Date: Tuesday, November 12, 2019
Session Title: Miscellanous Rheumatic & Inflammatory Disease Poster III: Autoimmune Conditions and Therapies
Session Type: Poster Session (Tuesday)
Session Time: 9:00AM-11:00AM
Background/Purpose: Tildrakizumab (TIL) is a high-affinity anti–interleukin-23p19 monoclonal antibody approved for the treatment of moderate-to-severe plaque psoriasis. The objective of this study was to evaluate severe infections in the phase 3 reSURFACE 1 (NCT01722331) and reSURFACE 2 (NCT01729754) trials.
Methods: This is a post hoc pooled analysis of adult patients with moderate-to-severe plaque psoriasis from two 3-part, parallel group, double-blinded, randomized, controlled trials; reSURFACE 1 (64 week) and reSURFACE 2 (52 week). Detailed methodology has been previously published.1 Safety data over 148 weeks, pooled across trials and treatment groups, were included. Groups were defined as placebo, etanercept (until week 28), TIL 100 mg (100 mg-only in at least 1 part of the study), TIL 200 mg (200 mg-only in at least 1 part of the study), continuous TIL 100 mg (100 mg throughout the 3 double-blind parts plus open-label extension), continuous TIL 200 mg (200 mg throughout all parts), TIL 100/200 mg (any TIL dose in at least 1 part), and continuous TIL 100/200 mg (consistently exposed but dose could change throughout all parts). Severe infections were defined as any infection meeting the regulatory definition of a serious adverse event (SAE) or requiring intravenous antibiotics, irrespective of whether it was reported as an SAE. Exposure-adjusted incidence rates (EAIR) were reported.
Results: Overall, 928 patients on TIL 200 mg, 872 on TIL 100 mg, 316 on continuous TIL 200 mg, 352 on continuous TIL 100 mg, 543 on placebo, 1646 on TIL 100/200 mg, 808 on continuous TIL 100/200 mg, and 313 on etanercept were included. The EAIR of severe infections was 1.12/100 subject-years of exposure among TIL 200 mg, 1.14 (TIL 100 mg), 0.88 (continuous TIL 200 mg), 0.64 (continuous TIL 100 mg), 0.97 (placebo), 1.11 (TIL 100/200 mg), 0.86 (continuous TIL 100/200 mg), and 1.96 (etanercept). Most commonly reported types of severe infections included appendicitis, cellulitis, diverticulitis, and sinusitis.
Conclusion: Tildrakizumab had a favorable long-term safety profile as demonstrated by a low rate of severe infections (lower than etanercept and comparable to placebo) in patients with moderate-to-severe plaque psoriasis.
Editorial support was provided by Puneet Dang, PhD, of AlphaBioCom, LLC.
1. Reich et al., Lancet, 2017; 390(10091): 276-288
To cite this abstract in AMA style:Thaçi D, Reich K, Lambert J, Iversen L, Peserico A, Pau-Charles I, Blauvelt A, Griffiths C. Long-term Safety of Tildrakizumab in Patients with Moderate-to-Severe Plaque Psoriasis: Incidence of Severe Infections Through 3 Years (148 Weeks) from 2 Phase 3 Trials [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/long-term-safety-of-tildrakizumab-in-patients-with-moderate-to-severe-plaque-psoriasis-incidence-of-severe-infections-through-3-years-148-weeks-from-2-phase-3-trials/. Accessed May 30, 2023.
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