Table 2.
Study outcomesa
| Placebo plus NBBM group (n = 158) | CZP plus NBBM group (n = 159)b | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Week 12, observed case analysis | Week 12, imputed | Week 52, observed case analysis | Week 52, imputed | Baseline | Week 12, observed case analysis | Week 12, imputed | Week 52, observed case analysis | Week 52, imputed | |
| Hierarchy outcome measure | ||||||||||
| ASDAS‐MI, no./total no. (%)c | 0.0 | 10/155 (6.5) | 10/158 (6.3) | 11/51 (21.6) | 11/158 (7.0) | 0.0 | 56/155 (36.1) | 56/159 (35.2) | 75/121 (62.0) | 75/159 (47.2) |
| ASAS40, no./total no. (%)c | 0.0 | 18/155 (11.6) | 18/158 (11.4) | 25/51 (49.0) | 25/158 (15.8) | 0.0 | 76/155 (49.0) | 76/159 (47.8) | 90/121 (74.4) | 90/159 (56.6) |
| BASDAI score, mean ± SD (total no.)d | 6.79 ± 1.28 (158) | 5.68 ± 2.08 (155) | 5.71 ± 2.09 (158) | 3.47 ± 1.73 (51) | 5.47 ± 2.30 (158) | 6.88 ± 1.40 (159) | 3.89 ± 2.19 (155) | 3.93 ± 2.21 (157) | 2.64 ± 2.08 (121) | 3.26 ± 2.47 (157) |
| BASFI score, mean ± SD (total no.)d | 5.44 ± 2.18 (158) | 4.89 ± 2.44 (155) | 4.95 ± 2.46 (158) | 2.88 ± 1.94 (51) | 4.71 ± 2.60 (158) | 5.41 ± 2.12 (158) | 3.19 ± 2.34 (155) | 3.20 ± 2.33 (157) | 2.13 ± 2.09 (121) | 2.68 ± 2.42 (157) |
| SPARCC SI joint score, mean ± SD (total no.) | 8.46 ± 12.31 (153) | 8.43 ± 12.39 (139) | – | 5.84 ± 10.99 (46) | – | 7.79 ± 10.82 (154) | 2.81 ± 5.44 (138) | – | 1.92 ± 3.96 (110) | – |
| Nocturnal spinal pain (NRS), mean ± SD (total no.)d | 6.6 ± 2.1 (158) | 5.5 ± 2.6 (155) | 5.6 ± 2.6 (158) | 3.5 ± 2.4 (51) | 5.4 ± 2.8 (51) | 6.6 ± 2.3 (158) | 3.3 ± 2.6 (155) | 3.4 ± 2.7 (157) | 2.0 ± 2.1 (121) | 2.7 ± 2.7 (157) |
| ASQoL score, mean ± SD (total no.)d | 12.11 ± 4.25 (158) | 10.52 ± 5.18 (155) | 10.61 ± 5.17 (158) | 6.76 ± 5.14 (51) | 10.34 ± 5.47 (158) | 11.70 ± 4.34 (158) | 6.70 ± 5.47 (155) | 6.67 ± 5.45 (157) | 4.14 ± 4.67 (121) | 5.38 ± 5.42 (157) |
| Uveitis | ||||||||||
| Patients with flares, no./total no. (%)c | 11/158 (7.0) | – | NA | 8/158 (5.1) | NA | 6/159 (3.8) | – | NA | 4/159 (2.5) | NA |
| EAIR, 95% CIe | – | – | NA | 7.21 (3.11–14.20) | NA | – | – | NA | 2.50 (0.68–6.39) | NA |
| Additional outcome measures | ||||||||||
| SF‐36 PCS, mean ± SD (total no.)d | 33.7 ± 7.0 (157) | 36.1 ± 7.8 (155) | 35.9 ± 7.8 (157) | 42.2 ± 6.7 (51) | 37.0 ± 8.2 (157) | 34.6 ± 7.1 (157) | 42.6 ± 8.5 (155) | 42.6 ± 8.5 (157) | 47.4 ± 7.8 (121) | 44.9 ± 9.5 (157) |
| SF‐36 MCS, mean ± SD (total no.)d | 41.2 ± 10.1 (157) | 43.3 ± 10.8 (155) | 43.2 ± 10.8 (157) | 47.8 ± 11.2 (51) | 42.7 ± 11.4 (157) | 42.0 ± 11.0 (157) | 46.3 ± 10.5 (155) | 46.4 ± 10.5 (157) | 48.2 ± 10.4 (121) | 47.2 ± 10.8 (157) |
