ACR 2019


Conference summaries

Spondyloarthritis Including Psoriatic Arthritis

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

Presented by: Mark Genovese, MD
Stanford University, Stanford, CA, USA
  • Ixekizumab showed a good long-term safety profile with increasing duration of drug exposure with no unexpected safety outcomes and a safety profile that is consistent with previous reports in patients with PsO or PsA.
  • A favorable risk/benefit profile was seen for ixekizumab in both PsO and PsA at up to 3 years of follow-up.

Previous studies analyzing pooled safety data from trials on ixekizumab in moderate-to-severe plaque psoriasis (PsO) and psoriatic arthritis (PsA) have suggested that the safety profile of ixekizumab is consistent between the two indications, and that continued ixekizumab exposure does not increase the rate of adverse events. [1,2]

  • To provide the latest integrated 3 year-follow-up safety results from 17 trials on ixekizumab in PsO and PsA.
  • The study integrated the safety results from ixekizumab-treated patients from phase 1 and 2 trials and from the global and non-global phase 3 and 4 trials in PsO and PsA (PsO, phase 1: I1F-MC-RHAG, I1F-MC-RHBU; phase 2: I1F-MC-RHAJ; phase 3 (non-global): UNCOVER-A, UNCOVER-J, I1F-US-RHBO, I1F-EW-RHBZ phase 3 (global): UNCOVER-1, UNCOVER-2, UNCOVER-3, IXORA-S, IXORA-Q, IXORA-Peds. PsA phase 3 (global): SPIRIT-P1, SPIRIT-P2, SPIRIT-P3; phase 4 (global): SPIRIT-H2H).
  • The analysis comprised 19,727.9 patient years (PYs) (17,499.3 PYs for PsO and 2228.6 PYs for PsA)
  • The most common treatment-emergent adverse events (TEAEs) in PsO (incidence rates (IRs) per 100 PYs) were nasopharyngitis (8.8), upper respiratory tract infections (unspecified: 5.4), and injection site-reaction (3.4).
  • The most common TEAEs in PsA were nasopharyngitis (9.1), upper respiratory tract infections (unspecified: 8.3), and injection site-reaction (7.0).
  • The adverse events of special interest are shown in the Table.
  • The rate of inflammatory bowel disease diagnosis was 0.2 in PsO studies and 0.1 in PsA studies.
  • Opportunistic infections were limited to oral and esophageal Candida and localized herpes zoster.
  • Rate of suicide ideation or behavior was 0.1 in PsO studies and <0.1 in PsA studies; there were no suicides in either PsO or PsA studies.
  • Ixekizumab showed a consistent long-term safety profile with increasing duration of drug exposure within a large database.
  • There were no unexpected safety outcomes.
  • The safety profile is consistent with previous reports in ixekizumab-treated patients with PsO or PsA.
  • The rates of reported adverse events (AEs) remained stable or decreased over time with continued exposure to ixekizumab.

Key messages/Clinical perspectives

  • This analysis supports a favorable risk/benefit profile for ixekizumab in both PsO and PsA at up to 3 years of follow-up.



  1. Langley RG, Kimball AB, Nak H, et al. Long-term safety profile of ixekizumab in patients with moderate-to-severe plaque psoriasis: an integrated analysis from 11 clinical trials. J Eur Acad Dermatol Venereol. 2019;33:333-9.
  2. Mease P, Roussou E, Burmester GR, et al. Safety of Ixekizumab in Patients With Psoriatic Arthritis: Results From a Pooled Analysis of Three Clinical Trials. Arthritis Care Res (Hoboken). 2018;71:367-78.

Present disclosure: The presenter has reported relationships with AbbVie, Astellas, Eli Lilly, EMD Merck Serono, Galapagos, Genentech/Roche, Gilead Sciences, Inc., Glaxo Smith and Klein, Novartis, Pfizer, RPharm, Sanofi Genzyme, Vertex.

Written by: Patrick Moore, PhD

Reviewed by: Alessia Alunno, MD, PhD

Local reviewers: Alessia Alunno, MD, PhD (Italian); Aurélie Najm, MD (French); Yukinori Okada, MD, PhD (Japanese); Fabian Proft, MD (German); Javier Rodríguez-Carrio, MD, PhD (Spanish); Priscilla Wong, MD (Chinese)

Scientific Editor:  Leonard H. Calabrese, DO


A Comparative Analysis of Upadacitinib Monotherapy and Upadacitinib Combination Therapy for the Treatment of Rheumatoid Arthritis from Two Phase 3 Trials

Presented by: Maya H. Buch, MD, PhD - University of Leeds & NIHR Leeds Biomedical Research Centre, Leeds, United Kingdom

Rheumatoid Arthritis Treatment with Filgotinib: Week 156 Safety and Efficacy Data from a Phase 2b Open-Label Extension Study

Presented by: Arthur Kavanaugh, MD - University of California, San Diego School of Medicine, La Jolla, CA, USA


A Phase 1b/2a Trial of Tofacitinib, an Oral Janus Kinase Inhibitor, in Systemic Lupus Erythematosus

Presented by: Sarfaraz Hasni, MD - National Institute of Arthritis, Musculoskeletal, and Skin diseases/ National Institutes of Health, Bethesda, MD, USA

A Phase 3 Randomized Controlled Trial of Anifrolumab in Patients with Moderate to Severe Systemic Lupus Erythematosus

Presented by: Richard A. Furie, MD - Zucker School of Medicine at Hofstra/Northwell, New York, NY, USA


The Burden of Comorbidity in Patients with RA, PsA or SPA in a General Practice Registry

Presented by: Diederik De Cock, PhD - KU Leuven, Leuven, Belgium



Ixekizumab Demonstrates Improvement Comparable to Adalimumab Across ACR Components in Biologic-Naïve Patients with Psoriatic Arthritis

Presented by: M. Elaine Husni, MD, MPH - Dept. of Rheumatologic and Immunologic Diseases, Cleveland Clinic, Cleveland, OH, USA

Tildrakizumab Efficacy on Psoriasis in Patients with Psoriatic Arthritis—An Analysis from a Phase 2 Study

Presented by: Alan M. Mendelsohn, MD - Sun Pharmaceutical Industries, Inc., Princeton, NJ, USA, Princeton, NJ, USA

Development of a Set of ASAS Quality Standards for Adults with Axial Spondyloarthritis

Presented by: Uta Kiltz, MD - Rheumazentrum Ruhrgebiet/Ruhr University Bochum, Herne, Germany

Ixekizumab in Non-Radiographic Axial Spondyloarthritis: Primary Results from a Phase 3 Trial

Presented by: Atul Deodhar, MD, MRCP - Oregon Health & Science University, Portland, OR, USA


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