BackgroundRandomized controlled trials have demonstrated the efficacy and safety of FIL for moderate to severe RA;[1–3] however, real-world evidence is lacking.ObjectivesTo evaluate the rationale for starting FIL in patients (pts) with moderate to severe RA in Germany. Secondary objectives were to describe pt characteristics, concomitant use of glucocorticoids (GCs) and/or methotrexate (MTX), and prior treatment with disease-modifying antirheumatic drugs (DMARDs). Disease activity was an exploratory objective.MethodsThis multicenter retrospective chart review included pts aged ≥18 years with confirmed moderate to severe RA, who initiated FIL before 1 December 2021, with medical records available for ≥6 months prior to initiating FIL (index date) or since initial diagnosis. Data were collected using electronic case report forms; collection was completed on 2 May 2022. Reasons for starting FIL were recorded at index, based on pre-set response categories. Disease activity was assessed in pts with available data using the Clinical Disease Activity Index and Disease Activity Score for 28 joints with C-reactive protein, 3 and 6 months after the index date. Discontinuation of FIL (including reasons) was assessed during the available follow-up of 12 months.ResultsThis study included 301 pts with RA from 20 practices across Germany. Selected baseline pt characteristics and comorbidities are summarized (Table 1). Overall, pts had previously been treated with conventional synthetic (cs) DMARDs (n=282, 93.7%), GCs (n=241, 80.1%), biologic (b) DMARDs (n=199, 66.1%), and targeted synthetic (ts) DMARDs (n=113, 37.6%). One, two, and ≥3 prior advanced DMARDs were received by 87 (28.9%), 51 (16.9%), and 90 (29.9%) pts, respectively; 73 pts (24.3%) were advanced DMARD-naïve. Last treatments before initiating FIL included csDMARDs (n=120, 43.0%), bDMARDs (n=97, 34.8%), GCs (n=88, 31.5%), and tsDMARDS (n=63, 22.6%). Most pts received FIL as monotherapy (n=220, 73.1%); pts received FIL + GCs (n=32, 10.6%), FIL + MTX (n=26, 8.6%), and FIL + MTX + GCs (n=23, 7.6%). Reasons for initiating FIL included oral administration (n=236, 78.4%), fast onset of action (n=201, 66.8%), administration as monotherapy (n=197, 65.4%), good controllability (n=176, 58.5%), good benefit/risk ratio (n=155, 51.5%), low potential for drug-drug interactions (n=97, 32.2%), dosage adjustment in elderly pts (n=35, 11.6%), lower risk of herpes zoster (n=45, 15.0%), and inefficacy of previous therapies (n=10, 3.3%). Disease activity during the follow-up is shown (Figure 1). In total, 43 pts (14.3%) discontinued FIL during the follow-up because of: lack of efficacy (n=26, 8.6%), intolerance or adverse drug reaction (n=12, 4.0%), lack of drug adherence (n=4, 1.3%), and remission (n=1, 0.3%).ConclusionIn this real-world setting in Germany, reasons for initiating FIL were related to general Janus kinase inhibitor, as well as FIL-specific, attributes. Most pts received FIL as monotherapy. FIL was effective and generally well tolerated; however, longer-term data are needed.
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