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Infections from seven clinical trials of ixekizumab, an anti‐interleukin‐17A monoclonal antibody, in patients with moderate‐to‐severe psoriasis
Author(s) -
Papp K.A.,
Bachelez H.,
Blauvelt A.,
Winthrop K.L.,
Romiti R.,
Ohtsuki M.,
Acharya N.,
Braun D.K.,
Mallbris L.,
Zhao F.,
Xu W.,
Walls C.D.,
Strober B.
Publication year - 2017
Publication title -
british journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.304
H-Index - 179
eISSN - 1365-2133
pISSN - 0007-0963
DOI - 10.1111/bjd.15723
Subject(s) - ixekizumab , medicine , psoriasis , placebo , incidence (geometry) , etanercept , clinical trial , interleukin 17 , discontinuation , immunology , secukinumab , psoriatic arthritis , cytokine , tumor necrosis factor alpha , pathology , physics , alternative medicine , optics
Summary Background Infections are associated with biological therapies in psoriasis. Objectives To summarize the incidence of infections in patients with moderate‐to‐severe psoriasis treated with ixekizumab, an anti‐interleukin‐17A monoclonal antibody. Methods Infections are summarized from an integrated database of seven controlled and uncontrolled ixekizumab psoriasis trials. Data are presented from placebo‐controlled induction (weeks 0–12; UNCOVER ‐1, UNCOVER ‐2 and UNCOVER ‐3) and maintenance periods (weeks 12–60; UNCOVER ‐1 and UNCOVER ‐2), and all patients exposed to ixekizumab pooled from all seven trials. Comparisons with etanercept were made during the induction period of two trials ( UNCOVER ‐2 and UNCOVER ‐3). Incidence and exposure‐adjusted incidence rates ( IR s) per 100 patient‐years ( PY s) are reported. Results Overall, 4209 patients were treated with ixekizumab (6480 PY ). During induction (weeks 0–12), overall infection rates were higher in patients treated with ixekizumab (27%) vs. placebo (23%, P < 0·05); however, specific infection rates were comparable overall across treatment groups. IR s of infections did not increase with longer‐term exposure. For all patients treated with ixekizumab (all seven trials), the incidence of serious infections was low (2%, IR 1·3). Candida infections, including eight cases of oesophageal candidiasis, were adequately managed with antifungal therapy, were noninvasive and did not lead to discontinuation. Conclusions Overall, infections occurred in a higher percentage of patients treated with ixekizumab vs. placebo during the first 12 weeks of treatment; however, specific infection rates were comparable overall across treatment groups. Incidences of serious infections were low and similar across treatment groups.