Table 2.

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.