Analysis population | Tofacitinib 5 mg BID | Tofacitinib 10 mg BID | Placebo |
RA csDMARD-IR, % (SE) | 53.43 (1.79)*** | 57.03 (1.78)*** | 27.69 (2.27) |
RA TNFi-IR, % (SE) | 57.02 (4.64)*** | 49.58 (4.58)** | 30.43 (4.29) |
PsA csDMARD-IR, % (SE) | 50.49 (4.93)*** | 54.37 (4.91)*** | 27.45 (4.42) |
PsA TNFi-IR, % (SE) | 52.42 (4.48)*** | 51.26 (4.58)*** | 26.50 (4.08) |
Significance is given as unadjusted p values, compared with placebo: **p<0.01, ***p<0.001. Missing values were not imputed. At month 3, the number of patients evaluable (FAS, N) was: RA csDMARD-IR, n=1938 (tofacitinib 5 mg BID, n=773; tofacitinib 10 mg BID, n=775; placebo, n=390); RA TNFi-IR, n=348 (tofacitinib 5 mg BID, n=114; tofacitinib 10 mg BID, n=119; placebo, n=115); PsA csDMARD-IR, n=308 (tofacitinib 5 mg BID, n=103; tofacitinib 10 mg BID, n=103; placebo, n=102); PsA TNFi-IR, n=360 (tofacitinib 5 mg BID, n=124; tofacitinib 10 mg BID, n=119; placebo, n=117).
*PAAP measured using a VAS (0–100 mm; higher score=worse arthritis pain).
BID, twice daily; csDMARD, conventional synthetic disease-modifying antirheumatic drug; FAS, full analysis set; IR, inadequate response; PAAP, Patient's Assessment of Arthritis Pain; PsA, psoriatic arthritis; RA, rheumatoid arthritis; SE, standard error; TNFi, tumour necrosis factor inhibitor; VAS, visual analogue scale.