A 52-week, open-label study of the efficacy and safety of ixekizumab, an anti-interleukin-17A monoclonal antibody, in patients with chronic plaque psoriasis. J Am Acad Dermatol 2014 Dec;71(6):1176-82
Date
09/23/2014Pubmed ID
25242558DOI
10.1016/j.jaad.2014.07.048Scopus ID
2-s2.0-84919783193 (requires institutional sign-in at Scopus site) 94 CitationsAbstract
BACKGROUND: Patients with moderate to severe plaque psoriasis demonstrated positive responses to ixekizumab, an anti-interleukin-17A monoclonal antibody, in a phase-II, randomized, placebo-controlled trial.
OBJECTIVE: We sought to evaluate long-term efficacy and safety of ixekizumab.
METHODS: After receiving 10, 25, 75, or 150 mg of ixekizumab or placebo during randomized, placebo-controlled trial, patients with less than 75% improvement from baseline on the Psoriasis Area and Severity Index (PASI) score (PASI75) entered open-label extension (OLE); patients with PASI75 or higher entered a treatment-free period (weeks 20-32), then entered OLE after meeting response criteria. During OLE, patients received 120 mg of subcutaneous ixekizumab every 4 weeks.
RESULTS: In all, 120 patients entered OLE; 103 completed 52 weeks or more of treatment. Overall, 77% of patients achieved PASI75 at week 52 (nonresponder imputation). Patients who responded to treatment in the randomized, placebo-controlled trial maintained a high-level response by week 52 of OLE (PASI75 = 95%; 90% improvement from baseline on the PASI score = 94%; 100% improvement from baseline on the PASI score = 82%). Irrespective of dose in the randomized, placebo-controlled trial, each group had similar response rates at week 52 of OLE. The exposure-adjusted incidence rate for adverse events was 0.47 and for serious adverse events was 0.06 per patient-year during OLE.
LIMITATIONS: No control group, small sample sizes, and bias toward retention of patients with positive responses limit interpretation.
CONCLUSION: A high proportion of patients responded to ixekizumab therapy and maintained clinical responses over 1 year of treatment with no unexpected safety signals.
Author List
Gordon KB, Leonardi CL, Lebwohl M, Blauvelt A, Cameron GS, Braun D, Erickson J, Heffernan MAuthor
Kenneth Brian Gordon MD Chair, Professor in the Dermatology department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
AgedAntibodies, Monoclonal, Humanized
Chronic Disease
Dermatologic Agents
Dose-Response Relationship, Drug
Female
Humans
Interleukin-17
Male
Middle Aged
Psoriasis
Randomized Controlled Trials as Topic
Severity of Illness Index
Treatment Outcome
