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Table 2 Change from baseline in patient reported outcome scores at week 12 and week 24

From: Effect of filgotinib, a selective JAK 1 inhibitor, with and without methotrexate in patients with rheumatoid arthritis: patient-reported outcomes

Time-point Methotrexate add-on study dosing group Monotherapy study dosing group
  Once daily (q.d.) Twice daily (b.i.d.) Once daily (q.d.)
Placebo 50 100 200 25 50 100 Placebo 50 100 200
Health Assessment Questionnaire-Disability Index (HAQ-DI), points
 Week 12 −0.38 −0.58 −0.65* −0.75*** −0.59 −0.58 −0.84*** −0.23 −0.66*** −0.68*** −0.74***
 Week 24 −0.37 −0.63 −0.78*** −0.82*** −0.62** −0.66** −0.90*** NAa −0.69 −0.79 −0.85
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale, points
 Week 12 5.6 7.6 9.5* 11.4*** 6.9 8.4 11.3*** 3.9 9.5*** 10.2*** 11.2***
 Week 24 6.0 7.9 11.1*** 11.6** 7.7 9.0 12.8*** NAa 10.0 11.3 13.7
Patient global assessment of disease activity (Patient Global), mm
 Week 12 −16.7 −25.2 −29.1* −34.2*** −25.2* −27.0* −35.6*** −11.5 −27.5*** −30.0*** −28.2***
 Week 24 −17.9 −29.4* −34.4* −34.9* −27.3* −28.1* −39.1*** NAa −29.1 −32.2 −35.1
Pain, mm
 Week 12 −16.9 −24.8 −27.4* −31.4** −24.2 − 28.3* −37.9*** −13.3 −29.2*** −31.5*** −31.3***
 Week 24 −17.0 −27.1* −32.7*** −34.6*** −26.9* −27.7* −37.9*** NAa −29.1 −35.1 −37.7
Short Form-36: Physical component score (PCS), points
 Week 12 3.2 6.7** 8.4*** 8.9*** 7.5** 7.1** 10.5*** 3.0 7.1** 7.8*** 8.6***
 Week 24 2.8 7.3*** 9.9*** 9.7*** 7.8*** 7.9*** 11.6*** NAa 6.9 10.0 9.7
Short Form-36: Mental component score (MCS), points
 Week 12 4.3 4.4 5.1 8.1 3.5 3.1 6.2 2.7 4.9* 6.9** 6.8**
 Week 24 4.7 4.3 6.7 7.2 3.8 3.5 7.1 NAa 5.1 7.7 8.5
  1. b.i.d. twice daily; HAQ-DI Health Assessment Questionnaire-Disability Index, FACIT Functional Assessment of Chronic Illness Therapy, MCS mental component summary score, PCS physical component summary score, Patient Global Patient Global Assessment of Disease Activity, q.d. once daily
  2. aAt week 12, patients receiving placebo in the add-on study and patients receiving placebo and filgotinib 50 mg q.d. in the monotherapy study who had not achieved a 20% improvement in swollen joint count and tender joint count were reassigned to receive filgotinib 100 mg q.d. (both studies) or 50 mg b.i.d. (methotrexate add-on study only). Patients who switched treatments at week 12 were handled as discontinuations and data were imputed from week 12 onwards using last observation carried forward
  3. P values given for pair-wise comparison with placebo: *p < 0.05; **p < 0.01; ***p < 0.001