PMID- 28756532 OWN - NLM STAT- MEDLINE DCOM- 20180719 LR - 20220331 IS - 1434-9949 (Electronic) IS - 0770-3198 (Linking) VI - 36 IP - 9 DP - 2017 Sep TI - Etanercept is effective as monotherapy or in combination with methotrexate in rheumatoid arthritis: subanalysis of an observational study. PG - 1989-1996 LID - 10.1007/s10067-017-3757-8 [doi] AB - 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. FAU - Gaubitz, Markus AU - Gaubitz M AD - Interdisziplinare Diagnostik und Therapie, Akademie fur Manuelle Medizin an der WWU Munster, Von-Esmarch-Str. 50, 48149, Munster, Germany. gaubitz@uni-muenster.de. FAU - Gottl, Karl-Heinz AU - Gottl KH AD - Gemeinschaftspraxis, Passau, Germany. FAU - Behmer, Olaf AU - Behmer O AD - Pfizer Pharma GmbH, Berlin, Germany. FAU - Lippe, Ralph AU - Lippe R AD - Pfizer Pharma GmbH, Berlin, Germany. FAU - Meng, Thomas AU - Meng T AD - Pfizer Pharma GmbH, Berlin, Germany. FAU - Loschmann, Peter-Andreas AU - Loschmann PA AD - Pfizer Pharma GmbH, Berlin, Germany. LA - eng PT - Journal Article PT - Multicenter Study PT - Observational Study DEP - 20170730 PL - Germany TA - Clin Rheumatol JT - Clinical rheumatology JID - 8211469 RN - 0 (Antirheumatic Agents) RN - 0 (Receptors, Tumor Necrosis Factor) RN - OP401G7OJC (Etanercept) RN - YL5FZ2Y5U1 (Methotrexate) SB - IM MH - Adult MH - Aged MH - Antirheumatic Agents/*therapeutic use MH - Arthritis, Rheumatoid/*drug therapy MH - Drug Therapy, Combination MH - Etanercept/*therapeutic use MH - Female MH - Germany MH - Humans MH - Male MH - Methotrexate/*therapeutic use MH - Middle Aged MH - Prospective Studies MH - Receptors, Tumor Necrosis Factor/antagonists & inhibitors MH - Remission Induction MH - Severity of Illness Index MH - Treatment Outcome OTO - NOTNLM OT - Etanercept OT - Methotrexate OT - Observational study OT - Rheumatoid arthritis OT - Tumor necrosis factor-alpha EDAT- 2017/08/02 06:00 MHDA- 2018/07/20 06:00 CRDT- 2017/07/31 06:00 PHST- 2017/04/28 00:00 [received] PHST- 2017/07/07 00:00 [accepted] PHST- 2017/07/04 00:00 [revised] PHST- 2017/08/02 06:00 [pubmed] PHST- 2018/07/20 06:00 [medline] PHST- 2017/07/31 06:00 [entrez] AID - 10.1007/s10067-017-3757-8 [pii] AID - 10.1007/s10067-017-3757-8 [doi] PST - ppublish SO - Clin Rheumatol. 2017 Sep;36(9):1989-1996. doi: 10.1007/s10067-017-3757-8. Epub 2017 Jul 30.