AB0689 SUSTAINED PATIENT MEANINGFUL OUTCOMES OF PAIN AND FATIGUE RELIEF AND IMPROVED PHYSICAL FUNCTIONING WITH FILGOTINIB IN RHEUMATOID ARTHRITIS: A POST HOC ANALYSIS
Authors: R. Alten, B. Fautrel, P. G. Conaghan, D. De Vries, M. Faes, M. Piovesan, K. Van Beneden, C. Watson, A. E. A. M. Weel-Koenders, E. Feist, K. De Vlam
Journal: Annals of the Rheumatic Diseases (2024)

<h3>Background:</h3> The quality of life of patients with rheumatoid arthritis (RA) can be severely impacted by pain, fatigue and impaired physical functioning that can vary week-on-week.<sup>1</sup> Filgotinib (FIL) has previously demonstrated early onset of improvement in these meaningful patient-reported outcomes (PROs) at the group level.<sup>2,3</sup> However, it is unknown what proportion of patients improved and whether these improvements are sustained at the individual level. <h3>Objectives:</h3> To assess patient-level sustained improvement in meaningful PROs (pain, fatigue and physical functioning) in patients with RA receiving FIL 200 or 100 mg (FIL200/100), adalimumab (ADA) or placebo (PBO). <h3>Methods:</h3> This <i>post hoc</i> analysis assessed data from the Phase 3 trials FINCH 1 (NCT02889796) and FINCH 2 (NCT02873936). In FINCH 1, patients with an inadequate response (IR) to methotrexate (MTX) received FIL200/100, ADA or PBO, all with MTX, for 52 weeks. In FINCH 2, patients with an IR to ≥1 biologic disease-modifying antirheumatic drug (DMARD) received FIL200/100 or PBO, all with conventional synthetic DMARDs, for 24 weeks. The proportions of patients meeting the following criteria were assessed: "limited to no pain" status (visual analog scale [VAS] ≤10 mm), "health status not negatively affected by pain" (VAS ≤20 mm),<sup>4</sup> Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue (minimal clinically important difference [MCID], change from baseline [CFB] ≥4) and Health Assessment Questionnaire–Disability Index (HAQ-DI) (MCID, CFB = –0.22 or lower). The proportion of patients achieving first response at Week (W)2, W4, W12, W24 and W52 (W52 for FINCH 1 only); duration of response (responders only); and the proportion of patients achieving first response by W12 with sustained response at W24 and W52 (W52 for FINCH 1 only) were reported by treatment arm. The proportions of patients were estimated using nonresponder imputation, and duration of response was analyzed using Kaplan–Meier estimates. <h3>Results:</h3> Overall, compared with those receiving FIL100 or PBO, a greater proportion of patients receiving FIL200 first achieved a response for: "limited to no pain", "health status not negatively affected by pain", FACIT-Fatigue and HAQ-DI in FINCH 1 and FINCH 2, except for FACIT-Fatigue with FIL100, for which the proportions were similar. In FINCH 1, a greater proportion of patients receiving active treatment first achieved "limited to no pain" status than those receiving PBO, and a higher proportion of patients in the FIL200 arm reached these criteria than in the FIL100 or ADA arms (by W4, FIL200: 12.2%, FIL100: 7.1%, ADA: 8.6% vs PBO: 3.6%). The duration of HAQ-DI response in FINCH 1 and FINCH 2 was similar with FIL200 and FIL100, and was longer than that observed with ADA and PBO (Figure 1). A loss of HAQ-DI response was observed up to 12 weeks after first response; after 12 weeks, the response remained stable. A similar pattern was observed for other PRO responses in FINCH 1 and FINCH 2, except for FACIT-Fatigue, for which the FIL and ADA curves overlapped. With FIL200, first "limited to no pain" status was achieved by W12 and sustained to W52 in 15.4% of patients in FINCH 1 (Table 1) and to W24 in 13.6% of patients in FINCH 2. The proportions of patients receiving FIL200 with sustained "health status not negatively affected by pain", FACIT-Fatigue and HAQ-DI responses were 29.7%, 49.3% and 64.4% in FINCH 1 (W52) and 29.9%, 55.8% and 63.9% in FINCH 2 (W24), respectively. <h3>Conclusion:</h3> This <i>post hoc</i> analysis shows that meaningful improvements in PROs (VAS pain, FACIT-Fatigue and HAQ-DI) with FIL in RA at the patient level occur early and are sustained over time. These data help to strengthen the scientific understanding of the unique clinical and PRO benefits with FIL treatment relevant to patients. <h3>REFERENCES:</h3> [1] Alten R, et al. <i>Arthritis Rheumatol</i> 2023;75(Suppl 9):1680 [2] Taylor PC, et al. <i>Arthritis Rheumatol</i> 2023;82(Suppl 1):0290 [3] Bingham CO 3rd, et al. <i>Arthritis Res Ther</i> 2022;24:11 [4] Taylor PC, et al. <i>J Clin Med</i> 2019;8:831 <h3>Acknowledgements:</h3> We thank the physicians and patients who participated in these studies. The FINCH 1 and FINCH 2 studies were funded by Gilead Sciences, Inc. (Foster City, CA, USA). This analysis was funded by Galapagos NV (Mechelen, Belgium). Medical writing support was provided by Stephanie Rippon, MBio (Aspire Scientific, Bollington, UK), and funded by Galapagos NV (Mechelen, Belgium). Publication coordination was provided by Jo-Ann E. West, MSc, a consultant funded by Galapagos NV. <h3>Disclosure of Interests:</h3> Rieke Alten AbbVie, Amgen, Biogen, BMS, Celltrion, Eli Lilly, Gilead, Janssen, Medac, MSD, Mylan, Novartis, Pfizer, Roche, Sandoz, Sanofi-Genzyme, UCB and Viatris, AbbVie, Amgen, Biogen, BMS, Celltrion, Eli Lilly, Gilead, Janssen, Medac, MSD, Mylan, Novartis, Pfizer, Roche, Sandoz, Sanofi-Genzyme, UCB and Viatris, Bruno Fautrel AbbVie, Amgen, Biogen, BMS, Celgene, Celltrion, Chugai, Eli Lilly, Fresenius Kabi, Gilead, Janssen, Medac, MSD, Mylan, Nordic Pharma, Novartis, Pfizer, Roche, Sandoz, Sanofi-Genzyme, Sobi and UCB, AbbVie, Eli Lilly, MSD and Pfizer, Philip G. Conaghan AbbVie, Eli Lilly and Novartis, AbbVie, AstraZeneca, Eli Lilly, Eupraxia, Galapagos, Genascence, GSK, Grünenthal, Janssen, Levicept, Medipost, Merck, Moebius, Novartis, Sandoz, Stryker, TrialSpark and UCB, Dick de Vries Galapagos, Galapagos, Margaux Faes Galapagos, Galapagos, Mercedes Piovesan Galapagos, Katrien Van Beneden Galapagos, Galapagos, Chris Watson Galapagos, Galapagos, Angelique E. A. M. Weel-Koenders Eli Lilly, Galapagos and Pfizer, Eugen Feist AbbVie, Eli Lilly, Galapagos, Medac, Novartis, Pfizer, Roche and Sobi, AbbVie, Eli Lilly, Galapagos, Novartis, Pfizer, Roche and Sobi, Eli Lilly, Galapagos and Pfizer, Kurt de Vlam Eli Lilly, AbbVie, Amgen, Eli Lilly, Galapagos, Novartis, Pfizer and UCB, AbbVie, Amgen, Eli Lilly, Galapagos, Novartis, Pfizer and UCB, Amgen.