Supplementary Table 4.
Baseline characteristics before and after matching
| Before matching | MEASURE 1/2 after matching | |||||||
|---|---|---|---|---|---|---|---|---|
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|
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| ATLAS | MEASURE 1/2 | Principal analysis | Sensitivity analysis | |||||
| Baseline characteristics | ADA 40 mg n=208 |
Placebo n=107 |
SEC 150 mg n=197 |
Placebo n=196 |
SEC 150 mg ESS=120 |
Placebo ESS=120 |
SEC 150 mg ESS=114 |
Placebo ESS=117 |
| Demographic characteristics used for matching | ||||||||
| Age, years, mean (SD) | 41.7 (11.7) | 43.4 (11.3) | 40.8 (11.9) p=0.4433 |
43.3 (12.7) | 41.7 (9.8) p=1.0000 |
43.4 (9.7) | 41.7 (9.8) p=1.0000 |
43.4 (12.2) |
| Female, n (%) | 51 (24.5) | 28 (26.2) | 67 (34.0) p=0.0356 |
55 (28.1) | (24.5)* p=0.9969 |
(26.2)* | (24.5)* p=0.9969 |
(26.2)* |
| Disease characteristics used for matching | ||||||||
| BASDAI, mean† (SD) | 6.3 (1.7) | 6.3 (1.7) | 6.4 (1.5) p=0.5314 |
6.6 (1.4) | 6.1 (1.2)† p=0.2570 |
6.5 (1.2)† | 6.3 (1.2) p=1.0000 |
6.3 (1.3) |
| BASFI, mean (SD) | 5.2 (2.2) | 5.6 (2.2) | 5.9 (2.2) p=0.0015 |
5.9 (2.0) | 5.2 (1.8) p=1.0000 |
5.6 (1.7) | 5.2 (1.8) p=1.0000 |
5.6 (1.7) |
| CRP, mg/dL, mean (SD) | 1.8 (2.2) | 2.2 (2.9) | 2.0 (3.5) p=0.4891 |
1.6 (2.1) | 1.8 (2.3) p=1.0000 |
2.2 (2.2) | 1.8 (2.3) p=1.0000 |
2.2 (2.2) |
| Previous therapy used for matching‡ | ||||||||
| TNFi-naïve, n (%) | 208 (100) | 107 (100) | 136 (69.0) p<0.0001 |
134 (68.4) | (100)* p=1.0000 |
(100)* | (100)* p=1.0000 |
(100)* |
| Characteristics not used for matching¶ | ||||||||
| BASDAI fatigue item§, mean (SD) | 6.5 (2.0) | 6.7 (1.9) | 6.8 (1.6) | 6.9 (1.7) | 6.5 (1.3) | 6.7 (1.4) | 6.6 (1.2) | 6.5 (1.5) |
| BASMI total score, mean (SD) | 3.8 (2.2) | 4.2 (2.1) | 3.8 (1.8) | 4.0 (1.6) | 3.7 (1.5) | 4.1 (1.3) | 3.7 (1.4) | 4.1 (1.3) |
| Tender joint count, mean (SD) | 5.1 (7.4) | 5.6 (6.8) | 5.5 (7.6) | 5.9 (8.2) | 4.3 (5.7) | 5.3 (5.9) | 4.4 (5.7) | 5.1 (5.7) |
| Swollen joint count, mean (SD) | 1.5 (3.3) | 1.4 (2.8) | 1.9 (3.7) | 2.2 (4.6) | 1.6 (2.8) | 2.0 (3.6) | 1.6 (2.7) | 1.9 (3.4) |
| SF-36 PCS, mean (SD) | 32.9 (8.0) | 31.8 (8.0) | 35.9 (6.8) | 36.3 (6.3) | 37.8 (5.7) | 37.0 (5.2) | 37.6 (5.5) | 37.0 (5.1) |
| SF-36 MCS, mean (SD) | 43.4 (12.0) | 44.4 (12.0) | 39.9 (10.6) | 39.5 (10.4) | 41.6 (8.4) | 40.2 (8.2) | 41.3 (8.4) | 40.6 (8.1) |
| PtGA, mean (SD) | 6.3 (2.2) | 6.5 (2.0) | 6.5 (1.9) | 6.8 (1.8) | 6.2 (1.5) | 6.5 (1.5) | 6.4 (1.5) | 6.4 (1.5) |
| Total back pain, mean (SD) | 6.4 (2.1) | 6.7 (2.2) | 6.5 (1.8) | 6.8 (1.7) | 6.2 (1.5) | 6.7 (1.4) | 6.4 (1.4) | 6.6 (1.4) |
| Nocturnal pain, mean (SD) | 6.1 (2.4) | 6.5 (2.4) | 6.3 (1.9) | 6.5 (2.0) | 6.0 (1.5) | 6.6 (1.4) | 6.2 (1.4) | 6.5 (1.4) |
| ASQoL, mean (SD) | 10.2 (4.0) | 10.6 (4.0) | 11.3 (4.5) | 11.6 (4.2) | 10.3 (3.9) | 11.3 (3.7) | 10.4 (3.9) | 11.2 (3.7) |
| Corticosteroid use, mean (%) | 25 (12.0) | 6 (5.6) | 22 (11.2) | 23 (11.7) | (12.5)* | (14.0)* | (11.2)* | (14.5)* |
Integer population (n) values not available owing to calculation of pooled SEC ESS using the equation:
BASDAI scores were not included in the matching for the principal analysis, but were included in the sensitivity analysis
TNFi-experienced patients in MEASURE 1 and MEASURE 2 are TNFi-inadequate responders
This score is based on a question on fatigue from the BASDAI
Duration of AS was also identified as a relevant factor, but this could not be matched because it was defined as time from diagnosis in MEASURE 1/2 and time from symptom onset in ATLAS
All p values were calculated for secukinumab vs. adalimumab
ADA: adalimumab, ASQoL: Ankylosing Spondylitis Quality of Life, BASDAI: Bath Ankylosing Spondylitis Disease Activity Index, BASFI: Bath Ankylosing Spondylitis Functional Index, BASMI: Bath Ankylosing Spondylitis Metrology Index, CRP: C-reactive protein, ESS: effective sample size, MCS: Mental Component Summary, PCS: Physical Component Summary, PtGA: patient global assessment, SD: standard deviation, SEC: secukinumab, SF-36: 36-item Short-Form Health Survey, TNFi: tumor necrosis factor inhibitor