Date: Monday, November 9, 2020
Session Title: Miscellaneous Rheumatic & Inflammatory Diseases Poster III: Therapies
Session Type: Poster Session D
Session Time: 9:00AM-11:00AM
Background/Purpose: Tildrakizumab (TIL) is a high-affinity anti–interleukin-23p19 monoclonal antibody that is approved for the treatment of moderate to severe plaque psoriasis. The objective of this study was to evaluate major adverse cardiovascular events (MACE) in two phase 3 trials: reSURFACE 1 (NCT01722331) and reSURFACE 2 (NCT01729754).
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 previously been published. 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 ≥1 part of the study), TIL 200 mg (200 mg only in ≥1 part of the study), continuous TIL 100 mg (100 mg throughout the three double-blinded parts plus open-label extension), continuous TIL 200 mg (200 mg throughout all parts), TIL 100/200 mg (any TIL dose in ≥1 part), and continuous TIL 100/200 mg (consistently exposed to TIL, but dose change possible throughout all parts). Exposure-adjusted incidence rates (EAIR) for confirmed MACE (including non-fatal myocardial infarction, non-fatal stroke, unstable angina, coronary revascularization, resuscitated cardiac arrest, and cardiovascular deaths that were confirmed as “cardiovascular” or “sudden”) 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. EAIR for MACE were 0.54 (TIL 200 mg), 0.40 (TIL 100 mg), 0.29 (continuous TIL 200 mg), 0.36 (continuous TIL 100 mg), 0.49 (placebo), 0.47 (TIL 100/200 mg), 0.35 (continuous TIL 100/200 mg), and 0.65 (etanercept) per 100 patient-years of exposure.
Conclusion: Tildrakizumab had a favorable long-term safety profile as demonstrated by a low rate of MACE (comparable to etanercept and placebo) in patients with moderate to severe plaque psoriasis.
To cite this abstract in AMA style:Iversen L, Griffiths C, Peserico A, Pau-Charles I, Blauvelt A, Thaçi D, Reich K. Long-term Safety of Tildrakizumab in Patients with Moderate to Severe Plaque Psoriasis: Incidence of Confirmed Major Adverse Cardiovascular Events Through 3 Years (148 Weeks) from Two Phase 3 Trials [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10). https://acrabstracts.org/abstract/long-term-safety-of-tildrakizumab-in-patients-with-moderate-to-severe-plaque-psoriasis-incidence-of-confirmed-major-adverse-cardiovascular-events-through-3-years-148-weeks-from-two-phase-3-trials/. Accessed May 27, 2023.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/long-term-safety-of-tildrakizumab-in-patients-with-moderate-to-severe-plaque-psoriasis-incidence-of-confirmed-major-adverse-cardiovascular-events-through-3-years-148-weeks-from-two-phase-3-trials/