gms | German Medical Science

Introduction: A prospective, observational study (FILOSOPHY; NCT04871919) of filgotinib, a preferential Janus kinase 1 inhibitor for the treatment of RA, in a real-world setting is ongoing in Europe. We aimed to assess baseline characteristics, effectiveness, PROs and safety data for patients treated for up to 18 months in Germany.

Methods: FILOSOPHY will enroll 1,500 advanced therapy (AT)-naïve and AT-experienced patients with RA prescribed filgotinib for the first time in daily practice. Disease activity was measured by Disease Activity Score in 28 joints using C-reactive protein (DAS28-CRP) and Clinical Disease Activity Index (CDAI) at Months 1, 3, 6, 12 and 18. The following PROs were assessed weekly up to Month 1, at Month 3 and then every 3 months up to Month 18: visual analog scale (VAS) pain, Functional Assessment of Chronic Illness Therapy (FACIT)–Fatigue and the Work Productivity and Activity Impairment (WPAI)-RA questionnaire. Treatment-emergent adverse events (TEAEs) on study were recorded.

Results: From May 2021 to July 2023, 465 patients in Germany had initiated filgotinib treatment (median follow-up: 361 days); baseline characteristics are shown in the Table 1 [Tab. 1]. Improvements in DAS28-CRP were seen from Month 1 and were maintained up to Month 18 in AT-naïve and AT-experienced subgroups (Figure A [Fig. 1]). At Month 18, 77.7% of patients had CDAI scores of ≤10 (Figure B [Fig. 1]).

Median (interquartile range [IQR]) VAS pain improved from 60.0 (43.0–75.0) mm at baseline (n=183) to 52.0 (31.0–68.0) mm at Week 1 (n=302), 33.0 (14.0–55.0) mm at Month 1 (n=289) and 23.0 (5.0–39.0) mm at Month 18 (n=91). Median (IQR) FACIT-Fatigue score improved from 26.5 (18.5–35.5) at baseline (n=180) to 30.0 (22.0–40.0) at Week 1 (n=303), 35.0 (26.0–43.0) at Month 1 (n=288) and 37.0 (27.0–43.5) at Month 18 (n=92).

Improvements in WPAI-RA scores were seen as early as Week 1 and were sustained until Month 18 (Figure C [Fig. 1]).

248 patients reported TEAEs on study, which were serious in 47 patients. Adverse events led to treatment discontinuation in 39 patients. The two reported deaths (colon cancer and unknown cause) were considered unrelated to study treatment.

Conclusion: Interim data from patients treated with filgotinib in Germany showed rapid improvements in DAS28-CRP, CDAI and PROs such as pain, fatigue and WPAI-RA scores, which were maintained up to Month 18.

Acknowledgments: We thank the physicians and patients who participated in this study.

The study was funded by Galapagos NV (Mechelen, Belgium). Medical writing support was provided by Debbie Sherwood, BSc, CMPP (Aspire Scientific, Bollington, UK), and funded by Alfasigma SpA. Publication coordination was provided by Jo-Ann Elicia West, MSc (SARL KerWestPen Consulting, Cartigny l’Épinay, France), and funded by Alfasigma SpA.

Disclosures: IA has received consulting fees from Amgen, Boehringer Ingelheim, Chugai, Galapagos, Lilly, Novartis, Pfizer, Sobi, Takeda and UCB; has lectured for AbbVie, Chugai, Gilead, Lilly, MSD, Novartis, Pfizer and UCB; and has received research funding from Lilly.

LB has received fees for consultancy and lectures or study activities, or reimbursement for travel expenses/conference fees, from AbbVie, AstraZeneca, BMS, Boehringer Ingelheim, Galapagos, GSK, Janssen-Cilag, Lilly, Novartis, Roche and UCB.

TK is a shareholder in Novo Nordisk.

OB is a consultant employee of Alfasigma.

TPAD provides consulting services to Alfasigma and has received consultancy fees from Biogen, Daiichi Sankyo, Galapagos and Gilead.

MR is an employee of Alfasigma.

MS has received fees for consultancy and lectures or study activities, or reimbursement for travel expenses/conference fees, from AbbVie, Amgen, Biogen, BMS, Boehringer Ingelheim, Celltrion, Galapagos, Hexal, Janssen, Lilly, Medac, MSD, Novartis, Pfizer, Roche, Sanofi-Aventis and UCB.

GRB has received consultancy fees and speaker fees from AbbVie, BMS, Lilly, Galapagos, MSD and Pfizer.