K A Papp1,2, H Bachelez3, A Blauvelt4, K L Winthrop5, R Romiti6, M Ohtsuki7, N Acharya8, D K Braun8, L Mallbris8, F Zhao8, W Xu8, C D Walls8, B Strober2,9. 1. K. Papp Clinical Research, Waterloo, ON, Canada. 2. Probity Medical Research, Waterloo, ON, Canada. 3. Service de Dermatologie, AP-HP Hôpital Saint Louis, Sorbonne Paris Cité Université Paris Diderot, Paris, France. 4. Oregon Medical Research Center, Portland, OR, U.S.A. 5. Oregon Health and Science University, Portland, OR, U.S.A. 6. Departament of Dermatology, Hospital das Clínicas da Universidade de São Paulo, São Paulo, Brazil. 7. Department of Dermatology, Jichi Medical University, Shimotsuke, Japan. 8. Eli Lilly and Company, Indianapolis, IN, U.S.A. 9. Department of Dermatology, University of Connecticut Health Center, Farmington, CT, U.S.A.
Abstract
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.
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.
Authors: Lawrence F Eichenfield; Thomas Bieber; Lisa A Beck; Eric L Simpson; Diamant Thaçi; Marjolein de Bruin-Weller; Mette Deleuran; Jonathan I Silverberg; Carlos Ferrandiz; Regina Fölster-Holst; Zhen Chen; Neil M H Graham; Gianluca Pirozzi; Bolanle Akinlade; George D Yancopoulos; Marius Ardeleanu Journal: Am J Clin Dermatol Date: 2019-06 Impact factor: 7.403
Authors: Vinod Chandran; Désirée van der Heijde; Roy M Fleischmann; Eric Lespessailles; Philip S Helliwell; Hideto Kameda; Ruben Burgos-Vargas; Janelle S Erickson; Suchitrita S Rathmann; Aubrey Trevelin Sprabery; Julie A Birt; Catherine L Shuler; Gaia Gallo Journal: Rheumatology (Oxford) Date: 2020-10-01 Impact factor: 7.580