Association Between Enthesitis and Health-related Quality of Life in Psoriatic Arthritis in Biologic-naive Patients from 2 Phase III Ustekinumab Trials

Iain B McInnes; Lluís Puig; Alice B Gottlieb; Christopher T Ritchlin; Michael Song; Yin You; Shelly Kafka; G James Morgan; Proton Rahman; Arthur Kavanaugh; PSUMMIT 1 and 2 Study Groups

doi:10.3899/jrheum.180792

Association Between Enthesitis and Health-related Quality of Life in Psoriatic Arthritis in Biologic-naive Patients from 2 Phase III Ustekinumab Trials

J Rheumatol. 2019 Nov;46(11):1458-1461. doi: 10.3899/jrheum.180792. Epub 2019 Apr 1.

Authors

Iain B McInnes^{1

2}, Lluís Puig^{3

4}, Alice B Gottlieb^{3

4}, Christopher T Ritchlin^{3

4}, Michael Song^{3

4}, Yin You^{3

4}, Shelly Kafka^{3

4}, G James Morgan^{3

4}, Proton Rahman^{3

4}, Arthur Kavanaugh; PSUMMIT 1 and 2 Study Groups

Affiliations

¹ From the University of Glasgow, Institute of Infection Immunity and Inflammation, Glasgow Biomedical Research Centre, Glasgow, Scotland; Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain; Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York; University of Rochester, Medical Center, Rochester, New York; Janssen Research & Development LLC, Spring House, Pennsylvania; Janssen Scientific Affairs LLC, Horsham, Pennsylvania, USA; Memorial University, St. John's, Newfoundland and Labrador, Canada; University of California-San Diego, San Diego, California, USA. Iain.McInnes@glasgow.ac.uk.
² I.B. McInnes, MD, PhD, University of Glasgow, Institute of Infection Immunity and Inflammation, Glasgow Biomedical Research Centre; L. Puig, MD, PhD, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona; A.B. Gottlieb, MD, PhD, Department of Dermatology, Icahn School of Medicine at Mount Sinai; C.T. Ritchlin, MD, MPH, University of Rochester, Medical Center; M. Song, MD, Janssen Research & Development LLC; Y. You, MS, Janssen Research & Development LLC; S. Kafka, MD, Janssen Scientific Affairs LLC; G.J. Morgan, MD, Janssen Scientific Affairs LLC; P. Rahman, MD, Memorial University; A. Kavanaugh, MD, University of California-San Diego. Iain.McInnes@glasgow.ac.uk.
³ From the University of Glasgow, Institute of Infection Immunity and Inflammation, Glasgow Biomedical Research Centre, Glasgow, Scotland; Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain; Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York; University of Rochester, Medical Center, Rochester, New York; Janssen Research & Development LLC, Spring House, Pennsylvania; Janssen Scientific Affairs LLC, Horsham, Pennsylvania, USA; Memorial University, St. John's, Newfoundland and Labrador, Canada; University of California-San Diego, San Diego, California, USA.
⁴ I.B. McInnes, MD, PhD, University of Glasgow, Institute of Infection Immunity and Inflammation, Glasgow Biomedical Research Centre; L. Puig, MD, PhD, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona; A.B. Gottlieb, MD, PhD, Department of Dermatology, Icahn School of Medicine at Mount Sinai; C.T. Ritchlin, MD, MPH, University of Rochester, Medical Center; M. Song, MD, Janssen Research & Development LLC; Y. You, MS, Janssen Research & Development LLC; S. Kafka, MD, Janssen Scientific Affairs LLC; G.J. Morgan, MD, Janssen Scientific Affairs LLC; P. Rahman, MD, Memorial University; A. Kavanaugh, MD, University of California-San Diego.

PMID: 30936281
DOI: 10.3899/jrheum.180792

Abstract

Objective: Evaluate enthesitis, physical function, and health-related quality of life (HRQOL) among patients with psoriatic arthritis (PsA) who are naive to anti-tumor necrosis factor agents.

Methods: In PSUMMIT 1 and 2, patients with PsA were randomized to placebo or ustekinumab 45 mg or 90 mg. Enthesitis was assessed at weeks 0 and 24 (Maastricht Ankylosing Spondylitis Enthesitis Score). Assessments included Health Assessment Questionnaire-Disability Index (HAQ-DI), Medical Outcomes Study Short Form-36 (SF-36) physical component summary/mental component summary (PCS/MCS), and American College of Rheumatology 20 (ACR20).

Results: At Week 24, 21 had worsened enthesitis, 158 had improved enthesitis, and 412 had unchanged enthesitis. Improved enthesitis was associated with improvements in HAQ-DI and SF-36 MCS. Results were similar for ACR20 responders and nonresponders.

Conclusion: Improvement in enthesitis at Week 24 was associated with improvements in physical function/HRQOL regardless of ACR20 response.

Keywords: ENTHESITIS; HEALTH-RELATED QUALITY OF LIFE; PSORIATIC ARTHRITIS; USTEKINUMAB.

Publication types

Clinical Trial, Phase III
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Antirheumatic Agents / pharmacology
Antirheumatic Agents / therapeutic use*
Arthritis, Psoriatic / complications*
Arthritis, Psoriatic / drug therapy*
Biological Products / therapeutic use*
Enthesopathy / complications*
Female
Humans
Male
Middle Aged
Quality of Life*
Severity of Illness Index
Treatment Outcome
Tumor Necrosis Factor-alpha / antagonists & inhibitors
Ustekinumab / therapeutic use*

Substances

Antirheumatic Agents
Biological Products
Tumor Necrosis Factor-alpha
Ustekinumab