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Table 2 Least-squares mean change from baseline for patient-reported outcomes in MTX-IR patients; filgotinib dosing regimens compared to placebo and adalimumab

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 + MTX n = 475

FIL 100 mg + MTX n = 480

ADA +MTX n = 325

PBO n = 475

HAQ-DI

 Week 4

− 0.44 (0.04)***

− 0.35 (0.04)***

− 0.40 (0.04)

− 0.25 (0.04)

 Week 12

− 0.69 (0.04)***†

− 0.57(0.04)***

− 0.60 (0.04)

− 0.40 (0.04)

 Week 24

− 0.82 (0.04)***

− 0.74 (0.04)***

− 0.76 (0.04)

− 0.55 (0.04)

 Week 52

− 0.90 (0.04)†

− 0.82 (0.04)

− 0.82 (0.05)

–

SF-36 PCS

 Week 4

6.0 (0.5)***†

5.1 (0.5)***

5.1 (0.6)

3.4 (0.6)

 Week 12

9.7 (0.6)***†

9.1 (0.6)***

8.6 (0.6)

5.9 (0.6)

 Week 24

10.7 (0.6)***

10.6 (0.6)***

10.3 (0.6)

7.6 (0.6)

 Week 52

12.0 (0.6)

11.6 (0.6)

11.9 (0.7)

–

SF-36 MCS

 Week 4

3.3 (0.6)***

3.0 (0.6)**

3.2 (0.7)

1.5 (0.6)

 Week 12

4.8 (0.6)**

5.0 (0.6)**

4.2 (0.7)

3.3 (0.6)

 Week 24

5.4 (0.6)

5.3 (0.6)

4.7 (0.7)

4.4 (0.7)

 Week 52

5.7 (0.7)

6.2 (0.7)

5.5 (0.7)

–

FACIT-Fatigue

 Week 4

6.5 (0.7)***

5.9 (0.7)***

5.7 (0.7)

3.7 (0.7)

 Week 12

9.4 (0.7)***

9.3 (0.7)***

8.8 (0.7)

6.6 (0.7)

 Week 24

10.7 (0.7)***

10.8 (0.7)***

10.0 (0.8)

8.0 (0.7)

 Week 52

11.7 (0.7)

11.8 (0.7)

10.9 (0.8)

–

PtGA

 Week 4

− 23 (1.5)***

− 18 (1.5)***

− 21 (1.6)

− 14 (1.6)

 Week 12

− 34 (1.6)***†

− 30 (1.6)***

− 29 (1.8)

− 21 (1.6)

 Week 24

− 40 (1.6)***

− 37 (1.6)***

− 37 (1.8)

− 29 (1.7)

 Week 52

− 43 (1.7)

− 40 (1.7)

− 41 (1.9)

–

WPAI-RA

 Absenteeism

  Week 4

0.6 (2.1)

− 1.3 (2.1)

− 0.9 (2.4)

− 0.4 (2.2)

  Week 12

− 2.3 (2.0)

− 2.7 (2.0)

− 2.1 (2.3)

− 0.2 (2.2)

  Week 24

− 3.0 (2.0)**

− 3.5 (2.0)**

− 2.3 (2.3)

2.2 (2.2)

  Week 52

− 1.5 (1.8)

− 0.0 (1.9)

0.6 (2.2)

–

 Presenteeism

  Week 4

− 13.1 (2.6)**

− 9.0 (2.5)

− 11.4 (2.9)

− 6.1 (2.7)

  Week 12

− 20.9 (2.6)***

− 20.2 (2.5)**

− 20.3 (2.9)

− 13.0 (2.8)

  Week 24

− 25.2 (2.6)***

− 23.8 (2.6)**

− 21.0 (3.0)

− 16.3 (2.9)

  Week 52

− 28.6 (2.5)

− 27.0 (2.5)

− 25.3 (2.9)

–

 Work productivity loss

  Week 4

− 11.7 (2.8)**

− 7.9 (2.7)

− 10.9 (3.1)

− 5.3 (2.9)

  Week 12

− 19.3 (2.8)**

− 19.2 (2.7)**

− 18.5 (3.2)

− 11.6 (3.0)

  Week 24

− 23.8 (2.9)***

− 22.9 (2.8)***

− 19.2 (3.3)

− 13.4 (3.1)

  Week 52

− 26.8 (2.8)

− 24.4 (2.8)

− 22.7 (3.2)

–

 Activity impairment

  Week 4

− 18.0 (1.7)***

− 16.1 (1.7)***

− 16.0 (1.8)

− 10.6 (1.7)

  Week 12

− 27.3 (1.7)***†

− 25.6 (1.7)***

− 23.7 (1.9)

− 17.9 (1.8)

  Week 24

− 31.5 (1.7)***

− 31.3 (1.8)***

− 29.2 (1.9)

− 22.0 (1.8)

  Week 52

− 35.4 (1.8)

− 35.1 (1.8)

− 33.1 (2.0)

–

  1. Data presented as LS mean (SE). The primary endpoint was assessed at Week 12. Comparison with placebo: ***P < 0.001, **P < 0.01. Comparison with adalimumab: †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. In FINCH 1, patients on PBO were rerandomized to FIL 200 or 100 mg at week 24.
  2. ADA, adalimumab; FACIT, Functional Assessment of Chronic Illness Therapy; FIL, filgotinib; LS, least-squares; HAQ-DI, Health Assessment Questionnaire-Disability Index; MCS, Mental Component Score; MTX, methotrexate; 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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Arthritis Research & Therapy

ISSN: 1478-6362

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