ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2145

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

Diamant Thaçi 1, Kristian Reich 2, Jo Lydie Lambert 3, Lars Iversen 4, Andrea Peserico 5, Ignasi Pau-Charles 6, Andrew Blauvelt7 and Christopher Griffiths 8, 1Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany, Lübeck, Germany, 2University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Skinflammation®, Hamburg, Germany; Dermatologikum Berlin, Berlin, Germany, Hamburg, Germany, 3Department of Dermatology, Ghent University Hospital, Ghent, Belgium, Ghent, Belgium, 4Department of Dermatology, Aarhus University Hospital, Aarhus, Denmark, Aarhus, Denmark, 5Clinica Dermatologica, Department of Medicine-DIMED University of Padua, Padua, Italy, Padua, Italy, 6Almirall R&D, Barcelona, Spain, Barcelona, Spain, 7Oregon Medical Research Center, Portland, OR, USA, Portland, OR, 8Centre for Dermatology Research, The University of Manchester, Manchester, UK, Manchester, United Kingdom

Meeting: 2019 ACR/ARP Annual Meeting

Keywords: , , ,

Session Information

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.

References:

1. Reich et al., Lancet, 2017; 390(10091): 276-288

Disclosure: D. Thaçi, AbbVie, 5, 8, Almirall, 5, 8, Beohringer Ingelheim, 5, 8, Biogen-Idec, 5, 8, Boehringer Ingelheim, 5, 8, Celgene, 5, 8, Dermira, 5, 8, Dignity, 5, 8, Eli Lilly, 5, 8, Galapagos, 5, 8, GlaxoSmithKline, 5, 8, Janssen-Cilag, 5, 8, Leo, 5, 8, MSD, 5, 8, Mundipharma, 5, 8, Novartis, 5, 8, Pfizer, 5, 8, Regeneron-Sanofi, 5, 8, Roche-Posay, 5, 8, Sandoz, 5, 8, UCB, 5, 8; K. Reich, AbbVie, 5, 8, Abbvie, 5, 8, Affibody, 5, 8, Almirall, 5, 8, Amgen, 5, 8, Biogen, 5, 8, Biogen-Idec, 5, 8, Boehringer Ingelheim, 5, 8, Boehringer Ingelheim Pharma, 5, 8, Celgene, 5, 8, Centocor, 5, 8, Covagen, 5, 8, Forward Pharma, 5, 8, GlaxoSmithKline, 5, 8, Janssen-Cilag, 5, 8, Janssen-Cliag, 5, 8, Kyowa Kirin, 5, 8, Leo, 5, 8, Lilly, 5, 8, Medac, 5, 8, Merck Sharp & Dohme, 5, 8, Miltenyi, 5, 8, Mltenyi, 5, 8, Novartis, 5, 8, Novatris, 5, 8, Ocean Pharma, 5, 8, Pfizer, 5, 8, Samsung Bioepis, 5, 8, Sanofi, 5, 8, Takeda, 5, 8, UCB, 5, 8, Valeant, 5, 8, Xenoport, 5, 8; J. Lambert, Novartis, 5, 8, Leo Pharma, 5, 8, Celgene, 5, 8; L. Iversen, AbbVie, 5, 8, Almirall, 5, 8, Amgen, 5, 8, Celgene, 5, 8, Janssen-Cilag, 5, 8, Leo Pharma, 5, 8, Novartis, 5, 8, AstraZeneca, 5, 8, BMS, 5, 8, Boehringer Ingelheim, 5, 8, Centocor Kyowa, 5, 8, Pfizer, 5, 8, Samsung Biopis, 5, 8, UCB, 5, 8; A. Peserico, None; I. Pau-Charles, Almirall R&D, 3; A. Blauvelt, AbbVie, 2, 5, 8, Aclaris, 2, 5, 8, Akros, 2, 5, 8, Allergan, 2, 5, 8, Almirall, 2, 5, 8, Amgen, 2, 5, 8, Arena, 2, 5, 8, Boehringer Ingelheim, 2, 5, 8, Bristol-Myers Squibb, 2, 5, 8, Celgene, 2, 5, 8, Dermavant, 2, 5, 8, Dermira Inc., 5, 8, Dermira, Inc, 2, 5, Dermira, Inc., 2, 5, Eli Lilly and Co, 2, 5, Eli Lilly and Company, 5, 8, Galderma, 2, 5, Genentech/Roche, 2, 5, 8, GlaxoSmithKline, 2, 5, 8, Janssen, 2, 5, 8, Leo, 2, 5, 8, Meiji, 2, 5, 8, Merck, 5, 8, Merck Sharp & Dohme, 2, 5, Novartis, 2, 5, 8, Pfizer, 2, 5, 8, Purdue Pharma, 2, 5, 8, Regeneron, 2, 5, 8, Revance, 2, 5, 8, Sandoz, 2, 5, 8, Sanofi Genzyme, 2, 5, 8, Sienna Pharmaceuticals, 2, 5, 8, Sun Pharma, 5, 8, Sun Pharmaceutical Industries, Inc, 2, 5, UCB Pharma, 2, 5, 8, Valeant, 2, 5, 8, Vidac, 2, 5, 8; C. Griffiths, AbbVie, 5, 8, Almirall, 5, 8, Bristol-Myers Squibb, 5, 8, Celgene, 5, 8, Galderma, 5, 8, Janssen, 5, 8, LEO, 5, 8, Lilly, 5, 8, Novartis, 5, 8, Sandoz, 5, 8, UCB Pharma, 5, 8.

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 January 29, 2020.

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