Pos0851 real-world experience with filgotinib (fil) for rheumatoid arthritis (ra) in germany: a retrospective chart review

Background Randomized controlled trials have demonstrated the efficacy and safety of FIL for moderate to severe RA; [1–3] however, real-world evidence is lacking. Objectives To 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. Methods This 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. Results This 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%). Conclusion In 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. References [1]Combe B, et al. Ann Rheum Dis 2021;80:848–58. [2]Genovese MC, et al. JAMA 2019;322:315–25. [3]Westhovens R, et al. Ann Rheum Dis 2021;80:727–38. Table 1. Selected baseline patient characteristics and comorbidities Total N=301 Age at index date, mean (SD) 59.2 (12.4) Age groups, n (%) <65 years 202 (67.1) ≥65 to 74 years 62 (20.6) ≥75 years 37 (12.3) Female sex, n (%) 244 (81.1) CDAI, mean (SD) 25.4 (10.9), N=231 DAS28-CRP, mean (SD) 4.8 (1.1), N=230 Disease duration, years, n (%) <1 11 (3.7) 1–5 86 (28.6) 5–10 89 (29.6) >10 115 (38.2) Follow-up, months, mean (SD) 7.9 (4.0) Current/ex-smoker, n (%) 43 (14.3)/46 (15.3) Any cardiovascular risk factor,* n (%) 140 (46.5) Obesity [BMI ≥30 kg/m 2] , n (%) 35 (11.6) Cancer, n (%) 12 (4.0) Inflammatory bowel disease, n (%) 6 (2.0) *Patients may have ≥1 cardiovascular risk factor. BMI, body mass index; CDAI, Clinical Disease Activity Index; DAS28-CRP, Disease Activity Score for 28 joints with C-reactive protein; SD, standard deviation. Acknowledgements We thank the physicians and patients who participated in this study. This study was funded by Galapagos NV (Mechelen, Belgium). Publication coordination was provided by Fabien Debailleul, PhD, of Galapagos NV. Medical writing support was provided by Stephanie Rippon, MBio (Aspire Scientific Ltd, Bollington, UK), and funded by Galapagos NV. Disclosure of Interests Olaf Schultz Speakers bureau: Abbott, BMS, Galapagos, MSD, Novartis, Pfizer, Christoph Fiehn Speakers bureau: AbbVie, AstraZeneca, Boehringer Ingelheim, Celgene, Galapagos, Janssen, Lilly, Medac, MSD, Novartis, Pfizer, Sanofi, UCB, Consultant of: Boehringer Ingelheim, Galapagos, Lilly, Christian Kneitz Speakers bureau: AbbVie, Berlin-Chemie, Biogen, Boehringer Ingelheim, Celgene, Celltrion, Chugai, Galapagos, Gilead, GSK, Janssen, Lilly, Medac, MSD, Novartis, Oxford Immunotec, Pfizer, Roche, Sanofi, Takeda, UCB, Consultant of: AbbVie, Boehringer Ingelheim, Galapagos, Janssen, Novartis, Nils Picker: None declared, Daniel Kromer: None declared, Monia Zignani Shareholder of: Galapagos, Employee of: Galapagos, Francesco De Leonardis Employee of: Galapagos, Hans-Dieter Orzechowski Shareholder of: Gilead Sciences, Employee of: Galapagos Biopharma GmbH Germany, Margot Gurrath Shareholder of: Gilead Sciences, Employee of: Galapagos Biopharma GmbH Germany, Klaus Krueger Speakers bureau: Galapagos, Gilead, Consultant of: Galapagos, Gilead.