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Impact of tocilizumab monotherapy on patient-reported outcomes in patients with rheumatoid arthritis from two randomised controlled trials

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Strand V1, Michalska M2, Birchwood C2, Pei J2, Tuckwell K3, Finch R4, Gabay C5, Kavanaugh A6, Jones G7. RMD Open. 2017 Sep 14;3(2):e000496. doi: 10.1136/rmdopen-2017-000496. eCollection 2017.

Abstract

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1 Division of Immunology and Rheumatology, Stanford University School of Medicine, Palo Alto, California, USA.

2 US Medical Affairs, Immunology, Genentech, Inc., South San Francisco, California, USA.

3 gRED Early Clinical Development, OMNI, Genentech, Inc., South San Francisco, California, USA.

4 PDBB-Biostatistics, Roche, Welwyn Garden City, UK.

5 Division of Rheumatology, Geneva University Hospitals, Geneva, Switzerland.

6 Division of Rheumatology, Allergy and Immunology, University of California San Diego, La Jolla, California, USA.

7 Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.

Abstract

OBJECTIVE: Two randomised controlled trials, AMBITION (NCT00109408) and ADACTA (NCT01119859), showed tocilizumab (TCZ) monotherapy superior to methotrexate (MTX) and adalimumab (ADA) monotherapy, respectively, for improving rheumatoid arthritis (RA) disease activity. This study compared the benefit of TCZ versus MTX or ADA monotherapy for improving patient-reported outcomes (PROs) in patients with RA.

METHODS: PROs included patient global assessment (PtGA), pain, Health Assessment Questionnaire Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue and Short Form-36 (SF-36) physical component summary (PCS) and mental component summary (MCS) and eight domain scores. Outcomes included proportions of patients reporting changes from baseline in PRO scores ≥minimum clinically important differences (MCID) and ≥age-matched and gender-matched normative values at 24 weeks.

RESULTS: In AMBITION, TCZ-treated patients reported significantly greater mean improvements in HAQ (-0.7 vs -0.5), FACIT-Fatigue (8.7 vs 5.7), SF-36 PCS (9.8 vs 7.8) and five SF-36 domains at week 24 than with MTX; 45.0%-84.0% of TCZ-treated patients reported improvements ≥MCID, and 24.3%-52.1% reported scores ≥normative values across all PROs versus 39.4%-81.8% and 14.5%-45.0%, respectively, with MTX. In ADACTA, TCZ-treated patients reported significantly greater improvements in PtGA (-42.3 vs -31.8), pain (-40.1 vs -28.7), SF-36 MCS (7.9 vs 5.0) and three SF-36 domains than with ADA; 57.7%-83.3% of TCZ-treated patients reported improvements ≥MCID, and 22.1%-49.3% reported scores ≥normative values across all PROs versus 13.6%-37.8%, respectively, with ADA.

CONCLUSIONS: TCZ monotherapy resulted in more patients reporting clinically meaningful PRO improvements and PRO scores ≥normative values compared with MTX or ADA monotherapy.

TRIAL REGISTRATION NUMBERS: NCT00109408 and NCT01119859; Post-results.