Table 1.
Median time to initial 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 | 4 (2–16) | 24 (4–40) | < 0.0001 |
| Nocturnal painb | 4 (2–24) | 24 (8–32) | 0.0003 |
| ≥ 50% improvement | |||
| Total back painb | 8 (4–48) | 32 (16–NE) | 0.0001 |
| Nocturnal painb | 8 (4–40) | 24 (16–NE) | < 0.0001 |
| BASDAI questions | |||
| Fatigue (Q1) | 24 (4–NE) | 32 (12–NE) | 0.0895 |
| Spinal pain (Q2) | 8 (4–NE) | 32 (12–NE) | < 0.0001 |
| Peripheral joint pain/swelling (Q3) | 10 (2–NE) | 24 (4–NE) | 0.2070 |
| Enthesitis (Q4) | 8 (4–48) | 24 (8–NE) | 0.0250 |
| Morning stiffness (Q5 and Q6)c | 12 (4–NE) | 32 (24–NE) | 0.0091 |
| BASDAI total score | 12 (4–NE) | 32 (16–NE) | 0.0002 |
| Improvement in ASDAS | |||
| ≥ 1.1 points | 4 (2–20) | 24 (12–40) | < 0.0001 |
| ≥ 2.0 points | NE | NE | 0.0361 |
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.