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Etanercept is effective as monotherapy or in combination with methotrexate in rheumatoid arthritis: subanalysis of an observational study

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Abstract

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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Acknowledgements

We thank the study investigators, the staff, and the patients for their participation in this trial. Editorial/medical writing support was provided by Neel Misra and Rina Vekaria Passmore of Engage Scientific Solutions and was funded by Pfizer.

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Authors and Affiliations

  1. Interdisziplinäre Diagnostik und Therapie, Akademie für Manuelle Medizin an der WWU Münster, Von-Esmarch-Str. 50, 48149, Münster, Germany

    Markus Gaubitz

  2. Gemeinschaftspraxis, Passau, Germany

    Karl-Heinz Göttl

  3. Pfizer Pharma GmbH, Berlin, Germany

    Olaf Behmer, Ralph Lippe, Thomas Meng & Peter-Andreas Löschmann

Authors
  1. Markus Gaubitz
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  2. Karl-Heinz Göttl
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  3. Olaf Behmer
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  4. Ralph Lippe
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  5. Thomas Meng
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  6. Peter-Andreas Löschmann
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Corresponding author

Correspondence to Markus Gaubitz.

Ethics declarations

This study was approved by the local Ethics Committee of the State Chamber of Physicians and of the University of Muenster, and all patients gave written informed consent. It was conducted in accordance with the Declaration of Helsinki and complied with local German regulations and German Drug Law.

Funding

This observational study was sponsored by Pfizer, which was responsible for collecting and analyzing the data.

Disclosures

Markus Gaubitz received speaker’s honoraria from AbbVie, Amgen, BMS, Boehringer Ingelheim, Chugai, Celgene, Grünenthal, Hexal, Janssen, Medac, MSD, Mundipharma, Pfizer, Roche, Servier, SOBI, and UCB.

Karl-Heinz Göttl declares that he has no conflicts of interest.

Olaf Behmer is an employee of Pfizer Pharma GmbH and has a financial interest in Pfizer.

Ralph Lippe is an employee of Pfizer Pharma GmbH and has a financial interest in Pfizer.

Thomas Meng is an employee of Pfizer Pharma GmbH and has a financial interest in Pfizer.

Peter-Andreas Löschmann is an employee of Pfizer Pharma GmbH and has a financial interest in Pfizer.

Additional information

Trial registration: ClinicalTrials.gov, NCT00488475

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Gaubitz, M., Göttl, KH., Behmer, O. et al. Etanercept is effective as monotherapy or in combination with methotrexate in rheumatoid arthritis: subanalysis of an observational study. Clin Rheumatol 36, 1989–1996 (2017). https://doi.org/10.1007/s10067-017-3757-8

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  • DOI: https://doi.org/10.1007/s10067-017-3757-8

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