gms | German Medical Science

Introduction: A prospective, observational European study of filgotinib for the treatment of RA in a real-world setting is ongoing. We report baseline characteristics and up to 6-month effectiveness and safety data from the German cohort.

Methods: In the FILOSOPHY study (NCT04871919), patients with RA are treated with filgotinib for the first time in daily practice. We assessed Disease Activity Score in 28 joints–C-reactive protein (DAS28-CRP) and the proportion of patients with a minimal clinically important difference (MCID) from baseline in pain (≤–10 mm; visual analog scale [VAS]) and fatigue (≥4.0; Functional Assessment of Chronic Illness Therapy–Fatigue [FACIT-Fatigue] scale). The incidence of adverse events was assessed in patients ≥65 years old and/or with ≥1 cardiovascular risk factor, and those aged <65 years without cardiovascular risk factors.

Results: As of 30 June 2022, 242 patients had been treated. Mean (standard deviation) age was 57.3 (10.9) years; 75.2% were female (Table 1 [Tab. 1]). Most patients (92.1%) received filgotinib 200 mg. 65.7% received filgotinib monotherapy (with/without glucocorticoids); 33.1% received filgotinib plus conventional synthetic disease-modifying antirheumatic drugs (csDMARDs). 92.1%, 50.8% and 19.8% had received prior csDMARDs, biologic DMARDs or targeted synthetic DMARDs, respectively. DAS28-CRP improved over time (Figure 1 [Fig. 1]); at Month 6, 58.3% achieved DAS28-CRP remission. An MCID in VAS pain and FACIT-Fatigue was achieved by 42.7% and 47.4% of patients, respectively, at Week 1 and 73.2% and 56.5% of patients, respectively, at Month 3. Of 185 patients aged ≥65 years and/or with ≥1 cardiovascular risk factor, 31 (16.8%) had infections (9.2% COVID-19; 0.5% herpes zoster) and 2 (1.1%) had cardiac disorders (angina pectoris and tachycardia); there were no malignancies. Of 57 patients aged <65 years without cardiovascular risk factors, 11 (19.3%) had infections (10.5% COVID-19; 3.5% herpes zoster) and 1 had malignancy (myeloproliferative neoplasm); no cardiac disorders occurred.

Conclusion: Interim 6-month data from the German cohort of FILOSOPHY indicate rapid improvement with filgotinib as early as Week 1 for pain and fatigue and Month 1 for disease activity. Results suggest filgotinib is similarly effective as monotherapy or with csDMARDs; however, no formal testing was applied. No unexpected safety signals or deaths occurred. Long-term follow-up is needed to further evaluate disease outcomes and safety.

Disclosure: The study is funded by Galapagos NV (Mechelen, Belgium). We thank the physicians and patients who participated in the study. Writing support was provided by Debbie Sherwood, BSc, CMPP (Aspire Scientific, Bollington, UK), and funded by Galapagos NV. Publication coordination was provided by Jo-Ann E. West, MSc, a consultant funded by Galapagos NV.

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

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.

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.

Ouafia Bouzid is a consultant employee of Galapagos.?

Thomas Debray has received consulting fees from Biogen, Galapagos and Gilead.

Francesco De Leonardis and Daniel Nagel are employees of Galapagos.

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 Ingelheim, Galapagos, Hexal, Janssen, Lilly, Medac, MSD, Novartis, Pfizer, Roche, Sanofi-Aventis and UCB.

Michael Fiene has received fees for lectures, study activity and congress support from AbbVie, Bristol Myers Squibb, Galapagos, Novartis, Pfizer and UCB.

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