Efficacy of tofacitinib 5 mg two times per day versus placebo at week 16: secondary endpoints without type I error control
| Tofacitinib 5 mg two times per day (N=133) | Placebo (N=136) | |
| ASAS partial remission rate,† n (%) | 20 (15.0)*** | 4 (2.9) |
| ASAS 5/6 response rate,† n (%) | 58 (43.6)*** | 10 (7.4) |
| ASDAS clinically important improvement response rate,†‡ n (%) (N1) | 81 (61.4) (132)*** | 26 (19.1) (136) |
| ASDAS major improvement response rate,†§ n (%) (N1) | 37 (30.1) (123)*** | 6 (4.7) (129) |
| ASDAS LDA rate,†¶ n (%) (N1) | 51 (38.9) (131)*** | 11 (8.1) (136) |
| ASDAS inactive disease rate,†** n (%) (N1) | 9 (6.8) (133)** | 0 (0.0) (136) |
| BASDAI50 response rate,† n (%) | 57 (42.9)*** | 24 (17.7) |
| ∆BASDAI,†† LSM (SE) (N2) | −2.55 (0.18) (129)*** | −1.11 (0.17) (131) |
| ∆MASES,††‡‡ LSM (SE) (N2) | −1.94 (0.29) (70) | −1.41 (0.27) (76) |
| ∆SJC(44),††§§ LSM (SE) (N2) | −3.35 (0.48) (33) | −2.79 (0.47) (36) |
Data are from the week 16 analysis: data cut-off 19 December 2019; data snapshot 29 January 2020.
**p<0.01, ***p<0.001 for comparing tofacitinib 5 mg two times per day versus placebo.
†Normal approximation adjusting for the stratification factor (bDMARD treatment history: bDMARD-naïve versus TNFi-IR or prior bDMARD use without IR) derived from the clinical database via the Cochran-Mantel-Haenszel approach was used. Missing response was considered as non-response.
‡Analysed in patients with baseline ASDAS ≥1.736.
§Analysed in patients with baseline ASDAS ≥2.636.
¶Analysed in patients with baseline ASDAS ≥2.1.
**Analysed in patients with baseline ASDAS ≥1.3.
††Mixed model for repeated measures included fixed effects of treatment group, visit, treatment group by visit interaction, stratification factor derived from the clinical database, stratification factor by visit interaction, baseline value, and baseline value by visit interaction. The model used a common unstructured variance-covariance matrix, without imputation for missing values.
‡‡Analysed in patients with baseline MASES >0.
§§Analysed in patients with baseline SJC(44) >0.
Δ, change from baseline; ASAS, Assessment of SpondyloArthritis international Society; ASDAS, Ankylosing Spondylitis Disease Activity Score using hsCRP; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; bDMARD, biologic disease-modifying antirheumatic drug; hsCRP, high-sensitivity C-reactive protein; IR, inadequate response or intolerance; LDA, low disease activity; LSM, least squares mean; MASES, Maastricht Ankylosing Spondylitis Enthesitis Score; N, number of patients in full analysis set; N1, number of patients who met the baseline ASDAS inclusion criterion for the analysis; N2, number of patients with observation at week 16; n, number of patients with response; SJC(44), swollen joint count based on 44 joints; TNFi, tumour necrosis factor inhibitor.