ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1503

Safety Profile of Ixekizumab Treatment in Patients with Moderate-to-Severe Plaque Psoriasis and Psoriatic Arthritis: Integrated Analysis of 18 Clinical Trials

Mark Genovese1, Hideto Kameda 2, Proton Rahman 3, Juan Cañete 4, Sandra Garces 5, Wen Xu 6, Matthew M. Hufford 5 and Bernard Combe 7, 1Stanford University, Stanford, CA, 2Toho University, Tokyo, Japan, Tokyo, Japan, 3Memorial University, Newfoundland, NL, Canada, 4Department of Rheumatology, Hospital Clínic, Barcelona, Barcelona, Spain, 5Eli Lilly and Company, Indianapolis, IN, 6Eli Lilly and Company, Indianapolis, 7CHU Montpellier, Montpellier University, Montpellier, France

Meeting: 2019 ACR/ARP Annual Meeting

Keywords: ,

Session Information

Date: Monday, November 11, 2019

Title: Spondyloarthritis Including Psoriatic Arthritis – Clinical Poster II: Treatment of Axial Spondyloarthritis & Psoriatic Arthritis

Session Type: Poster Session (Monday)

Session Time: 9:00AM-11:00AM

Background/Purpose: Ixekizumab (IXE) is a high-affinity monoclonal antibody that specifically targets IL-17A. Pooled safety data from IXE studies in moderate-to-severe plaque psoriasis (PsO) and psoriatic arthritis (PsA) have been reported previously.1, 2 The purpose of this analysis is to report integrated safety results of IXE collected as of March 21, 2019.

Methods: All safety data from controlled and uncontrolled trials were integrated from 14 PsO and 4 PsA studies. The longer-term follow-up was 5 years for PsO trials and 3 years for PsA trials. Safety data were integrated from an all IXE exposure-safety population (defined as all patients receiving ≥1 dose of IXE) by indication. We report exposure-adjusted incidence rates (IRs) per 100 patient-years (PY) at 1-year intervals (over the entirety of exposure) for up to 5 years for adverse events (AEs). Major adverse cerebro-cardiovascular events (MACE) and inflammatory bowel disease (IBD) were adjudicated by an external adjudication committee.

Results: A total of 6091 (17499.3 PY) patients from PsO trials and 1401 (2228.6 PY) patients from PsA trials were analyzed. The Table summarizes safety results for both treatment populations over 1-year intervals. Overall, the IRs for treatment-emergent AEs (TEAEs), serious AEs, and serious infections remained stable with continued IXE exposure, whereas the IRs of patients reporting infections or injection site reactions decreased over time. The most common TEAEs in PsO and PsA were nasopharyngitis, upper respiratory tract infection, and injection-site reaction; most were reported as mild or moderate in severity Opportunistic infections were limited to oral and esophageal candidiasis and localized herpes zoster. Over the entirety of exposure in PsO and PsA studies, respectively, IRs for AEs leading to study drug discontinuation (2.8 and 5.1), serious SAE (5.4 and 6.0) and death (0.2 and 0.3) were reported. The rate of suicide ideation or behavior was 0.1in PsO studies and less than 0.1 in PsA studies. There were no completed suicides in both PsO and PsA studies. In both PsO and PsA studies, IRs for safety topics of special interest in PsO and PsA included, IBD (adjudicated; 0.2 and 0.1), depression (1.2 and 1.7), non-melanoma skin cancer (0.3 and 0.4), other malignancies (0.5 and 0.3) and MACE (0.5 and 0.5), respectively.

Conclusion: The results support a favorable and consistent long-term safety profile of IXE treatment in patients with moderate-to-severe PsO (17499.3 PY) or active PsA (2228.6 PY).

References:

  1. Langley RG, et al. J Eur Acad Dermatol Venereol. 2018;epub ahead of print.
  2. Mease P, et al. Arthritis Care Res (Hoboken) 2018 Aug 29.


Table

Table: Exposure-adjusted incidence rate of TEAEs over time by 1-year interval of exposure to ixekizumab

Disclosure: M. Genovese, AbbVie, 2, 5, Abbvie, 2, 5, AbbVie, Inc., 9, Astellas, 2, 5, Eli Lilly, 2, 5, Eli Lilly and Company, 2, 5, EMD Merck Serono, 2, 5, Galapagos, 2, 5, Galapagos NV, 2, 5, 9, Genentech/Roche, 2, 5, Gilead, 2, 5, Gilead Science, 9, Gilead Sciences, Inc., 2, 5, 9, GSK, 5, Lilly, 2, 5, 9, Novartis, 2, 5, Pfizer, 2, 5, 9, Pfizer Inc, 2, 5, Pfizer, Inc., 9, Pzier, 9, RPharm, 5, Sanofi Genzyme, 2, 5, Vertex, 2, 5; H. Kameda, AbbVie, 5, 8, Asahi-Kasei Pharma, 5, 8, Astellas, 5, 8, BMS, 5, 8, Chugai Pharmaceutical, 5, 8, Eisai, 5, 8, Eli Lilly and Company, 5, 8, Individual(s) Involved* Select who has the financial relationship., Janssen, 5, 8, Mitsubishi-Tanabe, 5, 8, Novartis, 5, 8, Pfizer, 5, 8; P. Rahman, AbbVie, 5, 8, AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Eli Lilly, and Novartis, 8, AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Eli Lilly, Novartis, and UCB, 5, AbbVie, Eli Lilly, Pfizer, Novartis , UCB, 5, 8, Eli Lilly and Company, 5, 8, Janssen, 2, 5, 8, Janssen Inc., 2, 5, 8, Janssen, Novartis, 2, Novartis, 5, 8, Pfizer, 5, 8, UCB, 5, 8; J. Cañete, Eli Lilly and Company, 5, Janssen, 5, 8, Novartis, 5, 8, Mylan, 5, Pfizer, 5, UCB, 5; S. Garces, Eli Lilly and Company, 1, 3; W. Xu, Eli Lilly and Company, 1, 3; M. Hufford, Eli Lilly and Company, 1, 3; B. Combe, AbbVie, 5, BMS, 5, 8, Chugai, 5, 8, Eli Lilly, 5, Eli Lilly and Company, 5, 8, Gilead, 5, 8, Gilead Sciences, Inc., 5, 8, Janssen, 5, Lilly, 5, 8, MSD, 2, 5, 8, Novartis, 5, Pfizer, 2, 5, 8, Roche, 2, 5, 8, Roche-Chugai, 5, 8, Sanofi, 5, UCB, 5, USD, 5.

To cite this abstract in AMA style:

Genovese M, Kameda H, Rahman P, Cañete J, Garces S, Xu W, Hufford M, Combe B. Safety Profile of Ixekizumab Treatment in Patients with Moderate-to-Severe Plaque Psoriasis and Psoriatic Arthritis: Integrated Analysis of 18 Clinical Trials [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/safety-profile-of-ixekizumab-treatment-in-patients-with-moderate-to-severe-plaque-psoriasis-and-psoriatic-arthritis-integrated-analysis-of-18-clinical-trials/. Accessed .

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