PT  - JOURNAL ARTICLE
AU  - Bayat, Sara
AU  - Tascilar, Koray
AU  - Bohr, Daniela
AU  - Krönke, Gerhard
AU  - Simon, David
AU  - Knitza, Johannes
AU  - Hartmann, Fabian
AU  - Schett, Georg
AU  - Kleyer, Arnd
TI  - Efficacy and drug persistence of baricitinib monotherapy is similar to combination therapy in patients with active RA: a prospective observational study
AID  - 10.1136/rmdopen-2022-002674
DP  - 2022 Nov 01
TA  - RMD Open
PG  - e002674
VI  - 8
IP  - 2
4099  - http://rmdopen.bmj.com/content/8/2/e002674.short
4100  - http://rmdopen.bmj.com/content/8/2/e002674.full
SO  - RMD Open2022 Nov 01; 8
AB  - Background Baricitinib (BARI) is approved for the treatment of rheumatoid arthritis (RA) after failure of conventional synthetic and biologic disease modifying anti-rheumatic drugs (cs/bDMARDs) in combination with methotrexate (MTX) or as monotherapy. However, real-world data are scarce regarding efficacy and drug persistence for BARI monotherapy (BARI-mono) versus its combination with MTX (BARI-combo).Objective To evaluate efficacy and drug persistence of BARImono compared with BARI-combo in routine clinical practiceMethods Patients with RA who were switched to BARI were included in a prospective, monocentric cohort. Demographics, clinical outcomes, adverse events and medication were prospectively recorded every 3 months. Clinical efficacy was measured by DAS-28 ESR while drug persistence was measured as the time on drug. We estimated least-square mean DAS-28 scores over time using linear mixed effects models including time-group interactions. Kaplan-Meier method was used to estimate BARI survival and probability of remission over time.Results 139 patients (98 women; aged 58.4 (12.8) years; mean disease duration of 9.7 years) were included between 2017 and 2021. 46 patients received BARI-combo, 93 patients received BARI-mono. Mean DAS-28 ESR were not significantly but only numerically different between both groups at baseline and multiple timepoints over follow-up. DAS-28 ESR remission was attained at least once upto 48 weeks in 62% and 51% patients in BARI-combo versus BARI-mono group (log-rank p=0.64). Drug persistence was high (69 vs 67% at 48 weeks and 62% vs 56% at 96 weeks) and similar in BARI-combo-treated and BARI-mono-treated patients. b/ts DMARD naïve patients had lower mean DAS-28 scores over the follow-up and attained DAS-28 ESR remission earlier than patients with inadequate response to b/ts DMARDs (p=0.11). BARI was discontinued in 11/139 patients (7.9%) due to adverse effects.Conclusion In routine practice, BARI is effective as monotherapy in case of MTX intolerance with overall high drug persistence rates. No new safety signals were observed.Data are available upon reasonable request.