Efficacy and safety of ixekizumab over 4 years of open-label treatment in a phase 2 study in chronic plaque psoriasis
| Autor: | Missy McKean-Matthews, Kenneth B. Gordon, Russel Burge, Mark Lebwohl, Andrew Blauvelt, Claus Zachariae, Daniel K. Braun, Alexandra B. Kimball, Gregory S Cameron, Craig L. Leonardi |
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| Rok vydání: | 2018 |
| Předmět: |
Adult
Male medicine.medical_specialty Visual analogue scale Injections Subcutaneous Dermatology Antibodies Monoclonal Humanized Placebo Severity of Illness Index law.invention 030207 dermatology & venereal diseases 03 medical and health sciences Psoriatic arthritis 0302 clinical medicine Randomized controlled trial law Internal medicine Psoriasis medicine Humans 030212 general & internal medicine Adverse effect business.industry Pruritus Interleukin-17 Dermatology Life Quality Index Middle Aged medicine.disease Ixekizumab Treatment Outcome Chronic Disease Quality of Life Female Dermatologic Agents business |
| Zdroj: | Journal of the American Academy of Dermatology. 79:294-301.e6 |
| ISSN: | 0190-9622 |
| DOI: | 10.1016/j.jaad.2018.03.047 |
| Popis: | Background Ixekizumab has demonstrated improvement in patients with moderate-to-severe psoriasis by selectively targeting interleukin-17A, which is a proinflammatory cytokine that is important in the pathogenesis of psoriasis. Objective To report 4-year efficacy and safety results from the open-label extension (OLE) of this phase 2 trial. Methods Analysis was by last observation carried forward. Patients received ixekizumab, 120 mg, and then 80 mg subcutaneously once every 4 weeks. Results Of the patients who completed the randomized placebo-controlled trial, 93% entered the OLE. A 75% reduction in the Psoriasis Area Severity Index score was reported in 82% of patients at week 208 of the OLE. A static Physician's Global Assessment score of 0 or 1 was reported in 64% of patients, and a score of 0 was reported in 45% at week 208. Patients' Dermatology Life Quality Index and Itch Visual Analog Scale scores decreased when compared with baseline. Improvements were observed in other efficacy and health outcome measures. Serious adverse events were observed in 16.7% of patients, and 87% had 1 or more treatment-emergent adverse events. Three patients had serious infections. One patient reported 2 major cardiovascular events. Limitations The study was unblinded and lacked a placebo or active comparator. Conclusions Efficacy was shown to be maintained for up to 4 years of ixekizumab treatment. |
| Databáze: | OpenAIRE |
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