Patient demographics and baseline disease characteristics in the P2/P3 cohort
| bDMARD-naive | bDMARD-IR | |||||
|---|---|---|---|---|---|---|
| Placebo N=651 | Tofacitinib 5 mg twice daily N=1071 | Tofacitinib 10 mg twice daily N=1090 | Placebo N=193 | Tofacitinib 5 mg twice daily N=259 | Tofacitinib 10 mg twice daily N=253 | |
| Caucasian, % | 54.2 | 54.4 | 56.1 | 81.9 | 78.8 | 75.5 |
| Female, % | 82.8 | 85.0 | 85.0 | 81.9 | 84.2 | 83.0 |
| Age in years, mean (SD) | 52.0 (12.5) | 52.6 (11.9) | 52.3 (11.6) | 54.0 (11.6) | 54.7 (11.1) | 54.9 (10.9) |
| Mean (SD) weight, kg | 67.0 (17.7) | 68.3 (17.9) | 69.0 (18.0) | 78.9 (23.0) | 77.3 (22.3) | 77.4 (22.1) |
| Geographic region, % | ||||||
| USA | 12.0 | 11.4 | 12.9 | 44.0 | 44.8 | 47.8 |
| Europe and Canada | 34.4 | 35.5 | 35.3 | 38.3 | 32.0 | 30.0 |
| Latin America | 18.1 | 18.4 | 17.8 | 6.2 | 6.2 | 5.1 |
| Rest of world | 35.5 | 34.7 | 33.9 | 11.4 | 17.0 | 17.0 |
| Mean (SD) disease duration, years | 8.2 (8.2) | 7.7 (7.4) | 8.1 (7.9) | 11.2 (8.6) | 12.1 (9.1) | 12.6 (8.6) |
| Mean (SD) BMI | 25.6 (5.7) | 26.2 (6.1) | 26.5 (6.1) | 29.3 (7.6) | 29.0 (7.7) | 28.8 (7.3) |
| % RF+ | 70.2 | 72.4 | 71.7 | 62.2 | 65.2 | 66.7 |
| % anti-CCP+ (≥60 units) | 69.0 | 67.2 | 65.6 | 62.7 | 63.2 | 65.3 |
| Mean (SD) DAS28-4(ESR)* | 6.3 (1.0) | 6.4 (1.0) | 6.4 (1.0) | 6.4 (1.1) | 6.5 (1.0) | 6.5 (0.9) |
| Mean (SD) HAQ-DI* | 1.3 (0.7) | 1.4 (0.7) | 1.4 (0.7) | 1.6 (0.6) | 1.6 (0.6) | 1.5 (0.6) |
| Mean (SD) SDAI* | 38.0 (13.2) | 38.9 (12.9) | 38.6 (12.8) | 39.9 (13.7) | 40.7 (13.4) | 39.8 (13.2) |
| Mean (SD) CDAI* | 36.2 (12.8) | 37.0 (12.3)* | 36.8 (12.5) | 38.3 (13.3) | 38.6 (12.5) | 37.8 (12.3) |
| Mean (SD) tender joint count* | 23.8 (13.9) | 25.1 (14.7) | 25.1 (14.9) | 27.8 (16.9) | 28.8 (16.7) | 27.6 (15.8) |
| Mean (SD) swollen joint count* | 15.2 (9.0) | 15.1 (9.2) | 15.0 (8.6) | 16.8 (10.6) | 16.1 (9.4) | 16.5 (10.2) |
| Mean (SD) pain VAS* | 56.1 (23.2) | 58.6 (23.4) | 59.1 (23.1) | 60.1 (23.5) | 64.3 (21.9) | 61.4 (21.4) |
| Mean (SD) PtGA VAS* | 56.3 (22.8) | 59.5 (22.9) | 59.0 (23.2) | 61.2 (22.7) | 64.4 (22.0) | 61.5 (21.7) |
| Mean (SD) PGA VAS* | 59.1 (17.0) | 60.3 (16.8) | 59.3 (16.8) | 63.4 (16.6) | 65.1 (17.4) | 62.5 (18.6) |
| Mean (SD) CRP, mg/L* | 13.5 (18.0) | 16.2 (22.1) | 15.5 (19.9) | 15.7 (18.8) | 19.6 (25.7) | 18.8 (30.6) |
| Mean (SD) ESR, mm/h* | 49.0 (25.0) | 50.7 (26.6) | 49.9 (26.1) | 45.7 (24.0) | 47.1 (26.0) | 49.1 (27.6) |
| Previously taken methotrexate, % | 89.6 | 90.4 | 90.9 | 96.4 | 95.0 | 90.9 |
| Previously taken DMARDs other than methotrexate, % | 61.8 | 61.1 | 61.7 | 33.2 | 49.8 | 47.8 |
| Previously taken TNFi, % | 0 | 0 | 0 | 95.9 | 94.2 | 97.2 |
| Previously taken any other DMARDs, n (%) | 0 | 0 | 0 | 38 (19.7) | 62 (23.9) | 49 (19.4) |
| Abatacept | 23 | 33 | 33 | |||
| Anakinra | 3 | 6 | 3 | |||
| Rituximab | 7 | 16 | 11 | |||
| Tocilizumab | 7 | 14 | 12 | |||
| Other | 2 | 6 | 2 | |||
| TNFi (no other bDMARD taken)†, n (%) | 0 | 0 | 0 | 155 (80.3) | 197 (76.1) | 204 (80.6) |
| One TNFi‡ | 97 (62.6) | 120 (60.9) | 140 (68.6) | |||
| Multiple TNFi‡ | 58 (37.4) | 77 (39.1) | 64 (31.4) | |||
| Other bDMARDs (no TNFi taken)†, n (%) | 0 | 0 | 0 | 8 (4.1) | 15 (5.8) | 7 (2.8) |
| TNFi and other bDMARDs†, n (%) | 0 | 0 | 0 | 30 (15.5) | 47 (18.1) | 42 (16.6) |
| One TNFi and other bDMARD§ | 17 (56.7) | 25 (53.2) | 15 (35.7) | |||
| Multiple TNFi and other bDMARDs§ | 13 (43.3) | 22 (46.8) | 27 (64.3) | |||
*The denominators were slightly less than the numbers of randomised patients (Ns), based on data collection and availability.
†% based on denominator of the total number of patients (per treatment) in the bDMARD-IR population, and these groups are mutually exclusive. ‡% based on denominator of the total number of patients (per treatment) who had previously taken TNFi in the bDMARD-IR population. §% based on denominator of the total number of patients (per treatment) who had previously taken TNFi and other bDMARDs in the bDMARD-IR population.
bDMARD, biological disease-modifying antirheumatic drug; BMI, body mass index; CCP, cyclic citrullinated peptide; CDAI, Clinical Disease Activity Index; CRP, C reactive protein; DAS, disease activity score; DMARD, disease-modifying antirheumatic drug; ESR, erythrocyte sedimentation rate; HAQ-DI, Health Assessment Questionnaire-Disability Index; IR, inadequate responders; N, number of patients included in analysis; P2/P3, phase II/phase III; PGA, Physician Global Assessment of Arthritis; PtGA, Patient Global Assessment of Arthritis; RF, rheumatoid factor; SDAI, Simplified Disease Activity Index; TNFi, tumour necrosis factor inhibitor; VAS, visual analogue scale.