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Published in: Clinical Rheumatology 12/2021

01-12-2021 | Adalimumab | Original Article

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

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

Published in: Clinical Rheumatology | Issue 12/2021

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Abstract

Introduction

Improvements in both musculoskeletal and non-musculoskeletal manifestations are important treatment goals in psoriatic arthritis (PsA).

Objective

These 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.

Methods

Patients 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.

Results

Patients 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.

Conclusion

High 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 registration
NCT03151551
Key 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.
Appendix
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Literature
5.
6.
go back to reference Mease PJ, Smolen JS, Behrens F, Nash P, Leage SL, Li L, Tahir H, Gooderham M, Krishnan E, Liu-Seifert H, Emery P, Pillai SG, Helliwell PS, SPIRIT H2H study group (2020) A head-to-head comparison of the efficacy and safety of ixekizumab and adalimumab in biological-naïve patients with active psoriatic arthritis: 24-week results of a randomised, open-label, blinded-assessor trial. Ann Rheum Dis 79:123–131. https://doi.org/10.1136/annrheumdis-2019-215386CrossRefPubMed Mease PJ, Smolen JS, Behrens F, Nash P, Leage SL, Li L, Tahir H, Gooderham M, Krishnan E, Liu-Seifert H, Emery P, Pillai SG, Helliwell PS, SPIRIT H2H study group (2020) A head-to-head comparison of the efficacy and safety of ixekizumab and adalimumab in biological-naïve patients with active psoriatic arthritis: 24-week results of a randomised, open-label, blinded-assessor trial. Ann Rheum Dis 79:123–131. https://​doi.​org/​10.​1136/​annrheumdis-2019-215386CrossRefPubMed
9.
go back to reference Smolen JS, Mease P, Tahir H, Schulze-Koops H, de la Torre I, Li L, Hojnik M, Sapin C, Okada M, Caporali R, Grataćos J, Goupille P, Leage SL, Pillai S, Nash P (2020) Multicentre, randomised, open-label, parallel-group study evaluating the efficacy and safety of ixekizumab versus adalimumab in patients with psoriatic arthritis naïve to biological disease-modifying antirheumatic drug: final results by week 52. Ann Rheum Dis 79:1310–1319. https://doi.org/10.1136/annrheumdis-2020-217372CrossRefPubMed Smolen JS, Mease P, Tahir H, Schulze-Koops H, de la Torre I, Li L, Hojnik M, Sapin C, Okada M, Caporali R, Grataćos J, Goupille P, Leage SL, Pillai S, Nash P (2020) Multicentre, randomised, open-label, parallel-group study evaluating the efficacy and safety of ixekizumab versus adalimumab in patients with psoriatic arthritis naïve to biological disease-modifying antirheumatic drug: final results by week 52. Ann Rheum Dis 79:1310–1319. https://​doi.​org/​10.​1136/​annrheumdis-2020-217372CrossRefPubMed
10.
go back to reference Eder L, Chandran V, Gladman DD (2012) Gender-related differences in patients with psoriatic arthritis. Int J Clin Rheumatol 7:641–649CrossRef Eder L, Chandran V, Gladman DD (2012) Gender-related differences in patients with psoriatic arthritis. Int J Clin Rheumatol 7:641–649CrossRef
11.
