The effect of bodyweight on the efficacy and safety of ixekizumab: results from an integrated database of three randomised, controlled Phase 3 studies of patients with moderate-to-severe plaque psoriasis
| العنوان: | The effect of bodyweight on the efficacy and safety of ixekizumab: results from an integrated database of three randomised, controlled Phase 3 studies of patients with moderate-to-severe plaque psoriasis |
|---|---|
| المؤلفون: | C. Leonardi, Lotus Mallbris, L. Zhang, Lluís Puig, Kristian Reich, Olawale Osuntokun |
| المصدر: | JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau instname |
| سنة النشر: | 2016 |
| مصطلحات موضوعية: | Adult, Male, medicine.medical_specialty, Adolescent, Subgroup analysis, Dermatology, Placebo, Antibodies, Monoclonal, Humanized, Severity of Illness Index, Etanercept, law.invention, 030207 dermatology & venereal diseases, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Randomized controlled trial, Double-Blind Method, law, Internal medicine, Psoriasis, Severity of illness, medicine, Humans, Multicenter Studies as Topic, 030212 general & internal medicine, Adverse effect, Aged, Randomized Controlled Trials as Topic, business.industry, Body Weight, Middle Aged, medicine.disease, Ixekizumab, Infectious Diseases, Clinical Trials, Phase III as Topic, Physical therapy, Female, Dermatologic Agents, business, medicine.drug |
| الوصف: | Background There is concern that increased bodyweight may impact efficacy of some therapies used to treat psoriasis. Objective To evaluate the effect of bodyweight on response to ixekizumab treatment in patients with moderate-tosevere psoriasis. Methods Patients were characterized under three bodyweight categories (< 80 kg, 80 to < 100 kg, >= 100 kg) in this pre-planned subgroup analysis from an integrated database of three multicenter, randomised, double-blind, controlled Phase 3 clinical studies (UNCOVER-1, UNCOVER-2 and UNCOVER-3). In the first 12 weeks of each study, patients were randomly assigned to receive subcutaneous placebo, 80-mg ixekizumab every 2 weeks (IXE Q2W) or every 4 weeks (IXE Q4W) after a starting dose of 160-mg ixekizumab, or 50-mg etanercept twice weekly (UNCOVER-2 and UNCOVER-3 only). Results This analysis included 3855 patients with baseline bodyweight in the IXE Q4W (N = 1159), IXE Q2W (N = 1168), placebo (N = 789) and etanercept (N = 739) groups. Distribution of patients across bodyweight categories was similar between treatment groups. Baseline demographics and patients characteristics were generally consistent across treatment groups within each bodyweight category. Across all bodyweight categories, a significantly higher percentage of patients treated with IXE Q2W or IXE Q4W than with placebo or etanercept achieved PASI 75, PASI 90 or PASI 100 at Week 12. No meaningful differences in PASI 75 response rates were observed across bodyweight categories. Some numerical differences in PASI 90 and PASI 100 response rates were observed between bodyweight categories with IXE Q2W providing numerically higher response rates than IXE Q4W. The incidence of treatment-emergent adverse events was similar in the treatment groups and across bodyweight categories. Conclusion Ixekizumab was efficacious in the treatment of moderate-to-severe psoriasis regardless of bodyweight. The safety profile of ixekizumab was also similar across bodyweight categories, and no safety signals were identified specific to any of the bodyweight categories. |
| تدمد: | 1468-3083 0926-9959 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3fdb50496133e8eeff65dded902a5ae8 https://pubmed.ncbi.nlm.nih.gov/28370467 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....3fdb50496133e8eeff65dded902a5ae8 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 14683083 09269959 |
|---|