Session Information
Session Type: Poster Session (Sunday)
Session Time: 9:00AM-11:00AM
Background/Purpose: There is an unmet medical need to treat RA in patients who have failed prior biologic DMARD treatments (biologic DMARD inadequate response; bDMARD-IR), some of which target the IL-6 pathway. Patients who are bDMARD-IR are considered more treatment resistant and have more variable responses to treatment than treatment- or bDMARD-naïve patients. Questions remain as to whether the clinical efficacy of the oral, selective Janus kinase (JAK)-1 inhibitor filgotinib differs among patients with prior exposure to IL-6 inhibitors. We explored the efficacy of filgotinib in bDMARD-IR patients with active RA based on number and mechanism of action (MOA) of prior biologics.
Methods: The global, phase 3 FINCH-2 (NCT02873936) study enrolled 449 bDMARD-IR patients with active RA, who were randomized in a 1:1:1 manner to receive once-daily filgotinib 200 mg, filgotinib 100 mg, or placebo for 24 weeks.1 This subgroup analysis evaluated filgotinib efficacy respective to the number and MOA of prior bDMARD use. Clinical efficacy was assessed using ACR20, DAS28(CRP) for low disease activity and remission, and patient-reported outcomes at weeks 12 and 24. Quality-of-life outcomes were assessed by change in HAQ disability index (HAQ-DI), change in SF-36-Physical Component score, and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at weeks 12 and 24.
Results: Of the 448 patients randomized and treated at baseline, 80.4% were female with a mean age of 56 years and a mean RA duration of 12.4 years. Prior bDMARD exposure, including the total number and MOA, was well balanced amongst the 3 treatment arms. Clinical efficacy outcomes—as measured by ACR20, DAS28(CRP) ≤3.2, and DAS28(CRP) < 2.6—are provided in Table 1. Quality-of-life outcomes—as measured by change in HAQ-DI, change in SF-36-Physical Component score, and FACIT-F at week 12—are provided in Table 2.
Conclusion: Compared with placebo, filgotinib demonstrated improved clinical outcomes in bDMARD refractory patients. The efficacy observed with filgotinib was maintained with no significant effects based on the number and MOA of prior bDMARD use, including in patients with prior exposure to IL-6 inhibitors.
References:
1. Genovese MC, et al. Safety and Efficacy of Filgotinib in a Phase 3 Trial of Patients with Active Rheumatoid Arthritis and Inadequate Response or Intolerance to Biologic Dmards [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 10).
Table 1_DMARDs
Data presented as n -%- unless otherwise specified.
bDMARD, biologic DMARD; CI, confidence interval; FIL, filgotinib; MOA, mechanism of action; PBO, placebo; QD, once daily.
Table 2_DMARDs
Data presented as mean -SD- unless otherwise specified.
bDMARD, biologic DMARD; CI, confidence interval; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue; FIL, filgotinib; LSM, least squares mean; MOA, mechanism of action; PBO, placebo; PCS, physical component summary; QD, once daily; SD, standard deviation.
To cite this abstract in AMA style:
Genovese M, de Vlam K, Gottenberg J, Bartok B, Tiamiyu I, Guo Y, Tasset C, Sundy J, Walker D, Takeuchi T, Kalunian K. A Subgroup Analysis of Clinical Efficacy Response and Quality of Life Outcomes from Phase 3 Study of Filgotinib in Patients with Inadequate Response to Biologic DMARDs [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/a-subgroup-analysis-of-clinical-efficacy-response-and-quality-of-life-outcomes-from-phase-3-study-of-filgotinib-in-patients-with-inadequate-response-to-biologic-dmards/. Accessed .« Back to ACR/ARP Annual Meeting 2019
ACR Meeting Abstracts - https://acrabstracts.org/abstract/a-subgroup-analysis-of-clinical-efficacy-response-and-quality-of-life-outcomes-from-phase-3-study-of-filgotinib-in-patients-with-inadequate-response-to-biologic-dmards/