Effectiveness endpoints of the main analysis using the FiRST definition for fibromyalgia
| Effectiveness endpoint | All patients n=508 (%) | Fibromyalgia† | Crude OR (95% CI)‡ | P value* | Adjusted OR (95% CI)§ | P value | |
| Yes n=192 (%) | No n=316 (%) | ||||||
| BASDAI response¶ | 258/508 (50.8) | 87/192 (45.3) | 171/316 (54.1) | 0.7 (0.5 to 1.0) | NS | 0.7 (0.5 to 1.1) | NS |
| ASAS 40 | 201/508 (39.6) | 55/192 (28.6) | 146/316 (46.2) | 0.5 (0.3 to 0.7) | <0.001 | 0.5 (0.3 to 0.8) | 0.001 |
| ASAS 20 | 268/508 (52.8) | 83/192 (43.2) | 185/316 (58.5) | 0.5 (0.4 to 0.8) | <0.001 | 0.6 (0.4 to 0.9) | 0.008 |
| ASDAS MI | 117/508 (23.0) | 36/192 (18.7) | 81/316 (56.3) | 0.7 (0.4 to 1.0) | NS | 0.8 (0.5 to 1.3) | NS |
| ASDAS CII | 265/508 (52.2) | 87/192 (45.3) | 178/316 (56.3) | 0.6 (0.5 to 0.9) | 0.02 | 0.7 (0.5 to 1.1) | NS |
| ΔNSAID score ≥50% | 235/508 (46.3) | 69/192 (35.9) | 166/316 (52.5) | 0.5 (0.4 to 0.7) | <0.001 | 0.6 (0.4 to 0.8) | 0.003 |
| ΔCRP >0 mg/L | 325/508 (64.0) | 112/192 (58.3) | 213/316 (67.4) | 0.7 (0.5 to 1.0) | NS | 0.7 (0.5 to 1.2) | NS |
| ASDAS MDA at 12 weeks | 264/508 (52.0) | 74/192 (38.5) | 190/316 (60.1) | 0.4 (0.3 to 0.6) | <0.001 | 0.5 (0.3 to 0.7) | <0.001 |
| ASDAS ID at 12 weeks | 126/508 (24.8) | 28/192 (14.6) | 98/316 (31.0) | 0.4 (0.2 to 0.6) | <0.001 | 0.4 (0.3 to 0.7) | <0.001 |
| NSAID score ≤10 at 12 weeks | 401/508 (78.9) | 140/192 (72.9) | 261/316 (82.6) | 0.6 (0.4 to 0.9) | 0.01 | 0.6 (0.4 to 0.9) | 0.02 |
| CRP <6 mg/L at 12 weeks | 392/508 (77.2) | 145/192 (75.5) | 247/316 (78.2) | 0.9 (0.6 to 1.3) | NS | 0.7 (0.5 to 1.2) | NS |
*Statistical significance was established for P<0.05.
†Fibromyalgia according to the FiRST questionnaire.
‡Crude OR: result of the univariable analysis.
§Adjusted OR for age (below 40), gender (male), past or present X-ray sacroiliitis, past or present MRI sacroiliitis, abnormal CRP, smoking status, HLA B27 and absence of previous TNFb exposure.
¶Data in the table are presented as number and (%).
ASAS, Assessment in SpondyloArthritis international Society; ASDAS, Ankylosing Spondylitis Disease Activity Score; ASDAS CII, ASDAS clinically important improvement; ASDAS ID, ASDAS inactive disease; ASDAS MDA, ASDAS minimal disease activity; ASDAS MI, ASDAS major improvement; BASDAI, Bath Ankylosing Spondylitis Disease Activity Score; CRP, C reactive protein; FiRST, Fibromyalgia Rapid Screening Tool; NSAID, non-steroidal anti-inflammatory drugs; TNFb, tumour necrosis factor blockers.