Etanercept is effective as monotherapy or in combination with methotrexate in rheumatoid arthritis: subanalysis of an observational study
Approximately 30% of patients with rheumatoid arthritis receiving biological disease-modifying antirheumatic drugs (bDMARDs) take them as monotherapy. Although etanercept (ETN) monotherapy has been evaluated in clinical trials, data in the real-world setting are sparse. We compared the efficacy and...
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Published in | Clinical rheumatology Vol. 36; no. 9; pp. 1989 - 1996 |
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Main Authors | , , , , , |
Format | Journal Article |
Language | English |
Published |
London
Springer London
01.09.2017
Springer Nature B.V |
Subjects | |
Online Access | Get full text |
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Summary: | Approximately 30% of patients with rheumatoid arthritis receiving biological disease-modifying antirheumatic drugs (bDMARDs) take them as monotherapy. Although etanercept (ETN) monotherapy has been evaluated in clinical trials, data in the real-world setting are sparse. We compared the efficacy and safety of ETN, given alone or in combination with methotrexate (MTX), in routine clinical practice. This was a subanalysis of patients who received either ETN alone or ETN + MTX during a 52-week prospective, observational study conducted at 329 German centers. The primary endpoint was “Funktionsfragebogen Hannover” (Hannover Functional Ability Questionnaire [FFbH]; low FFbH = worse function) functional remission at week 26 and week 52. Secondary endpoints included the 28-joint count Disease Activity Score (DAS28), DAS28 remission (DAS28 < 2.6), and adverse events (AEs). Participating centers applied ETN monotherapy in 43.1% of patients and ETN + MTX in 56.9%. A smaller proportion of patients achieved FFbH functional remission with ETN vs ETN + MTX (31.9%, 95% confidence interval [CI] 29.1–34.9% vs 39.8%, 37.2–42.5%, respectively;
p
< 0.001) at 26 weeks and at 52 weeks (38.4%, 35.1–41.7% vs 44.3%, 41.5–47.2%, respectively;
p
= 0.007). After 52 weeks, the mean DAS28 (±SD) decreased from 5.5 ± 1.3 to 3.4 ± 1.4 (ETN) vs 5.3 ± 1.3 to 3.2 ± 1.3 (ETN + MTX) and DAS28 remission was achieved by 32.5% (95% CI 29.0–36.1%) of patients with ETN vs 38.8% (35.8–41.9%;
p
= 0.007) with ETN + MTX. Overall, 20.6 (ETN) and 19.7% (ETN + MTX) of patients reported treatment-related AEs. Patients received ETN monotherapy almost as often as ETN + MTX. ETN + MTX appeared marginally more effective than ETN monotherapy in some, but not all, outcomes measured. |
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Bibliography: | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-3 content type line 23 ObjectType-Undefined-2 |
ISSN: | 0770-3198 1434-9949 |
DOI: | 10.1007/s10067-017-3757-8 |