Measuring treatment effect on psoriatic arthritis-related domains: insights from the SPIRIT-H2H study at weeks 24 and 52

Frank Behrens,Celine El Baou,Georg Schett,Filip Van Den Bosch,Christophe Sapin,Soyi Liu Leage,Laure Gossec,Inmaculada De La Torre,Bernard Combe,Gabriella Meszaros

doi:10.1007/s10067-021-05891-5

Abstract

IntroductionImprovements in both musculoskeletal and non-musculoskeletal manifestations are important treatment goals in psoriatic arthritis (PsA).ObjectiveThese post hoc analyses determined whether additional benefits related to various PsA domains are observed in patients simultaneously achieving 50% improvement in American College of Rheumatology criteria (ACR50) and 100% improvement in Psoriasis Area Severity Index (PASI100), the primary endpoint of the SPIRIT-H2H study.MethodsPatients with active PsA and psoriasis in SPIRIT-H2H (N = 566) were categorised into two sets of four response groups irrespective of treatment allocation (approved dosages of ixekizumab or adalimumab): patients who simultaneously achieved ACR50 and PASI100 response, achieved ACR50 response only, achieved PASI100 response only, or did not achieve ACR50 or PASI100 response after 24 and 52 weeks of treatment. Patients achieving simultaneous ACR50 and PASI100 response were compared with the other patient response groups at the corresponding time point for efficacy and health-related quality of life (HRQoL) outcomes.ResultsPatients simultaneously achieving ACR50 and PASI100 responses at week 24 or 52 showed higher rates of ACR70 response, minimal disease activity, Disease Activity in Psoriatic Arthritis ≤ 4, resolution of enthesitis and dactylitis, and HRQoL improvement at weeks 24 and 52, respectively, than the other corresponding response groups at both time points.ConclusionHigh levels of disease control, such as those obtained with simultaneous achievement of ACR50 and PASI100 response, were linked to better outcomes across a wide range of endpoints that are important for patients with PsA. Patients meeting this combined endpoint showed more comprehensive and thus greater control of disease activity.Trial registrationNCT03151551Key Points• Treatment goals for patients with psoriatic arthritis emphasise the importance of improving both musculoskeletal and non-musculoskeletal manifestations of the disease.• A combined endpoint considering both these manifestations, achievement of at least 50% improvement in American College of Rheumatology criteria and 100% improvement in Psoriasis Area Severity Index, was linked with achievement of a number of other endpoints relevant to psoriatic arthritis, including health-related quality of life that are important to patients with psoriatic arthritis.• Patients meeting the combined endpoint were more likely to achieve a disease state of remission, which is the stated aim of treatment for psoriasis.

Highlights

Improvements in both musculoskeletal and non-musculoskeletal manifestations are important treatment goals in psoriatic arthritis (PsA)
JR24 had the highest scores of all the response groups for many baseline musculoskeletal-related variables, such as tender and swollen joint counts, and Disease Activity in Psoriatic Arthritis (DAPSA), enthesitis, dactylitis, HAQ-DI and modified Composite Psoriatic Disease Activity Index scores
ACR20/50/70, improvement of ≥ 20%/50%/70% in American College of Rheumatology criteria; CR24/52, combined responder at week 24/52; DAPSA, Disease Activity for Psoriatic Arthritis; DLQI, Dermatology Life Quality Index; HAQ-DI, Health Assessment Questionnaire-Disability Index; JR24/52, joint responder at week 24/52; LDI-B, Leeds Dactylitis Index-Basic; LEI, Leeds Enthesitis Index; LS, least squares; MCID, minimal clinically important difference; MCS, mental component score; NAPSI, Nail Psoriasis Severity Index; NR24/52, non-responder at week 24/52; PASI75/90/100, ≥ 75%/90%/100% improvement in Psoriasis Area Severity Index score; PCS, physical component score; SD, standard deviation; SE, standard error; SF-36, 36-Item Short Form Survey; SPARCC,Spondyloarthritis Research Consortium of Canada; SR24/52, skin responder at week 24/52; *p < 0.05, **p ≤ 0.001 versus ACR50 plus PASI100 response group

Summary

Introduction

Improvements in both musculoskeletal and non-musculoskeletal manifestations are important treatment goals in psoriatic arthritis (PsA). The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA), the European League Against Rheumatism (EULAR), and the American College of Rheumatology (ACR)/National Psoriasis Foundation share common treatment goals for patients with PsA: to improve health-related quality of life (HRQoL); achieve robust improvement of musculoskeletal manifestations; prevent structural damage; and control non-musculoskeletal manifestations, including skin disease [2,3,4]. Kavanaugh et al [5] confirmed that improvement in both joint and skin manifestations is necessary to optimise improvement in HRQoL For this reason, a combination of two validated outcome measures (≥ 50% improvement in ACR criteria [ACR50] and 100% improvement in Psoriasis Area Severity Index score [PASI100]) was defined as the primary endpoint in the phase IIIb/IV 52-week head-tohead SPIRIT-H2H trial (NCT03151551) of the interleukin (IL)-17A antagonist ixekizumab and the tumour necrosis factor (TNF) inhibitor adalimumab [6]. Ixekizumab is a high-affinity monoclonal antibody that selectively targets IL-17A; it is approved in the USA and European Union for the treatment of moderate-to-severe plaque psoriasis (PsO) in adults and children aged ≥ 6 years and PsA and axial spondyloarthritis in adults [7, 8]

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