Table 1.

Biological DMARD trials in nr-axSpA

Drug	Drug mechanism	Inclusion criteria	Patient no. (active/placebo)	Primary endpoint	ASAS40 outcome active/placebo (%)	LDA/remission rate
Adalimumab (56)	TNF inhibitor	2009 ASAS axSpA criteria but not meet AS criteria No restriction on disease duration BASDAI ≥ 4 Total back pain ≥ 4	91/94	ASAS40 response at week 12	36%/15%
Golimumab (55)	TNF inhibitor	2009 ASAS axSpA criteria but not meet AS criteria Disease duration ≤ 5 years BASDAI ≥ 4 Total back pain ≥ 4	98/100	ASAS20 response at week 16	57%/23%
Certolizumab (58)	TNF inhibitor	2009 ASAS axSpA criteriaa BASDAI ≥ 4 Total back pain ≥ 4 No restriction on disease duration Elevated CRP or ASAS/OMERACT MRI changes	147a/107	ASAS 20 response at week 12	47–48%/16%
Etanercept (57)	TNF inhibitor	2009 ASAS axSpA criteria but not meet AS criteria. Disease duration > 3 months and < 5 years BASDAI ≥ 4	106/109	ASAS40 response at week 12	32%/16%

CRP C-reactive protein, MRI magnetic resonance imaging; ‘ASAS/OMERACT MRI’ MRI changes meeting the ASAS/OMERACT definition of sacroiliitis, BASDAI Bath Ankylosing Spondylitis Disease Activity Index, LDA low disease activity

^aThis trial included both AS and nr-axSpA, but only the nr-axSpA results are reported in the table