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Table 1 Least-squares mean change from baseline for patient-reported outcomes in MTX-naïve patients; filgotinib dosing regimens compared to MTX

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 = 416

FIL 100 mg + MTX n = 207

FIL 200 mg n = 210

MTX n = 416

HAQ-DI

 Week 4

− 0.64 (0.03)***

− 0.50 (0.04)***

− 0.56 (0.04)***

− 0.35 (0.03)

 Week 12

− 0.91 (0.03)***

− 0.82 (0.04)***

− 0.80 (0.04)***

− 0.64 (0.03)

 Week 24

− 1.00 (0.03)***

− 0.94 (0.04)**

− 0.91 (0.04)*

− 0.81 (0.03)

 Week 52

− 1.03 (0.04)***

− 0.96 (0.05)

− 0.98 (0.05)*

− 0.87 (0.04)

SF-36 PCS

 Week 4

7.3 (0.4)***

5.8 (0.5)**

6.4 (0.5)***

4.1 (0.4)

 Week 12

11.6 (0.4)***

9.6 (0.6)**

9.4 (0.6)*

7.9 (0.4)

 Week 24

12.8 (0.5)***

11.5 (0.6)*

10.8 (0.6)

9.9 (0.5)

 Week 52

13.6 (0.5)***

12.0 (0.7)

12.2 (0.7)

10.8 (0.5)

SF-36 MCS

 Week 4

4.6 (0.5)***

3.4 (0.6)*

4.3 (0.6)***

1.9 (0.5)

 Week 12

5.7 (0.5)*

5.7 (0.7)

5.4 (0.7)

4.3 (0.5)

 Week 24

5.9 (0.5)

6.3 (0.7)

5.5 (0.7)

5.7 (0.5)

 Week 52

6.5 (0.5)

6.2 (0.7)

5.8 (0.7)

5.8 (0.6)

FACIT-Fatigue

 Week 4

7.6 (0.5)***

6.9 (0.6)***

7.1 (0.6)***

4.4 (0.5)

 Week 12

10.3 (0.5)***

9.3 (0.7)

9.8 (0.7)*

8.1 (0.5)

 Week 24

11.3 (0.6)

11.3 (0.7)

10.3 (0.7)

10.0 (0.6)

 Week 52

12.1 (0.6)*

11.4 (0.8)

11.6 (0.8)

10.4 (0.6)

PtGA

    

 Week 4

− 28 (1.2)***

− 21 (1.6)**

− 23 (1.6)***

− 15 (1.2)

 Week 12

− 38 (1.3)***

− 31 (1.7)**

− 32 (1.7)**

− 26 (1.3)

 Week 24

− 44 (1.3)***

− 38 (1.7)

− 38 (1.7)

− 34 (1.3)

 Week 52

− 46 (1.4)***

− 40 (1.8)

− 43 (1.8)**

− 37 (1.4)

WPAI-RA

 Absenteeism

  Week 4

− 2.9 (2.0)

− 0.3 (2.8)

− 4.8 (2.7)

− 0.2 (2.1)

  Week 12

− 6.2 (1.9)

− 8.3 (2.6)

− 2.9 (2.4)

− 3.8 (1.8)

  Week 24

− 6.7 (1.7)

− 10.2 (2.3)

− 3.6 (2.1)*

− 9.0 (1.7)

  Week 52

− 7.0 (1.8)

− 7.9 (2.5)

− 4.2 (2.4)

− 7.6 (1.9)

 Presenteeism

  Week 4

− 19.4 (2.0)***

− 22.3 (2.8)***

− 17.3 (2.6)**

− 7.2 (2.1)

  Week 12

− 27.2 (2.0) **

− 28.2 (2.8)*

− 25.4 (2.6)

− 19.9 (2.0)

  Week 24

− 29.8 (1.9)

− 32.2 (2.7)

− 27.5 (2.5)

− 26.8 (2.0)

  Week 52

− 33.6 (1.9)

− 30.7 (2.7)

− 32.2 (2.5)

− 30.0 (2.1)

 Work productivity loss

  Week 4

− 19.0 (2.1)***

− 21.8 (3.0)***

− 17.1 (2.8)**

− 6.6 (2.2)

  Week 12

− 27.6 (2.2)**

− 28.1 (3.1)*

− 23.4 (2.9)

− 19.5 (2.2)

  Week 24

− 30.3 (2.1)

− 30.5 (3.0)

− 24.6 (2.8)

− 26.4 (2.2)

  Week 52

− 33.4 (2.2)

− 31.2 (3.1)

− 29.8 (2.9)

− 30.3 (2.4)

 Activity impairment

  Week 4

− 23.2 (1.3)***

− 17.8 (1.7)*

− 19.7 (1.7)**

− 13.5 (1.3)

  Week 12

− 32.5 (1.4)***

− 28.1 (1.8)*

− 30.5 (1.8)***

− 23.6 (1.4)

  Week 24

− 36.4 (1.4)*

− 34.6 (1.8)

− 32.7 (1.8)

− 32.3 (1.4)

  Week 52

− 39.9 (1.4)**

− 36.4 (1.9)

− 38.4 (1.9)

− 34.5 (1.5)

  1. Data presented as LS mean (SE). The primary endpoint was assessed at Week 24. Comparison with methotrexate: ***P < 0.001, **P < 0.01, *P < 0.05. All P values are exploratory (not adjusted for multiplicity) and were assessed using the MMRM, including treatment group, visit, treatment group by visit interaction, stratification factors, and baseline value as fixed effects, and patients as random effect.
  2. FACIT, Functional Assessment of Chronic Illness Therapy; FIL, filgotinib; HAQ-DI, Health Assessment Questionnaire-Disability Index; LS, least-squares; MCS, Mental Component Score; MTX, methotrexate; 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