ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1630

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

Lars Iversen1, Christopher EM Griffiths2, Andrea Peserico3, Ignasi Pau-Charles4, Andrew Blauvelt5, Diamant Thaçi6 and Kristian Reich7, 1Aarhus University Hospital, Aarhus, Denmark, 2The University of Manchester, Manchester, United Kingdom, 3DIMED University of Padua, Padua, Italy, 4Almirall R&D, Barcelona, Spain, 5Oregon Medical Research Center, Portland, OR, 6Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany, 7Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, and Skinflammation®, Hamburg, Germany

Meeting: ACR Convergence 2020

Keywords: , , , ,

Session Information

Date: Monday, November 9, 2020

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.

Disclosure: L. Iversen, AbbVie, 2, 5, 8, Amgen, 2, 5, 8, AstraZeneca, 2, 5, 8, Bristol Meyers Squibb, 2, 5, 8, Boehringer Ingelheim, 2, 5, 8, Celgene, 2, 5, 8, Centocor, 2, 5, 8, Eli Lilly, 2, 5, 8, Janssen-Cilag, 2, 5, 8, Kyowa Kirin, 2, 5, 8, LEO Pharma, 2, 5, 8, Merck Sharp & Dohme, 2, 5, 8, Novartis, 2, 5, 8, Pfizer, 2, 5, 8, UCB, 2, 5, 8, Almirall, 2, 5, 8; C. Griffiths, AbbVie, 2, 8, Almirall, 2, 8, Bristol Meyers Squibb, 2, 8, Celgene, 2, 8, Eli Lilly, 2, 8, Galderma, 2, 8, Janssen, 2, 8, LEO Pharma, 2, 8, Novartis, 2, 8, Sandoz, 2, 8, UCB Pharma, 2, 8; A. Peserico, None; I. Pau-Charles, Almirall, 3; A. Blauvelt, AbbVie, 2, 5, 8, Aclaris, 2, 5, Almirall, 2, 5, Arena, 2, 5, Athenex, 2, 5, Boehringer Ingelheim, 2, 5, Bristol Meyers Squibb, 2, 5, Dermavant, 2, 5, Dermira, 2, 5, Eli Lilly, 2, 5, Forte, 2, 5, Galderma, 2, 5, Janssen, 2, 5, LEO Pharma, 2, 5, Novartis, 2, 5, Ortho, 2, 5, Pfizer, 2, 5, Rapt, 2, 5, Regeneron, 2, 5, Sandoz, 2, 5, Sanofi Genzyme, 2, 5, Sun Pharma, 2, 5, UCB Pharma, 2, 5; D. Thaçi, Janssen Research & Development, LLC, 2, AbbVie, 5, 8, Almirall, 5, 8, Bioskin, 5, 8, Boehringer Ingelheim, 5, 8, Celgene, 2, 5, 8, Dignity, 5, 8, Eli Lilly, 5, 8, Galapagos, 5, 8, GlaxoSmithKline, 5, 8, LEO Pharma, 5, 8, Medac, 5, 8, Merck Sharp & Dohme, 5, 8, Morphosys, 5, 8, Novartis, 2, 5, 8, Pfizer, 5, 8, Regeneron, 5, 8, Samsung Sandoz-Hexal, 5, 8, Sanofi, 5, 8, Sun Pharmaceutical Industries, Inc., 5, 8, UCB, 5, 8; K. Reich, Janssen Research & Development, LLC, 2, AbbVie, 2, 5, 8, Affibody, 2, 5, 8, Almirall, 2, 5, 8, Amgen, 2, 5, 8, Biogen, 2, 5, 8, Boehringer Ingelheim, 2, 5, 8, Celgene, 2, 5, 8, Centocor, 2, 5, 8, Covagen, 2, 5, 8, Eli Lilly, 2, 5, 8, Forward Pharma, 2, 5, 8, Fresenius Medical Care, 2, 5, 8, GlaxoSmithKline, 2, 5, 8, Janssen-Cilag, 2, 5, 8, Kyowa Kirin, 2, 5, 8, LEO Pharma, 2, 5, 8, Medac, 2, 5, 8, Merck Sharp & Dohme, 2, 5, 8, Novartis, 2, 5, 8, Miltenyi Biotec, 2, 5, 8, Ocean Pharma, 2, 5, 8, Pfizer, 2, 5, 8, Regeneron, 2, 5, 8, Samsung Bioepis, 2, 5, 8, Sanofi, 2, 5, 8, Takeda, 2, 5, 8, UCB, 2, 5, 8, Valeant, 2, 5, 8, Xenoport, 2, 5, 8.

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 .

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