Patient-reported outcomes from a randomized phase III trial of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis
Abstract Background The phase III MONARCH randomized controlled trial (NCT02332590) demonstrated that in patients with rheumatoid arthritis (RA), sarilumab (anti-interleukin-6 receptor monoclonal antibody) monotherapy is superior to adalimumab monotherapy in reducing disease activity and signs and s...
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doaj-0f4f3986999d4d779a961f01dcdc58ab2020-11-25T01:33:31ZengBMCArthritis Research & Therapy1478-63622018-06-0120111210.1186/s13075-018-1614-zPatient-reported outcomes from a randomized phase III trial of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritisVibeke Strand0Laure Gossec1Clare W. J. Proudfoot2Chieh-I Chen3Matthew Reaney4Sophie Guillonneau5Toshio Kimura6Janet van Adelsberg7Yong Lin8Erin K. Mangan9Hubert van Hoogstraten10Gerd R. Burmester11Stanford UniversitySorbonne Universités, UPMC Université Paris 6, GRC-UPMC 08 (EEMOIS)SanofiRegeneron Pharmaceuticals, Inc.SanofiSanofiRegeneron Pharmaceuticals, Inc.Regeneron Pharmaceuticals, Inc.SanofiRegeneron Pharmaceuticals, Inc.SanofiCharité - University MedicineAbstract Background The phase III MONARCH randomized controlled trial (NCT02332590) demonstrated that in patients with rheumatoid arthritis (RA), sarilumab (anti-interleukin-6 receptor monoclonal antibody) monotherapy is superior to adalimumab monotherapy in reducing disease activity and signs and symptoms of RA, as well as in improving physical function, with similar rates of adverse and serious adverse events. We report the effects of sarilumab versus adalimumab on patient-reported outcomes (PROs). Methods Patients with active RA intolerant of, or inadequate responders to, methotrexate were randomized to sarilumab 200 mg plus placebo every 2 weeks (q2w; n = 184) or adalimumab 40 mg plus placebo q2w (n = 185). Dose escalation to weekly administration of adalimumab or matching placebo was permitted at week 16. PROs assessed at baseline and weeks 12 and 24 included patient global assessment of disease activity (PtGA), pain and morning stiffness visual analogue scales (VASs), Health Assessment Questionnaire Disability Index (HAQ-DI), 36-item Short Form Health Survey (SF-36), Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F), Rheumatoid Arthritis Impact of Disease (RAID), and rheumatoid arthritis-specific Work Productivity Survey (WPS-RA). Between-group differences in least-squares mean (LSM) changes from baseline were analyzed. p < 0.05 was considered significant for PROs in a predefined hierarchy. For PROs not in the hierarchy, nominal p values are provided. Proportions of patients reporting improvements greater than or equal to the minimal clinically important difference (MCID) and achieving normative values were assessed. Results At week 24, sarilumab treatment resulted in significantly greater LSM changes from baseline than adalimumab monotherapy in HAQ-DI (p < 0.005), PtGA (p < 0.001), pain VAS (p < 0.001), and SF-36 Physical Component Summary (PCS) (p < 0.001). Greater LSM changes were reported for sarilumab than for adalimumab in RAID (nominal p < 0.001), morning stiffness VAS (nominal p < 0.05), and WPS-RA (nominal p < 0.005). Between-group differences in FACIT-F and SF-36 Mental Component Summary (MCS) were not significant. More patients reported improvements greater than or equal to the MCID in HAQ-DI (nominal p < 0.01), RAID (nominal p < 0.01), SF-36 PCS (nominal p < 0.005), and morning stiffness (nominal p < 0.05), as well as greater than or equal to the normative values in HAQ-DI (p < 0.05), with sarilumab versus adalimumab. Conclusions In parallel with the clinical efficacy profile previously reported, sarilumab monotherapy resulted in greater improvements across multiple PROs than adalimumab monotherapy. Trial registration ClinicalTrials.gov, NCT02332590. Registered on 5 January 2015.http://link.springer.com/article/10.1186/s13075-018-1614-zSarilumabAdalimumabBiologic disease-modifying antirheumatic drugsRheumatoid arthritisPatient-reported outcomes |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Vibeke Strand Laure Gossec Clare W. J. Proudfoot Chieh-I Chen Matthew Reaney Sophie Guillonneau Toshio Kimura Janet van Adelsberg Yong Lin Erin K. Mangan Hubert van Hoogstraten Gerd R. Burmester |
spellingShingle |
