Table 1.
Characteristics of the studies included in the systematic literature review
| Rudwaleit RHAPSODY | Lie NOR-DMARD |
Paccou (France) |
Pavelka ATTRA | Glintborg DANBIO |
Gulyas (Hungary) |
Heinonen ROB-FIN |
Ciurea SCQM |
Braun MEASURE 1 and 2 |
|
| Study | |||||||||
| Year | 2010 | 2011 | 2011 | 2012 | 2013 | 2014 | 2015 | 2016 | 2016 |
| Journal |
Arthritis Research
and Therapy |
Annals of
Rheumatic Diseases |
Rheumatology | Reumatologia |
Annals of
Rheumatic Diseases |
Eur J Health Econ | J Rheumatol |
Arthritis Research
and Therapy |
Expert Opin Biol Ther |
| Design | Open-label trial, multicentre | Prospective, observational, multicentre | Retrospective, observational, multicentre | Prospective, observational, single-centre | Prospective, observational, multicentre | Retrospective, observational, single-centre | Retrospective, observational, multicentre | Retrospective, observational, multicentre | Post-hoc from 2 RCTs |
| Patients | |||||||||
| Type of axSpA | AS | AS | AS | AS | AS | AS | AS | axSpA | AS |
| First bDMARD (control group) | 924 | 437 | 267 | 1012 | 773 | 98 | 543 | – | 137 |
| Second bDMARD | 326 | 77 | 75 | 163 | 432 | 77 | 123 | 632 | 51 |
| Third bDMARD | 22 | 137 | 11 | ||||||
| Drug | |||||||||
| First bDMARD | IFX (50%), ETN (26%), IFX and ETN (24%) |
ETN (51%), IFX (35%), ADA (14%) |
ETN (54%), IFX (38%), ADA (8%) |
ETN (34%), IFX (32%), ADA (31%), GOL (3%) |
ADA (45%), IFX (37%), ETN (16%), GOL (1%) |
IFX (39%), ETN (33%), ADA (23%), GOL (5%) |
ETN (48%), ADA (29%), IFX (23%) |
TNFi | TNFi |
| Second bDMARD | ADA (100%) | ETN (40%), ADA (36%), IFX (24%) |
ADA (56%), ETN (32%), IFX (22%) | IFX (47%), ETN (33%), ADA (18%), GOL (3%) |
ADA(46%), ETN (40%), IFX (10%), GOL (3%) |
ADA (56%), GOL (22%), IFX (12%), ETN (10%) |
ADA (59%), ETN (33%), IFX (8%) |
TNFi | Secukinumab |
| Third bDMARD | TNFi | ADA (31%), ETN (29%), IFX (27%), GOL (7%), CZP (2%) |
GOL (55%), ADA (27%), ETN (18%) |
||||||
| Outcome | |||||||||
| Follow-up (months) | 3 | 12 | 3 | 6 | 6 | 3 | 6 | 12 | 4 |
| Response measure | ASAS40, BASDAI50, ΔBASDAI |
ASAS20, ASAS40, BASDAI50, ΔASDAS≥1.1, ΔASDAS≥2.0 |
BASDAI50, ΔBASDAI≥2, expert opinion, ΔBASDAI |
BASDAI<4 | BASDAI50Δ20mm, ΔBASDAI, ΔCRP |
BASDAI50, ΔBASDAI |
BASDAI50, ΔASDAS≥1.1, ΔASDAS≥2.0 |
ASDAS<1.3, ASDASpr |
ASAS20, ASAS40, ΔBASDAI |
| Level of evidence | |||||||||
| CEBM Oxford | 2b | 4 | 4 | 4 | 4 | 4 | 4 | 4 | 2b |
ADA, adalimumab; AS, ankylosing spondylitis; ASAS, Assessment of SpondyloArthritis international Society; ASDAS, Ankylosing Spondylitis Disease Activity Score; ATTRA, anti TNF-α terapie revmatoidní artritidy; axSpA, axial spondyloarthritis; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; bDMARD, biological disease-modifying antirheumatic drugs; CEBM, Centre for Evidence-Based Medicine; CRP, C reactive protein; CZP, certolizumab pegol; DANBIO, Danish nationwide registry; ETN, etanercept; IFX, infliximab; GOL, golimumab; RCT, randomised controlled trial; MEASURE, Efficacy, Safety, and Tolerability of Secukinumab in Active Ankylosing Spondylitis Patients; NOR-DMARD, Norwegian Antirheumatic Drug Register; RHAPSODY, Review of Safety and Effectiveness witH Adalimumab in Patients with Active Ankylosing SpOnDYlitis; ROB-FIN, Finnish Register of Biological Treatment SCQM: Swiss Clinical Quality Management in Rheumatic Diseases; TNFi, tumour necrosis factor inhibitor.