Table 2.
Median time to continued improvement events (Kaplan–Meier analysis)
| Improvement threshold | Median time, weeks (interquartile range) | p value | |
|---|---|---|---|
| Tofacitinib 5 mg BID (N = 133) |
Placebo-to-tofacitiniba (N = 136) |
||
| ≥ 30% improvement | |||
| Total back painb | 8 (2–32) | 24 (16–NE) | < 0.0001 |
| Nocturnal painb | 4 (2–40) | 24 (16–NE) | < 0.0001 |
| ≥ 50% improvement | |||
| Total back painb | 24 (4–NE) | NE | 0.0003 |
| Nocturnal painb | 12 (4–NE) | 40 (24–NE) | < 0.0001 |
| BASDAI questions | |||
| Fatigue (Q1) | 40 (8–NE) | NE | 0.0212 |
| Spinal pain (Q2) | 24 (4–NE) | NE | < 0.0001 |
| Peripheral joint pain/swelling (Q3) | 16 (4–NE) | 32 (12–NE) | 0.0711 |
| Enthesitis (Q4) | 14 (4–NE) | 40 (16–NE) | 0.0017 |
| Morning stiffness (Q5 and Q6)c | 24 (4–NE) | NE | 0.0037 |
| BASDAI total score | 24 (8–NE) | NE | 0.0016 |
| Improvement in ASDAS | |||
| ≥ 1.1 points | 8 (2–NE) | 24 (24–NE) | < 0.0001 |
| ≥ 2.0 points | NE | NE | 0.2494 |
p values based on log–rank tests for differences in survival curves for tofacitinib vs. placebo-to-tofacitinib.
a Switched to open-label tofacitinib at week 16
b Numerical rating scale (0–10)
c Mean of BASDAI Q5 and Q6
AS ankylosing spondylitis, ASDAS Ankylosing Spondylitis Disease Activity Score with C-reactive protein, BASDAI Bath Ankylosing Spondylitis Disease Activity Index, BID twice daily, NE not estimable, Q question.