gms | German Medical Science

Introduction: Filgotinib is approved for the treatment of moderate to severe active rheumatoid arthritis. A phase 4, European, prospective, observational study (NCT04871919) is ongoing. We report baseline characteristics of German patients enrolled.

Methods: This noninterventional European study will enroll approximately 1500 patients aged ≥18 years prescribed filgotinib for the first time. The primary endpoint is treatment persistence rate at 24 months; secondary endpoints include patient-reported outcomes (pain, fatigue, work productivity and activity impairment), medication adherence, and safety. Baseline characteristics reported include demographics and disease characteristics, comorbidities, fatigue score, pain severity, tender/swollen 28-joint count, patient and physician global assessment, Disease Activity Score in 28 joints (DAS28) with C-reactive protein, Clinical Disease Activity Index (CDAI) score, prior and concomitant treatments, and reason for starting filgotinib.

Results: As of 31 December 2021, 98 German patients have been enrolled; information regarding filgotinib treatment is available for 90 patients. Baseline demographics, disease activity measures, laboratory measures, and prior and current treatments are shown in Table 1 [Tab. 1]. Baseline comorbidities included hypertension (30.0%), dyslipidemia (10.0%), type 2 diabetes (4.4%), atrial fibrillation (1.1%), myocardial infarction (1.1%), and history of cancer (1.1%). Of patients who had started filgotinib, 18 (20.0%) were aged ≥65 years and 36 (40.0%) were known former/current smokers. Patients had previously received methotrexate (63.3%), other conventional synthetic disease-modifying antirheumatic drugs (DMARDs) (45.6%), biologic DMARDs (36.7%; 32.2% tumor necrosis factor inhibitors), or targeted synthetic DMARDs (18.9%); 32.2% had previously received glucocorticoids. Most patients (60.0%) received filgotinib monotherapy (21.1% with glucocorticoids); 36.7% received filgotinib in combination with methotrexate (17.8% with glucocorticoids). The median (range) daily dose of oral glucocorticoids at baseline was 5.0 mg (2.0–30.0 mg); one patient received a dose of 250.0 mg by infusion/injection. Filgotinib was started due to inadequate response (51.1%), loss of response (31.1%), or intolerance to previous treatment (5.6%), or other reason (12.2%).

Conclusion: These are the first real-world data reported for filgotinib-treated patients in Germany. At study entry, patients had moderate disease activity and a relatively high proportion of comorbidities. Nearly 40% had received prior biologic DMARDs and nearly 20% prior targeted synthetic DMARDs; 60% initiated filgotinib monotherapy.

Disclosures: The study was funded by Galapagos NV (Mechelen, Belgium).

Gerd Burmester has received honoraria for consulting and lectures from AbbVie, Bristol Myers Squibb, Galapagos, Lilly, MSD, Pfizer, and Roche.

Ioana Andreica has received consulting fees from Amgen, Boehringer Ingelheim Pharma GmbH, Chugai Pharma, Galapagos Biopharma Deutschland GmbH, Lilly, Novartis Pharma, Pfizer Pharma GmbH, Swedish Orphan Biovitrum, Takeda Pharmaceutical, and UCB Pharma; has lectured for AbbVie, Chugai Pharma, Gilead Sciences, Lilly, MSD Sharp & Dohme GmbH, Novartis Pharma, Pfizer Pharma GmbH, Swedish Orphan Biovitrum, and UCB Pharma; and has received research funding from Lilly.

Emilia Gvozdenovic and Monia Zignani are employees of Galapagos. Monia Zignani is a shareholder in Galapagos.

Klaus Krüger has received fees for consultancy and lectures from AbbVie, Amgen, Biogen, Boehringer, Bristol Myers Squibb, Celltrion, Galapagos, Janssen, Lilly, Medac, MSD, Novartis, Pfizer, Roche, Sandoz, Sanofi-Aventis, UCB, and Viatris.

Maren Sieburg has received fees for consultancy and lectures or study activities, or reimbursement for travel expenses/conference fees from Abbvie, Amgen, Biogen, Bristol Myers Squibb, Boehringer-Ingelheimer, Galapagos, Hexal, Janssen, Lilly, Medac, MSD, Novartis, Pfizer, Roche, Sanofi-Aventis, and UCB.

Jan Brandt-Jürgens has received fees for consultancy and clinical trials from AbbVie, Affibody, Bristol Myers Squibb, Gilead, Janssen, Lilly, Medac, MSD, Novartis, Pfizer, Roche, Sanofi-Aventis, and UCB.

Patrizia Maria Sternad declares no disclosures.