Table 3.
Summary of secondary efficacy end‐points at Weeks 16, 20 and 52 according to initial randomized dose at baseline (FAS)
| Initial tofacitinib 5 mg b.i.d. | Initial tofacitinib 10 mg b.i.d. | |
|---|---|---|
| Mean change from baseline in NAPSI score† (observed cases) (SD) | ||
| Week 16 | −11.3 (14.9) | −10.2 (13.2) |
| Week 20 | −15.1 (15.0) | −14.6 (13.1) |
| Week 52 | −20.6 (15.2) | −16.3 (15.3) |
| Patients achieving NAPSI75 response, n/n (%) (NRI) | ||
| Week 16 | 5/34 (14.7) | 6/31 (19.4) |
| Week 20 | 8/34 (23.5) | 13/31 (41.9) |
| Week 52 | 19/34 (55.9) | 17/31 (54.8) |
| Mean change from baseline in ISI score (observed cases) (SD) | ||
| Week 16 | −4.4 (3.3) | −4.5 (3.1) |
| Week 20 | −5.1 (3.1) | −4.1 (3.3) |
| Week 52 | −4.6 (3.5) | −4.2 (3.1) |
| Proportion of patients with ISI score of ≤1‡, n/n (%) (NRI) | ||
| Week 16 | 31/46 (67.4) | 31/44 (70.5) |
| Week 20 | 35/46 (76.1) | 25/44 (56.8) |
| Week 52 | 30/46 (65.2) | 24/44 (54.5) |
| Mean change from baseline in DLQI score (observed cases) (SD) | ||
| Week 16 | −8.5 (6.4) | −6.7 (5.8) |
| Week 20 | −8.8 (6.7) | −6.8 (5.6) |
| Week 52 | −9.7 (6.4) | −6.1 (5.2) |
| Proportion of patients with DLQI score of ≤1‡, n/n (%) (NRI) | ||
| Week 16 | 29/45 (64.4) | 26/44 (59.1) |
| Week 20 | 30/45 (66.7) | 24/44 (54.5) |
| Week 52 | 27/45 (60.0) | 25/44 (56.8) |
†In patients with nail psoriasis at baseline. ‡In patients with a baseline score of more than 1. DLQI, Dermatology Life Quality Index; FAS, full analysis set (both plaque psoriasis and psoriatic arthritis populations); ISI, Itch Severity Item; NAPSI, Nail Psoriasis Severity Index; NRI, non‐responder imputation; SD, standard deviation.