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Achieving minimal disease activity in psoriatic arthritis predicts meaningful improvements in patients

Author

Coates LC1, Orbai AM2, Morita A3, Benichou O4, Kerr L5, Adams DH5, Shuler CL5, Birt J5, Helliwell PS6. BMC Rheumatol. 2018 Aug 13;2:24. doi: 10.1186/s41927-018-0030-y. eCollection 2018.

Author Information

1 Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, Windmill Road, Oxford, OX3 7LD UK.

2 Johns Hopkins University School of Medicine, Baltimore, MD USA.

3 Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.

4 Laboratoires Lilly France, Neuilly, France.

5 Eli Lilly and Company, Indianapolis, IN USA.

6 University of Leeds School of Medicine, Leeds, UK.

Abstract

BACKGROUND: 

Although psoriatic arthritis is complex and involves multiple domains, recent advances in treatments have made remission or near-remission of most symptoms a potentially achievable goal for many patients. We sought to evaluate whether achieving minimal disease activity (MDA) criteria represented meaningful improvement from the patient perspective.

METHODS: 

Data were combined from two randomized, multinational, 24 week clinical studies of ixekizumab, a high-affinity monoclonal antibody selectively targeting interleukin-17A, in biological drug-naïve or experienced adults. MDA required 5 of 7 of: tender joint count ≤1; swollen joint count ≤1; Psoriasis Area and Severity Index total score ≤ 1 or body surface area ≤ 3%; patient's assessment of pain visual analogue scale (VAS) ≤15; patient's global assessment of disease activity VAS ≤20; Health Assessment Questionnaire Disability Index ≤0.5; and tender entheseal points ≤ 1. MDA responders and non-responders were compared for mean change from baseline on the 36-Item Short Form Health Survey (SF-36), European Quality of Life 5 Dimension 5 Level Health Questionnaire (EQ-5D-5 L); EQ-5D-5 L VAS; and Work Productivity and Activity Impairment-Specific Health Problem (WPAI-SHP) questionnaire.

RESULTS: 

MDA responders had significantly greater improvements versus non-responders in each SF-36 domain and in the SF-36 physical summary score; improvements were also greater in the EQ-5D-5 L and EQ-5D-5 L VAS, and in 3 of the 4 WPAI-SHP domains. MDA responders were more likely to achieve minimal clinically important differences than non-responders.

CONCLUSION: 

These findings support MDA response as being strongly associated with achieving improved disease status based on measures of patient reported health-related quality of life and productivity.

TRIAL REGISTRATION: 

SPIRIT-P1, NCT01695239, First Posted: September 27, 2012; and SPIRIT-P2, NCT02349295, First Posted: January 28, 2015.