Therapeutic Potential of Ixekizumab in the Treatment of Ankylosing Spondylitis: A Review on the Emerging Clinical Data

Figures & data

Table 1  Percentage of Achievement of the Primary End-Points in Three RCTs of IXE in AS

COAST V at 16 weeks
	Patient N°341	Placebo 87 Pt		ADA 40 mg Q2w 90 Pt	IXE 80 mg Q2w 83Pt	IXE 80 mg Q4w 81 Pt
ASAS40		18		36	52	48
ASAS20		40		59	69	44
BASDAI 50		17		32	43	42
ASDAS<1,3		2		16	11	16
COAST W at 16 weeks
	Patient N°315	Placebo 104 Pt		==	IXE 80 mg q2w 98 Pt	IXE 80 mg q4w 114 Pt
ASAS40		12,5		==	30,6	25,4
ASAS20		29,8		==	46,9	48,2
ASDAS <2,1		4,8		==	17,5	16,3
COAST X at 16–52 weeks
	Patient N°303	Placebo105 Pt.		==	IXE 80 mg q2w 96 Pt.	IXE 80 mg q4w 102 Pt.
ASAS 40 16 weeks		19		==	40	35
ASAS 40 52 weeks		13		==	31	30

Table 2 Percentage of Adverse Events in the 3 RCTs

	COAST V			COAST W				COAST X
	ADA q2W %	IXE q2W %	IXE q4W %	Placebo %	IXE q2W %		IXE q4W %	Placebo %	IXE q2W %		IXE q4W %
TEAE	49	43	42	49	60.2		64	57	77		66
Mild	31	34	27	17.3	23.5		29.8
Moderate	16	7	15	25	32.7		30.7
Severe	2	2	0	6.7	4.1		3.5	4	7		1
Discontinuation due to AE	1	4	0	1.9	3.1		8.8	2	1		1
SAEs	3	1	1	4.8	3.1		3.5	1	1		2
Death	0	0	0	0	1		0	0	0		0
Common TEAE
Nasopharyngitis	7	6	7					8	16		19
Upper respiratory tract infection	2	5	9	2.9	4.1		7.9	4	6		4
AE of interest
Grade 3 or 4 neutropenia	1	0	0	0	0		0.9	1	0		0
Infections	21	20	20	9.6	23.5		29.8	29	42		40
Serious infections	1	1	1	0	0		1.8	0	0		1
Candida infections	1	0	0	0	2		0	1	0		0
Herpes zoster				0	0		0.9	1	0		2
Reactivated tuberculosis	0	0	0	0	0		0	0	0		0
ISR	8	13	4	1	8.2		2.6	7	25		19
Allergic reactions	4	4	4	1	6.1		2.6	4	3		4
Potential anaphylaxis	0	0	0	0	0		0	1	0		0
Hepatic	2	1	1	1.9	1		4.4	6	5		3
Cerebrocardiovascular events	0	0	1	1	1		0	0	1		0
Malignancies	0	0	0	0	0		0.9	0	0		0
Anterior uveitis	0	0	1	0	3.1		1.8	2	2		1
Crohn’s disease	0	1	0	0	0		1.7	0	0		1
Ulcerative colitis	0	0	0	0	0		0.8	1	0		0
Depression	1	0	0	4.8	2		0	0	4		0
Psoriasis	1	0	0	0	0		1

Abbreviations: TEAE, treatment emergent adverse events; AE, adverse events; SAE, serious adverse events; ISR, injection site reactions.