Efficacy and drug persistence of baricitinib monotherapy is similar to combination therapy in patients with active RA: a prospective observational study

Abstract

BackgroundBaricitinib (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).ObjectiveTo evaluate efficacy and drug persistence of BARImono compared with BARI-combo in routine clinical practiceMethodsPatients 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.Results139 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.ConclusionIn routine practice, BARI is effective as monotherapy in case of MTX intolerance with overall high drug persistence rates. No new safety signals were observed.

Comparative Effectiveness of First‐Line Baricitinib in Patients With Rheumatoid Arthritis in the Australian OPAL Data Set

“…A small study from Spain has reported longer treatment persistence for first-line BARI compared with first-line TNFi (23). Other real-world data have also shown similar persistence for BARI monotherapy compared with BARI combination therapy (13). Finally, our findings are also compatible with real-world studies showing similar or slightly longer persistence for JAKi compared with TNFi (9)(10)(11).…”

“…Data from a nationwide Swedish register have shown that patients on BARI have a similar or improved treatment response compared with TNFi or non‐TNFi biologic DMARDs (bDMARDs) ( 12 ). One single‐center study from Germany has shown similar drug persistence for BARI monotherapy compared with BARI received in combination with a conventional synthetic DMARD (csDMARD) ( 13 ).…”

A JAK Inhibitor for Treatment of Rheumatoid Arthritis: The Baricitinib Experience

“…Below is a comprehensive descriptive review of the literature regarding RWE for baricitinib that has been reported to date; data were sourced from registries, monocentric and multicentric clinical practice studies, administrative or insurance claim databases, or prospective observational studies. At the time of writing, 41 published sources for RWE of baricitinib in the treatment of RA were identified [ 29 , 33 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 , 72 , 73 , 74 , 75 , 76 , 77 , 78 , 79 , 80 , 81 , 82 , 83 , 84 , 85 , 86 , 87 , 88 , 89 , 90 , 91 , 92 , 93 , 94 , 95 , 96 , 97 , 98 ].…”

“…Supplementary Table S1 summarises available baseline characteristics of baricitinib-treated patients in real-world settings [ 29 , 33 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 , 72 , 73 , 74 , 75 , 76 , 77 , 78 , 79 , 80 , 81 , 82 , 83 , 84 , 85 , 86 , 87 , 88 , 89 , 90 , 91 , 92 , 93 , 94 , 95 , 96 , 97 , 98 ]. The typical patient in the various RWE sources is aged about 60 years (which is older than the mean age of patients in baricitinib RCTs).…”

A Review of Baricitinib: The Efficacy and Safety in Rheumatic Diseases

“…In a 9.3-year study comparing baricitinib treatment as monotherapy or along with MTX, there was no difference in drug continuation at week 96 between monotherapy (62%) or MTX combination (56%). In this study, it was reported that 30.1% of patients were discontinued due to ineffectiveness and 8.6% due to side effects (14). In a study including 19 different country databases, JAKi users (41% baricitinib, 59% tofacitinib) were less likely to discontinue due to ineffectiveness and more likely to discontinue due to side effects compared with tumor necrosis factor inhibitor users (15).…”