go back to reference Orbai AM, Perin J, Gorlier C, Coates LC, Kiltz U, Leung YY, Palominos PE, Cañete JD, Scrivo R, Balanescu A, Dernis E, Tälli S, Ruyssen-Witrand A, Soubrier M, Aydin S, Eder L, Gaydukova I, Lubrano E, Kalyoncu U, Richette P, Husni ME, Smolen JS, de Wit M, Gossec L (2020) Determinants of patient-reported psoriatic arthritis impact of disease: an analysis of the association with sex in 458 patients from fourteen countries. Arthritis Care Res (Hoboken) 72:1772–1779. https://doi.org/10.1002/acr.24090CrossRef Orbai AM, Perin J, Gorlier C, Coates LC, Kiltz U, Leung YY, Palominos PE, Cañete JD, Scrivo R, Balanescu A, Dernis E, Tälli S, Ruyssen-Witrand A, Soubrier M, Aydin S, Eder L, Gaydukova I, Lubrano E, Kalyoncu U, Richette P, Husni ME, Smolen JS, de Wit M, Gossec L (2020) Determinants of patient-reported psoriatic arthritis impact of disease: an analysis of the association with sex in 458 patients from fourteen countries. Arthritis Care Res (Hoboken) 72:1772–1779. https://​doi.​org/​10.​1002/​acr.​24090CrossRef
12.
go back to reference van der Horst-Bruinsma I, Nurmohamed M, Van Kuijk A, Siebert S, Bergmans P, De Vlam K, Gremese E, Joven-Ibáñez B, Korotaeva T, Noel W, Sfikakis P, Theander E, Smolen JS, Gossec L (2021) Female versus male burden of psoriatic arthritis is higher and treatment persistence shorter after ustekinumab or tumour necrosis factor inhibitor treatment: 1-year data from the PSABIO Study (abstract OP0232). Ann Rheum Dis 80(Suppl 1):142CrossRef van der Horst-Bruinsma I, Nurmohamed M, Van Kuijk A, Siebert S, Bergmans P, De Vlam K, Gremese E, Joven-Ibáñez B, Korotaeva T, Noel W, Sfikakis P, Theander E, Smolen JS, Gossec L (2021) Female versus male burden of psoriatic arthritis is higher and treatment persistence shorter after ustekinumab or tumour necrosis factor inhibitor treatment: 1-year data from the PSABIO Study (abstract OP0232). Ann Rheum Dis 80(Suppl 1):142CrossRef
13.
go back to reference Mease PJ (2011) Measures of psoriatic arthritis: Tender and Swollen Joint Assessment, Psoriasis Area and Severity Index (PASI), Nail Psoriasis Severity Index (NAPSI), Modified Nail Psoriasis Severity Index (mNAPSI), Mander/Newcastle Enthesitis Index (MEI), Leeds Enthesitis Index (LEI), Spondyloarthritis Research Consortium of Canada (SPARCC), Maastricht Ankylosing Spondylitis Enthesis Score (MASES), Leeds Dactylitis Index (LDI), Patient Global for Psoriatic Arthritis, Dermatology Life Quality Index (DLQI), Psoriatic Arthritis Quality of Life (PsAQOL), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Psoriatic Arthritis Response Criteria (PsARC), Psoriatic Arthritis Joint Activity Index (PsAJAI), Disease Activity in Psoriatic Arthritis (DAPSA), and Composite Psoriatic Disease Activity Index (CPDAI). Arthritis Care Res (Hoboken) 63(Suppl 11):S64–S85CrossRef Mease PJ (2011) Measures of psoriatic arthritis: Tender and Swollen Joint Assessment, Psoriasis Area and Severity Index (PASI), Nail Psoriasis Severity Index (NAPSI), Modified Nail Psoriasis Severity Index (mNAPSI), Mander/Newcastle Enthesitis Index (MEI), Leeds Enthesitis Index (LEI), Spondyloarthritis Research Consortium of Canada (SPARCC), Maastricht Ankylosing Spondylitis Enthesis Score (MASES), Leeds Dactylitis Index (LDI), Patient Global for Psoriatic Arthritis, Dermatology Life Quality Index (DLQI), Psoriatic Arthritis Quality of Life (PsAQOL), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Psoriatic Arthritis Response Criteria (PsARC), Psoriatic Arthritis Joint Activity Index (PsAJAI), Disease Activity in Psoriatic Arthritis (DAPSA), and Composite Psoriatic Disease Activity Index (CPDAI). Arthritis Care Res (Hoboken) 63(Suppl 11):S64–S85CrossRef
Metadata
Title
Measuring treatment effect on psoriatic arthritis-related domains: insights from the SPIRIT-H2H study at weeks 24 and 52
Authors
Frank Behrens
Soyi Liu Leage
Christophe Sapin
Celine El Baou
Inmaculada De La Torre
Gabriella Meszaros
Georg Schett
Bernard Combe
Filip van den Bosch
Laure Gossec
Publication date
01-12-2021
Publisher
Springer International Publishing
Published in
Clinical Rheumatology / Issue 12/2021
Print ISSN: 0770-3198
Electronic ISSN: 1434-9949
DOI
https://doi.org/10.1007/s10067-021-05891-5

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