Table 2.

Changes from baseline in patient-reported outcomes for bDMARD-naïve (COAST-V) and TNFi-experienced patients (COAST-W)

Study	Least-squares mean (standard error)
	Week	IXE Q2W	IXE Q4W	ADA	PBO
ASAS treatment response domains
Patient global
COAST-V	8	− 2.4 (0.24)*	− 2.4 (0.24)*	− 2.4 (0.23)*	− 1.1 (0.24)
	16	− 2.8 (0.25)*	− 2.5 (0.25)γ	− 2.6 (0.24)*	− 1.4 (0.24)
COAST-W	8	− 2.3 (0.22)*	− 2.2 (0.20)*	–	− 0.4 (0.21)
	16	− 2.1 (0.24)*	− 2.4 (0.22)*	–	− 0.7 (0.23)
Spinal pain
COAST-V	8	− 2.7 (0.23)*	− 2.8 (0.24)*	− 2.5 (0.23)*	− 1.2 (0.23)
	16	− 3.2 (0.24)*	− 3.2 (0.25)*	− 2.7 (0.23)γ	− 1.7 (0.24)
COAST-W	8	− 2.4 (0.23)*	− 2.3 (0.20)*	–	− 0.6 (0.21)
	16	− 2.5 (0.25)*	− 2.4 (0.23)*	–	− 1.0 (0.24)
Inflammation (BASDAI Q5 and Q6)
COAST-V	8	− 2.6 (0.22)*	− 2.6 (0.22)*	− 2.4 (0.21)*	− 1.2 (0.22)
	16	− 2.9 (0.23)*	− 3.2 (0.24)*	− 2.7 (0.22)*	− 1.3 (0.23)
COAST-W	8	− 2.2 (0.22)*	− 2.2 (0.20)*	–	− 0.4 (0.21)
	16	− 2.4 (0.25)*	− 2.4 (0.23)*	–	− 0.7 (0.24)
Function (BASFI)§
COAST-V	8	− 2.1 (0.20)*	− 2.0 (0.20)*	− 1.9 (0.19)*	− 0.9 (0.20)
	16	− 2.4 (0.22)*	− 2.4 (0.22)*	− 2.1 (0.21)γ	− 1.2 (0.22)
Other outcomes
Spinal pain at night
COAST-V	8	− 2.9 (0.24)*	− 3.1 (0.24)*	− 2.7 (0.23)*	− 1.1 (0.24)
	16	− 3.4 (0.25)*	− 3.6 (0.26)*	− 2.9 (0.24)*	− 1.6 (0.25)
COAST-W	8	− 2.4 (0.24)*	− 2.3 (0.22)*	–	− 0.5 (0.23)
	16	− 2.5 (0.26)*	− 2.6 (0.24)*	–	− 1.0 (0.25)
Fatigue (BASDAI Q1)
COAST-V	8	− 2.0 (0.23)†	− 2.4 (0.23)*	− 2.1 (0.22)γ	− 1.2 (0.22)
	16	− 2.5 (0.24)*	− 2.6 (0.24)*	− 2.3 (0.23)γ	− 1.4 (0.23)
COAST-W	8	− 1.8 (0.21)*	− 1.7 (0.19)*	–	− 0.6 (0.20)
	16	− 2.0 (0.24)*	− 1.9 (0.22)γ	–	− 0.9 (0.23)
Fatigue NRS
COAST-V	8	− 1.7 (0.23)†	− 2.0 (0.23)γ	− 2.1 (0.22)*	− 0.9 (0.22)
	16	− 2.1 (0.24)†	− 2.5 (0.24)γ	− 2.2 (0.23)†	− 1.4 (0.23)
COAST-W	8	− 1.5 (0.23)γ	− 1.8 (0.21)*	–	− 0.5 (0.22)
	16	− 1.7 (0.25)γ	− 2.0 (0.23)*	–	− 0.7 (0.24)
Sleep (JSEQ)
COAST-V	8	− 2.4 (0.42)*	− 2.1 (0.42)γ	− 1.5 (0.40)†	− 0.4 (0.41)
	16	− 3.0 (0.42)†	− 2.5 (0.43)	− 2.7 (0.40)†	− 1.5 (0.41)
COAST-W	8	− 2.0 (0.52)	− 2.6 (0.47)†	–	− 0.9 (0.49)
	16	− 2.4 (0.52)	− 3.0 (0.48)	–	− 1.8 (0.50)
BASDAI§
COAST-V	8	− 2.3 (0.21)*	− 2.4 (0.21)*	− 2.2 (0.20)γ	− 1.3 (0.21)
	16	− 2.7 (0.22)*	− 2.9 (0.22)*	− 2.5 (0.21)*	− 1.4 (0.22)
SF-36 PCS§
COAST-V	8	6.4 (0.74)*	6.5 (0.75)*	6.2 (0.71)*	2.0 (0.73)
	16	8.0 (0.77)*	7.7 (0.78)*	6.9 (0.73)γ	3.6 (0.75)

ADA adalimumab, AS ankylosing spondylitis, ASAS Assessment of Spondyloarthritis International Society, BASDAI Bath Ankylosing Spondylitis Disease Activity Index, BASFI Bath Ankylosing Spondylitis Functional Index, bDMARD biologic disease-modifying antirheumatic drugs, IXE ixekizumab, JSEQ Jenkins Sleep Evaluation Questionnaire, NRS Numeric Rating Scale, PBO placebo, Q2W every 2 weeks, Q4W every 4 weeks, SF-36 PCS Medical Outcomes Study 36-Item Short-Form Health Survey Physical Component Summary, TNFi tumor necrosis factor inhibitor

*p < 0.001 vs PBO; ^γp < 0.01 vs PBO; ^†p < 0.05 vs PBO. Comparisons were performed using a mixed-effects model for repeated measures

^§BASFI, BASDAI, and SF-36 PCS data for TNFi-experienced (COAST-W) patients were published previously [13]