to adalimumab at week 0 (ITT analysis). OLE, Open-label extension. ∗P less than .001 versus placebo. Journal of the American Academy of Dermatology 2008 58, 106-115DOI: (10.1016/j.jaad.2007.09.010) Copyright © 2008 American Academy of Dermatology, Inc. Terms and Conditions

Fig 4 Photographs of patient randomized in period A to adalimumab. A, Baseline (Psoriasis Area and Severity Index [PASI] score = 25.2). B, Week 4 (PASI score = 5.9; 77% improved from baseline). C, Week 16 (PASI score = 1.2; 95% improved from baseline). Journal of the American Academy of Dermatology 2008 58, 106-115DOI: (10.1016/j.jaad.2007.09.010) Copyright © 2008 American Academy of Dermatology, Inc. Terms and Conditions

Fig 5 Time to loss of adequate response for patients rerandomized to continued adalimumab versus those rerandomized to placebo at week 33. Loss of adequate response was defined as Psoriasis Area and Severity Index (PASI) score after week 33 that resulted in less than 50% reduction relative to week-0 baseline score and at least a 6-point increase in PASI score relative to week-33 PASI score. Intention-to-treat analysis based on patients rerandomized at week 33; missing week-52 PASI assessment imputed as loss of adequate response if caused by lack of efficacy or study drug toxicity. Journal of the American Academy of Dermatology 2008 58, 106-115DOI: (10.1016/j.jaad.2007.09.010) Copyright © 2008 American Academy of Dermatology, Inc. Terms and Conditions