TY - JOUR
T1 - Infections from seven clinical trials of ixekizumab, an anti-interleukin-17A monoclonal antibody, in patients with moderate-to-severe psoriasis
AU - Papp, K. A.
AU - Bachelez, H.
AU - Blauvelt, A.
AU - Winthrop, K. L.
AU - Romiti, R.
AU - Ohtsuki, M.
AU - Acharya, N.
AU - Braun, D. K.
AU - Mallbris, L.
AU - Zhao, F.
AU - Xu, W.
AU - Walls, C. D.
AU - Strober, B.
N1 - Publisher Copyright:
© 2017 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.
PY - 2017
Y1 - 2017
N2 - 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 (IRs) per 100 patient-years (PYs) 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. IRs 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.
AB - 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 (IRs) per 100 patient-years (PYs) 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. IRs 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.
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U2 - 10.1111/bjd.15723
DO - 10.1111/bjd.15723
M3 - Article
C2 - 28600810
AN - SCOPUS:85034257477
SN - 0007-0963
VL - 177
SP - 1537
EP - 1551
JO - British Journal of Dermatology
JF - British Journal of Dermatology
IS - 6
ER -