Table 6

Trials with an active comparator in patients with axSpA

Study	Study design	Types of patients	Treatment groups	N patients	Time point (weeks)	ASAS20 (%)	p Value	ASAS40 (%)	p Value	Risk of bias
Giardina et al50	RCT open-label	r-axSpA* TNFi-naïve	INF 5 mg/Kg Q6W IV	25	12	75	NS	55	NS	High
Giardina et al50	RCT open-label	r-axSpA* TNFi-naïve	ETA 50 mg QW SC	25	12	60	REF	43	REF	High
Braun et al 51 (ASCEND)	RCT double-blind	r-axSpA* TNFi-naïve	ETA 50 mg QW SC	379	16	75.9	<0.001	59.8	<0.001	Low
Braun et al 51 (ASCEND)	RCT double-blind	r-axSpA* TNFi-naïve	SSZ 3g/day oral	187	16	52.9	REF	32.6	REF	Low
Song et al 52 (ESTHER)	RCT open-label	axSpA† TNFi-naïve	ETA 25 mg BiW SC	40	48	85	0.001	70	0.001	Unclear
Song et al 52 (ESTHER)	RCT open-label	axSpA† TNFi-naïve	SSZ 2–3g/day oral	36	48	42	REF	31	REF	Unclear
Park et al 58 (PLANETAS)	RCT double-blind (non-inferiority trial)	r-axSpA* TNFi-naïve	CT-P13 5 mg/Kg Q6W IV	125	30	70.5	–	51.8	–	Low
Park et al 58 (PLANETAS)	RCT double-blind (non-inferiority trial)	r-axSpA* TNFi-naïve	INF 5 mg/Kg Q6W IV	125	30	72.4	–	47.4	–	Low
Sieper et al 55 (INFAST-1)	RCT double-blind	axSpA† TNFi-naïve not refractory to NSAIDs	INF 5 mg/Kg+NPX	105	28	81.0	0.30	75.2	0.03	Low
Sieper et al 55 (INFAST-1)	RCT double-blind	axSpA† TNFi-naïve not refractory to NSAIDs	PBO+NPX	51	28	72.5	REF	56.9	REF	Low
Viapiana et al 57	CCT open-label	r-axSpA*	INF 5 mg/Kg Q6W IV	30	24	69	NS	45	NS	High
Viapiana et al 57	CCT open-label	TNFi-naïve	Neridronate 100 mg Q4W IV	30	24	68	REF	39	REF	High
Mok et al 56	RCT open-label	axSpA† TNFi-naïve	GOL 50 mg Q4W SC	20	48	65	NS	35	NS	Unclear
Mok et al 56	RCT open-label	axSpA† TNFi-naïve	PAM 60 mg Q4W IV	9	48	56	REF	11	REF	Unclear

*According to the modified New York criteria.
†According to the ASAS axSpA criteria.
axSpA, axial spondyloarthritis; CCT, controlled clinical trial; ETA, etanercept; GOL, golimumab; INF, infliximab; IV, intravenous; NA, not applicable; NPX, naproxen; NS, non-significant (p>0.05); NSAIDs, Nonsteroidal anti-inflammatory drug; PAM, pamidronate; PBO, placebo; Q4W, every 4 weeks; Q6W, every 6 weeks; QW, every week; r-axSpA, radiographic axial spondyloarthritis; RCT, randomised controlled trial; REF, reference; SC, subcutaneous; SSZ, sulfasalazine; TNFi, tumour necrosis factor inhibitor.