Golimumab — a new tool in the armoury against inflammatory arthritis

Figures & data

Table I. Phase III studies in rheumatoid arthritis.

Name of study	Ref.	Disease stage	Treatment	Number of patients	Primary outcome	Result for primary outcome, n (%)		Primary outcome met?	Radiographic results
	(15)	MTX IR	iv PBO + po MTX	129	ACR50 response at week 14	17 (13.2)		No	ND
			iv GLM 2 mg/kg + po MTX	129		16 (12.5)
			iv GLM 2 mg/kg + po PBO	128		25 (19.4)
			iv GLM 4 mg/kg + po MTX	128		28 (21.7)
			iv GLM 4 mg / kg + po PBO	129		27 (21.1)
			Combined golimumab groups	514		96 (18.7)
GO-BEFORE	(16,17)	MTX naive	PBO sc + MTX	160	ACR50 response at week 24	47 (29.4)		No	Significant reduction in radiographic progression with GLM
			GLM 100 mg sc + PBO	159		52 (32.7)
			GLM 50 mg sc + MTX	159		64 (40.3)
			GLM 100 mg sc + MTX	159		58 (36.5)
			Combined GLM + MTX groups	318		122 (38.4)
GO-FORWARD	(17–19)	MTX IR			ACR20 response at week 14 and improvement in HAQ-DI at week 24	ACR20	HAQ-DI	Yes	No significant difference
			PBO sc + MTX	133		44 (33.1)	−0.13
			GLM 100 mg sc + PBO	133		59 (44.4)	−0.13
			GLM 50 mg sc + MTX	89		49 (55.1)	−0.38
			GLM 100 mg sc + MTX	89		50 (56.2)	−0.50
			Combined GLM + MTX groups	178		99 (55.6)	−0.44
GO-AFTER	(20)	TNF IR	PBO	155	ACR20 response at week 14	28 (18%)		Yes	ND
			GLM 50 mg	153		54 (35%)
			GLM 100 mg	153		58 (38%)
			Combined GLM groups	306		112 (37%)

ACR response = American College of Rheumatology % improvement criteria; GLM = golimumab; HAQ-DI = health assessment questionnaire disability index; IR = inadequate response; iv = intravenous; MTX = methotrexate; ND = not done; PBO = placebo; po = oral; sc = subcutaneous; TNF = tumour necrosis factor.

Table II. Phase III studies in the spondyloarthropathies.

Name of study	Ref.	Disease	Treatment	Number of patients	Primary outcome	Result for primary outcome, n (%)	Primary outcome met?	Radiographic results
GO-REVEAL	(21,22)	PsA	Placebo	113	ACR20 response at week 14	10 (9)	Yes	Significant reduction in radiographic progression with GLM
			GLM 50 mg	146		74 (51)
			GLM 100 mg	146		66 (45)
			Combined GLM group	292		140 (48)
GO-RAISE	(24,25)	AS	Placebo	78	ASAS20 response at week 14	(21.8)	Yes	ND
			GLM 50 mg	138		(59.4)
			GLM 100 mg	140		(60.0)

ACR20 response = American College of Rheumatology 20% improvement criteria; AS = ankylosing spondylitis; ASAS20 response = ASessment in AS International Working Group criteria; GLM = golimumab; ND = not done; PsA = psoriatic arthritis.

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