The efficacy and safety of apremilast, etanercept and placebo in patients with moderate-to-severe plaque psoriasis: 52-week results from a phase IIIb, randomized, placebo-controlled trial (LIBERATE)
| Autor: | Zuoshun Zhang, Kristian Reich, Melinda Gooderham, K. Shah, Lawrence Green, J. Soung, Robert M. Day, Anthony Bewley, Vincent Piguet, Joana Carla Soares Gonçalves, I. Khanskaya |
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| Rok vydání: | 2016 |
| Předmět: |
Adult
Diarrhea Male medicine.medical_specialty Placebo-controlled study Pain Dermatology Placebo Severity of Illness Index Etanercept law.invention 030207 dermatology & venereal diseases 03 medical and health sciences 0302 clinical medicine Double-Blind Method Randomized controlled trial law Internal medicine Psoriasis Humans Medicine Respiratory Tract Infections business.industry Pruritus Anti-Inflammatory Agents Non-Steroidal Tension-Type Headache Headache Nausea Middle Aged medicine.disease Thalidomide Infectious Diseases Tolerability Nasopharyngitis 030220 oncology & carcinogenesis Female Original Article Phosphodiesterase 4 Inhibitors Apremilast Symptom Assessment business medicine.drug |
| Zdroj: | Journal of the European Academy of Dermatology and Venereology |
| ISSN: | 0926-9959 0169-0299 |
| DOI: | 10.1111/jdv.14015 |
| Popis: | Background Apremilast, an oral, small-molecule phosphodiesterase 4 inhibitor, has demonstrated efficacy in patients with moderate-to-severe psoriasis. Objective Evaluate efficacy and safety of apremilast vs. placebo in biologic-naive patients with moderate-to-severe plaque psoriasis and safety of switching from etanercept to apremilast in a phase IIIb, randomized, double-blind, placebo-controlled study (NCT01690299). Methods Two hundred and fifty patients were randomized to placebo (n = 84), apremilast 30 mg BID (n = 83) or etanercept 50 mg QW (n = 83) through Week 16; thereafter, all patients continued or switched to apremilast through Week 104. The primary efficacy endpoint was achievement of PASI-75 at Week 16 with apremilast vs. placebo. Secondary endpoints included achievement of PASI-75 at Week 16 with etanercept vs. placebo and improvements in other clinical endpoints vs. placebo at Week 16. Outcomes were assessed through Week 52. This study was not designed for apremilast vs. etanercept comparisons. Results At Week 16, PASI-75 achievement was greater with apremilast (39.8%) vs. placebo (11.9%; P |
| Databáze: | OpenAIRE |
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