Efficacy endpoints at month 3 and month 6 (full analysis set)†‡
| Endpoint | Month 3 | Month 6 | ||||
| Tofacitinib 5 mg BID (N=136) | Placebo (N=68) | Difference (SE) (95% CI) | Tofacitinib 5 mg BID (N=136) | Placebo→ tofacitinib 5 mg BID (N=68) | Difference (SE) (95% CI) | |
| ACR50, n (%) (SE) | 52 (38.2) (4.2)§ | 4 (5.9) (2.9)§ | 32.4 (5.1)§ (22.5 to 42.3)*** | 75 (55.2) (4.3) | 25 (36.8) (5.9) | 18.4 (7.2) (4.2 to 32.6)* |
| ACR50 excl. COVID-19, n (%) (SE) | 52 (40.6) (4.3) (N1=128) | 4 (6.3) (3.0) (N1=64) | 34.4 (5.3) (24.0 to 44.8)*** | N/A | N/A | N/A |
| ACR20, n (%) (SE) | 88 (64.7) (4.1) | 19 (27.9) (5.4) | 36.8 (6.8) (23.4 to 50.1)*** | 99 (72.8) (3.8) | 40 (58.8) (6.0) | 14.0 (7.1) (0.1 to 27.9)* |
| ACR70, n (%) (SE) | 20 (14.7) (3.0) | 1 (1.5) (1.5) | 13.2 (3.4) (6.6 to 19.8)*** | 50 (36.8) (4.1) | 16 (23.5) (5.1) | 13.2 (6.6) (0.3 to 26.2)* |
| HAQ-DI response, n (%) (SE)¶†† | 54 (65.1) (5.2) (N1=83) | 16 (41.0) (7.9) (N1=39) | 24.0 (9.5) (5.5 to 42.6)* | 61 (73.5) (4.8) (N1=83) | 26 (66.7) (7.6) (N1=39) | 6.8 (9.0) (−10.8 to 24.4) |
| ∆HAQ-DI (SE) | −0.3 (0.0) (N1=127) | −0.1 (0.0) (N1=62) | −0.2 (0.1) (−0.3 to −0.1)*** | −0.4 (0.0) (N1=126) | −0.3 (0.0) (N1=61) | −0.1 (0.0) (−0.2 to 0.0) |
| ∆TJC (SE) | −8.9 (0.6) (N1=123) | −1.9 (0.9) (N1=60) | −7.0 (1.1) (−9.2 to −4.8)*** | −11.9 (0.6) (N1=115) | −9.5 (0.9) (N1=57) | −2.4 (1.1) (−4.6 to −0.2)* |
| ∆SJC (SE) | −6.4 (0.5) (N1=123) | −0.6 (0.7) (N1=60) | −5.9 (0.9) (−7.5 to −4.2)*** | −8.1 (0.4) (N1=115) | −5.5 (0.5) (N1=57) | −2.6 (0.7) (−3.9 to −1.3)** |
| ∆CGA (SE) | −29.5 (1.4) (N1=123) | −11.0 (2.1) (N1=60) | −18.4 (2.5) (−23.4 to −13.5)*** | −38.8 (1.3) (N1=114) | −31.1 (1.9) (N1=57) | −7.7 (2.3) (−12.1 to −3.2)*** |
| ∆Pain (VAS) (SE) | −23.1 (1.7) (N1=127) | −1.2 (2.5) (N1=62) | −21.9 (3.0) (−27.8 to −15.9)*** | −29.4 (1.7) (N1=124) | −26.3 (2.4) (N1=59) | −3.1 (3.0) (9.0 to 2.8) |
| ∆PtGA (SE) | −26.0 (1.8) (N1=127) | −7.3 (2.6) (N1=62) | −18.8 (3.2) (−25.1 to −12.5)*** | −33.5 (1.7) (N1=124) | −28.4 (2.4) (N1=59) | −5.1 (2.9) (−10.9 to 0.6) |
| PsARC response, n (%) | 94 (69.1) | 20 (29.4) | 39.7 (6.8) (26.4 to 53.0)*** | 108 (79.4) | 43 (63.2) | 16.2 (6.8) (2.9 to 29.5)* |
| PGA-PsO response, n (%) (SE)‡‡ | 10 (9.4) (2.8) (N1=106) | 1 (2.0) (1.9) (N1=51) | 7.5 (3.4) (0.7 to 14.2)* | 11 (10.4) (3.0) (N1=106) | 11 (21.6) (5.8) (N1=51) | −11.2 (6.5) (−23.9 to 1.5) |
| ∆PGA-PsO (SE) | −1.12 (0.1) (N1=119) | −0.5 (0.1) (N1=58) | −0.6 (0.1) (−0.9 to −0.3)*** | −1.3 (0.1) (N1=112) | −1.3 (0.1) (N1=54) | 0.0 (0.2) (−0.3 to 0.3) |
| PASI75, n (%) (SE)§§ | 27 (36.0) (5.5) (N1=75) | 3 (11.1) (6.1) (N1=27) | 24.9 (8.2) (8.8 to 41.0)** | 31 (41.3) (5.7) (N1=75) | 16 (59.3) (9.5) (N1=27) | −17.9 (11.0) (−39.6 to 3.7) |
| Resolution of enthesitis, n (%) (SE)¶¶ | 35 (49.3) (5.9) (N1=71) | 7 (25.0) (8.2) (N1=28) | 24.3 (10.1) (4.5 to 44.1)* | 46 (64.8) (5.7) (N1=71) | 17 (60.7) (9.2) (N1=28) | 4.1 (10.8) (−17.2 to 25.3) |
| ∆LEI (SE) | −1.4 (0.2) (N1=63) | −1.0 (0.3) (N1=24) | −0.4 (0.3) (−1.0 to 0.2) | −1.9 (0.1) (N1=59) | −1.6 (0.2) (N1=23) | −0.3 (0.2) (−0.7 to 0.2) |
| Resolution of dactylitis, n (%) (SE)††† | 42 (45.2) (5.2) (N1=93) | 8 (19.5) (6.2) (N1=41) | 25.7 (8.1) (9.9 to 41.4)** | 60 (64.5) (5.0) (N1=93) | 17 (41.5) (7.7) (N1=41) | 23.1 (9.2) (5.1 to 41.0)* |