| EQ‐5D, mean ± SD (total no.)d | 44.6 ± 19.9 (157) | 53.5 ± 21.7 (155) | 53.3 ± 21.7 (157) | 65.5 ± 18.0 (51) | 53.4 ± 22.4 (157) | 47.7 ± 20.1 (157) | 65.1 ± 18.5 (155) | 65.0 ± 18.5 (157) | 74.2 ± 18.3 (121) | 68.4 ± 22.0 (157) |
| ASAS‐NSAID score, mean ± SD (total no.)d | 66.3 ± 48.7 (158) | 65.8 ± 49.3 (147) | 65.1 ± 49.0 (158) | 56.5 ± 59.0 (48) | 63.4 ± 50.3 (158) | 69.6 ± 48.0 (159) | 63.7 ± 48.2 (153) | 62.8 ± 48.4 (158) | 52.7 ± 50.7 (109) | 52.3 ± 50.4 (158) |
| CRP, mean ± SD (total no.)d | 15.8 ± 17.7 (158) | 13.2 ± 17.2 (155) | 14.6 ± 23.9 (158) | 8.7 ± 10.8 (51) | 12.9 ± 21.8 (158) | 15.8 ± 17.8 (159) | 6.7 ± 15.1 (154) | 6.6 ± 15.0 (157) | 6.2 ± 15.6 (122) | 6.1 ± 14.0 (157) |
| BASMI, mean ± SD (total no.)d | 2.80 ± 1.40 (156) | 2.73 ± 1.36 (151) | 2.75 ± 1.41 (156) | 2.47 ± 1.16 (47) | 2.80 ± 1.39 (158) | 2.96 ± 1.29 (157) | 2.58 ± 1.37 (148) | 2.55 ± 1.35 (154) | 2.12 ± 1.25 (116) | 2.37 ± 1.36 (156) |
| MASES, mean ± SD (total no.)d | 4.8 ± 3.5 (122) | 4.4 ± 3.7 (119) | 4.4 ± 3.7 (122) | 2.2 ± 3.1 (36) | 4.3 ± 3.8 (122) | 4.8 ± 3.2 (125) | 2.7 ± 3.4 (122) | 2.7 ± 3.4 (123) | 1.3 ± 2.2 (91) | 2.1 ± 3.1 (123) |
NBBM = nonbiologic background medication; ASDAS‐MI = major improvement in Ankylosing Spondylitis Disease Activity Score; ASAS40 = achievement of 40% improvement according to the Assessment of SpondyloArthritis international Society criteria; BASDAI = Bath Ankylosing Spondylitis Disease Activity Index (0–10 scale; higher scores indicate higher disease activity); BASFI = Bath Ankylosing Spondylitis Functional Index (0–10 scale; higher scores indicate worse function); SPARCC = Spondyloarthritis Research Consortium of Canada; SI = sacroiliac; NRS = numeric rating scale; ASQoL = ankylosing spondylitis quality of life (0–18 scale; higher scores indicate worse quality of life); NA = not applicable; EAIR = exposure‐adjusted incidence rate; 95% CI = 95% confidence interval; SF‐36 = Short Form 36 health survey (0–100 scale; higher scores indicate better quality of life); PCS = physical component summary score; MCS = mental component score; EQ‐5D: EuroQol 5‐domain questionnaire (0–100 scale; higher scores indicate better health status); ASAS‐NSAID score = ASAS–nonsteroidal antiinflammatory drug score (0–100 scale; higher scores indicate greater NSAID intake); CRP = C‐reactive protein; BASMI = Bath Ankylosing Spondylitis Metrology Index (0–10 scale; higher scores indicate more severe spinal mobility impairment); MASES = Maastricht Ankylosing Spondylitis Enthesitis Score (0–13 scale; higher scores indicate more severe enthesitis).
This treatment group received certolizumab pegol (CZP) 200 mg every other week.
Imputed using nonresponder imputation.
Imputed using last observation carried forward.
Exposure per 100 subject‐years.