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
| Autor: | Gregory S Cameron, Craig L. Leonardi, Michael P. Heffernan, J. Erickson, Daniel K. Braun, Andrew Blauvelt, Mark Lebwohl, Kenneth B. Gordon |
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| Rok vydání: | 2014 |
| Předmět: |
Male
medicine.medical_specialty medicine.drug_class Dermatology Antibodies Monoclonal Humanized Monoclonal antibody Placebo Severity of Illness Index law.invention Randomized controlled trial Psoriasis Area and Severity Index law Internal medicine Psoriasis Humans Medicine Adverse effect Aged Randomized Controlled Trials as Topic Dose-Response Relationship Drug business.industry Interleukin-17 Middle Aged medicine.disease Surgery Ixekizumab Treatment Outcome Chronic Disease Female Dermatologic Agents Interleukin 17 business |
| Zdroj: | Journal of the American Academy of Dermatology. 71:1176-1182 |
| ISSN: | 0190-9622 |
| DOI: | 10.1016/j.jaad.2014.07.048 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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