| ∆DSS (SE) | −6.6 (0.5) (N1=86) | −2.5 (0.8) (N1=37) | −4.1 (1.0) (−6.0 to −2.1)*** | −7.8 (0.2) (N1=79) | −6.8 (0.3) (N1=34) | −1.0 (0.3) (−1.7 to −0.3)** |
| ∆NAPSI (SE) | −1.0 (0.2) (N1=86) | −0.8 (0.2) (N1=48) | −0.2 (0.3) (−0.8 to 0.4) | −2.4 (0.2) (N1=82) | −2.1 (0.3) (N1=47) | −0.3 (0.3) (−1.0 to 0.3) |
| ∆CRP mg/L (SE) | −9.8 (0.7) (N1=123) | −2.0 (1.0) (N1=60) | −7.8 (1.2) (−10.2 to −5.4)*** | −10.2 (0.4) (N1=115) | −9.0 (0.6) (N1=56) | −1.3 (0.8) (−2.8 to 0.3) |
| ∆DAS28-3(CRP) (SE) | −1.3 (0.1) (N1=123) | −0.3 (0.1) (N1=60) | −1.0 (0.1) (−1.3 to −0.8)*** | −1.9 (0.1) (N1=115) | −1.6 (0.1) (N1=56) | −0.2 (0.1) (−0.5 to 0.1) |
| ∆SF-36v2 PCS (SE) | 6.0 (0.6) (N1=125) | 1.9 (0.8) (N1=62) | 4.2 (1.0) (2.2 to 6.1)*** | 7.9 (0.6) (N1=126) | 7.6 (0.8) (N1=61) | 0.4 (1.0) (−1.6 to 2.4) |
| ∆SF-36v2 MCS (SE) | 3.4 (0.7) (N1=125) | 0.1 (1.0) (N1=62) | 3.3 (1.2) (0.8 to 5.7)** | 4.0 (0.8) (N1=126) | 2.2 (1.2) (N1=61) | 1.8 (1.4) (−1.0 to 4.6) |
| MDA, n (%) (SE)‡‡‡ | 44 (32.4) (4.0) | 4 (5.9) (2.9) | 26.5 (4.9) (16.8 to 36.1)*** | 67 (49.3) (4.3) | 25 (36.8) (5.9) | 12.5 (7.3) (-1.7 to 26.7) |
*p<0.05; **p<0.01; ***p<0.001 versus placebo (to month 3) or placebo→tofacitinib 5 mg BID (for remainder of study).
†All randomised patients who received ≥1 dose of study medication.
‡For change from baseline endpoints, missing values were not imputed; for binary endpoints, missing values were considered as non-response.
§Primary endpoint.
¶Defined as a decrease in HAQ-DI from baseline ≥0.30 in patients with baseline HAQ-DI ≥0.30.
††Identical results were observed for HAQ-DI response rate based on a decrease from baseline ≥0.35 in patients with baseline HAQ-DI ≥0.35.
‡‡In patients with PGA-PsO ≥2 at baseline.
§§In patients with psoriatic BSA ≥3% and PASI>0 at baseline.
¶¶In patients with baseline LEI >0, with resolution of enthesitis defined as LEI=0.
†††In patients with baseline DSS >0, with resolution of dactylitis defined as DSS=0.
‡‡‡Defined as meeting ≥5 out of 7 items: ≤1 tender joint, ≤1 swollen joint, a PASI score of ≤1 or a BSA covered by psoriasis of ≤3%, pain VAS ≤15 mm, PtGA VAS ≤20 mm, HAQ-DI ≤0.5, and ≤1 tender enthesitis site (based on LEI).
∆, change from baseline; ACR, American College of Rheumatology; BID, twice daily; BSA, body surface area; CGA, Clinician's Global Assessment of arthritis; CI, confidence interval; CRP, C-reactive protein; DAS28-3(CRP), Disease Activity Score in 28 joints with CRP; DSS, Dactylitis Severity Score; HAQ-DI, Health Assessment Questionnaire-Disability Index; LEI, Leeds Enthesitis Index; MCS, Mental Component Summary; MDA, minimal disease activity; N1, number of evaluable patients at each time point; n, number of patients with the specified characteristic; N, number of patients; NAPSI, Nail Psoriasis Severity Index; PASI, Psoriasis Area and Severity Index; PCS, Physical Component Summary; PGA-PsO, Physician’s Global Assessment of Psoriasis; PsARC, Psoriatic Arthritis Response Criteria; PtGA, Patient’s Global Assessment of arthritis; SE, standard error; SF-36v2, Short Form-36 Health Survey, version 2 acute; SJC, swollen joint count; TJC, tender joint count; VAS, Visual Analogue Scale.