The impact of filgotinib on patient-reported outcomes and health-related quality of life for patients with active rheumatoid arthritis: a post hoc analysis of Phase 3 studies

Bingham, Clifton O.; Walker, David; Nash, Peter; Lee, Susan J.; Ye, Lei; Hu, Hao; Khalid, Javaria Mona; Combe, Bernard

doi:10.1186/s13075-021-02677-7

Table 3 Least-squares mean change from baseline for patient-reported outcomes in bDMARD-IR patients; filgotinib dosing regimens compared to placebo

From: The impact of filgotinib on patient-reported outcomes and health-related quality of life for patients with active rheumatoid arthritis: a post hoc analysis of Phase 3 studies

PRO measures	FIL 200 mg + csDMARD n = 147	FIL 100 mg + csDMARD n = 153	PBO + csDMARD n = 148
HAQ-DI
Week 4	− 0.35 (0.05)^***	− 0.28 (0.05)^**	− 0.13 (0.05)
Week 12	− 0.50 (0.06)^***	− 0.46 (0.05)^***	− 0.19 (0.06)
Week 24	− 0.63 (0.06) ^***	− 0.49 (0.06)^**	− 0.27 (0.06)
SF-36 PCS
Week 4	5.9 (0.7) ^***	5.4 (0.7)^**	3.4 (0.7)
Week 12	8.4 (0.8)^***	7.6 (0.8)^***	4.2 (0.8)
Week 24	9.6 (0.8)^***	8.9 (0.8)^**	5.8 (0.9)
SF-36 MCS
Week 4	2.5 (0.9)^*	2.0 (0.9)	0.3 (0.9)
Week 12	4.5 (0.9) ^*	3.5 (0.9)	2.5 (0.9)
Week 24	4.9 (1.0)	3.1 (1.0)	3.0 (1.1)
FACIT-Fatigue
Week 4	6.9 (1.0) ^***	6.6 (1.0)^**	3.3 (1.0)
Week 12	10.2 (1.0)^***	8.4 (1.0)^**	5.2 (1.1)
Week 24	11.5 (1.1)^***	9.0 (1.1)	6.9 (1.2)
PtGA
Week 4	− 21 (2.3) ^***	− 20 (2.3)^***	− 9 (2.4)
Week 12	− 31 (2.5)^***	− 26 (2.5)^***	− 13 (2.6)
Week 24	− 36 (2.6)^***	− 30 (2.7)^***	− 18 (2.8)
WPAI-RA
Absenteeism
Week 4	− 5.9 (3.5)	− 1.3 (2.9)	2.4 (3.0)
Week 12	− 6.9 (3.6)^*	− 3.0 (3.0)	3.1 (3.2)
Week 24	− 5.7 (4.4)	− 0.5 (3.9)	4.1 (4.5)
Presenteeism
Week 4	− 22.0 (3.9) ^***	− 12.5 (3.3)	− 3.1 (3.5)
Week 12	− 23.5 (4.1)^**	− 18.0 (3.5)^*	− 6.8 (3.6)
Week 24	− 20.9 (4.0)	− 24.6 (3.7)	− 15.1 (4.0)
Work productivity loss
Week 4	− 22.9 (4.1) ^***	− 11.3 (3.5)	− 2.7 (3.7)
Week 12	− 25.8 (4.4)^***	− 17.7 (3.7)^*	− 5.7 (3.9)
Week 24	− 21.7 (4.6)	− 22.8 (4.3)	− 12.8 (4.7)
Activity impairment
Week 4	− 15.9 (1.9) ^***	− 14.2 (1.9)^***	− 4.6 (1.9)
Week 12	− 24.4 (2.1) ^***	− 18.8 (2.1)^**	− 10.5 (2.1)
Week 24	− 30.1 (2.2) ^***	− 24.4 (2.3)^**	− 15.4 (2.4)

Data presented as LS mean (SE). The primary endpoint was assessed at Week 12. Comparison with placebo: ^***P < 0.001, ^**P < 0.01, ^*P < 0.05. All P values are exploratory (not adjusted for multiplicity) and assessed using the MMRM, including treatment group, visit, treatment group by visit interaction, stratification factors, baseline value as fixed effects, and patients as random effect. The FINCH 2 study ended at week 24.
csDMARD, conventional synthetic disease-modifying antirheumatic drug; FACIT, Functional Assessment of Chronic Illness Therapy; FIL, filgotinib; LS, least-squares; HAQ-DI, Health Assessment Questionnaire-Disability Index; MCS , Mental Component Score; PBO, placebo; PCS, Physical Component Score; PRO, patient-reported outcomes; PtGA , Patient Global Assessment of Disease Activity; SE, standard error; SF-36 , Medical Outcomes Study 36-Item Short Form; WPAI-RA, Work Productivity and Activity Impairment Questionnaire-Rheumatoid Arthritis

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