Vibeke Strand Laure Gossec Clare W. J. Proudfoot Chieh-I Chen Matthew Reaney Sophie Guillonneau Toshio Kimura Janet van Adelsberg Yong Lin Erin K. Mangan Hubert van Hoogstraten Gerd R. Burmester Patient-reported outcomes from a randomized phase III trial of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis Arthritis Research & Therapy Sarilumab Adalimumab Biologic disease-modifying antirheumatic drugs Rheumatoid arthritis Patient-reported outcomes |
author_facet |
Vibeke Strand Laure Gossec Clare W. J. Proudfoot Chieh-I Chen Matthew Reaney Sophie Guillonneau Toshio Kimura Janet van Adelsberg Yong Lin Erin K. Mangan Hubert van Hoogstraten Gerd R. Burmester |
author_sort |
Vibeke Strand |
title |
Patient-reported outcomes from a randomized phase III trial of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis |
title_short |
Patient-reported outcomes from a randomized phase III trial of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis |
title_full |
Patient-reported outcomes from a randomized phase III trial of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis |
title_fullStr |
Patient-reported outcomes from a randomized phase III trial of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis |
title_full_unstemmed |
Patient-reported outcomes from a randomized phase III trial of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis |
title_sort |
patient-reported outcomes from a randomized phase iii trial of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis |
publisher |
BMC |
series |
Arthritis Research & Therapy |
issn |
1478-6362 |
publishDate |
2018-06-01 |
description |
Abstract Background The phase III MONARCH randomized controlled trial (NCT02332590) demonstrated that in patients with rheumatoid arthritis (RA), sarilumab (anti-interleukin-6 receptor monoclonal antibody) monotherapy is superior to adalimumab monotherapy in reducing disease activity and signs and symptoms of RA, as well as in improving physical function, with similar rates of adverse and serious adverse events. We report the effects of sarilumab versus adalimumab on patient-reported outcomes (PROs). Methods Patients with active RA intolerant of, or inadequate responders to, methotrexate were randomized to sarilumab 200 mg plus placebo every 2 weeks (q2w; n = 184) or adalimumab 40 mg plus placebo q2w (n = 185). Dose escalation to weekly administration of adalimumab or matching placebo was permitted at week 16. PROs assessed at baseline and weeks 12 and 24 included patient global assessment of disease activity (PtGA), pain and morning stiffness visual analogue scales (VASs), Health Assessment Questionnaire Disability Index (HAQ-DI), 36-item Short Form Health Survey (SF-36), Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F), Rheumatoid Arthritis Impact of Disease (RAID), and rheumatoid arthritis-specific Work Productivity Survey (WPS-RA). Between-group differences in least-squares mean (LSM) changes from baseline were analyzed. p < 0.05 was considered significant for PROs in a predefined hierarchy. For PROs not in the hierarchy, nominal p values are provided. Proportions of patients reporting improvements greater than or equal to the minimal clinically important difference (MCID) and achieving normative values were assessed. Results At week 24, sarilumab treatment resulted in significantly greater LSM changes from baseline than adalimumab monotherapy in HAQ-DI (p < 0.005), PtGA (p < 0.001), pain VAS (p < 0.001), and SF-36 Physical Component Summary (PCS) (p < 0.001). Greater LSM changes were reported for sarilumab than for adalimumab in RAID (nominal p < 0.001), morning stiffness VAS (nominal p < 0.05), and WPS-RA (nominal p < 0.005). Between-group differences in FACIT-F and SF-36 Mental Component Summary (MCS) were not significant. More patients reported improvements greater than or equal to the MCID in HAQ-DI (nominal p < 0.01), RAID (nominal p < 0.01), SF-36 PCS (nominal p < 0.005), and morning stiffness (nominal p < 0.05), as well as greater than or equal to the normative values in HAQ-DI (p < 0.05), with sarilumab versus adalimumab. Conclusions In parallel with the clinical efficacy profile previously reported, sarilumab monotherapy resulted in greater improvements across multiple PROs than adalimumab monotherapy. Trial registration ClinicalTrials.gov, NCT02332590. Registered on 5 January 2015. |
topic |
Sarilumab Adalimumab Biologic disease-modifying antirheumatic drugs Rheumatoid arthritis Patient-reported outcomes |
url |
http://link.springer.com/article/10.1186/s13075-018-1614-z |
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