Table 1.

Seminal randomized controlled clinical trials evaluating the efficacy of TNFis in patients with AS

Generic name	Trial	Main inclusion criteria	Number of patients in active arm/ comparator arm	Primary endpoint	Primary endpoint vs PBO	References
Adalimumaba	ATLAS	Active AS, inadequate response to glucocorticoids, NSAIDs, analgesics, MTX or SSZ	208/107	ASAS 20 at week 12 vs PBO	58.2 vs 20.6%	[5]
Certolizumab pegolb	RAPID-axSpA	Active AS and nr-axSpA, elevated CRP levels and/or sacroiliitis on MRI, inadequate response to one or more NSAIDs	111 (200 mg Q2W) 107 (400 mg Q4W)/107	ASAS 20 at week 12 vs PBO	57.7% (200 mg Q2W) 63.6% (400 mg Q4W) vs 38.3%	[1]
Etanercepta	Enbrel AS study group trial	Active AS	138/139	ASAS 20 at week 12 vs PBO	57 vs 22%	[37]
Golimumaba	GO-RAISE	Active AS with inadequate response to NSAIDs or DMARDs	138 (50 mg Q4W) 140 (100 mg Q4W)/78	ASAS 40 at week 14 vs PBO	59.4% (50 mg Q2W) 60.0% (100 mg Q4W) vs 21.8%	[38]
Infliximab	ASSERT	Active AS, normal chest radiograph, negative for latent tuberculosis	201/78	ASAS 20 at week 24 vs PBO	61.2 vs 19.2%	[39]
In patients with early/nr-axSpA
Infliximab	—	Recent-onset inflammatory back pain, HLA-B27-positive, MRI evidence of sacroiliitis	20/20	Change in total MRI score at week 16 vs PBO	−2.0 vs 0.0	[40]
Etanercept	ESTHER	Diagnosis of axSpA with symptom duration of <5 years, good or very good response to NSAIDs	40/36	Change in active inflammatory lesions in the SI joints and spine detected by MRI at week 48 vs SSZ	−5.7 vs −1.9	[11]
Infliximab	INFAST (part 1)	Moderate to severe active axSpA with disease duration ≤3 years, not refractory to NSAIDs	105/51	ASAS partial remission at week 28 vs PBO	61.9 vs 35.5%	[12]
Adalimumab	—	Active axSpA without radiographically defined sacroiliitis, refractory to NSAIDs	22/24	ASAS 40 at week 12 vs PBO	54.5 vs 12.5%	[43]

Data taken from references 1, 5, 37–43. These data do not come from a direct head-to-head comparison. These data are from the pivotal placebo-controlled studies for each biologic listed; the study design, including inclusion/exclusion criteria and baseline characteristics may be different. ^aAll patients enrolled into these trials had not received any anti-TNF therapy before randomization. ^bIn addition to patients with AS (n = 178), patients with nr-axSpA (n = 147) were included in this trial; combined results were presented in this trial. ASAS: Assessment of SpondyloArthritis International Society; axSpA: axial spondyloarthritis; PBO: placebo; Q2W: every 2 weeks; Q4W: every 4 weeks.