A pharmacogenetic signature of high response to Copaxone in late-phase clinical-trial cohorts of multiple sclerosis

Table 4 Summary of ARR change based on predicted response

Cohort	Type of MS	Number of patients			Follow-up duration (years)	Mean ARR change: Sig + versus Sig−
Cohort		Total	Sig+	Sig−	Follow-up duration (years)	Mean ARR change: Sig + versus Sig−
Discovery
GALA DB	RRMS	639	323	316	1	−54%
FORTE DB	RRMS	532	268	264	1	−64%
Independent assessment
GALA OL	RRMS	333	190	143	~3	−14%
GA-9001 DB		38	21	17	~3	−13%
GA-9001 OL		74	35	39	~20	−22%
GA-9003 DB		40	21	19	0.75	−53%
GA-9003 OL		84	41	43	0.75	−49%
PreCISe DB	CIS	132	69	63	3	−5%
PreCISe OL	CIS	240	129	111	5	+14%
Specificity assessment
BRAVO – Avonex	RRMS	310	176	134	2	+10%

Sig + (signature-positive) and sig − (signature-negative) indicate patients classified as relapse-free and relapsing, respectively, after applying the “top-left” threshold on the predicted probabilities from the four-SNP logistic regression model (see “Methods”). Mean ARR was calculated by dividing the total number of relapses in Sig + (or Sig−) patients by the total sum of exposure to Copaxone (in years). The difference between mean ARR of Sig + and Sig − patients is presented in the last column. ARR annualized relapse rate, CIS clinically isolated syndrome, DB double-blind phase, OL open-label phase, RRMS relapsing-remitting multiple sclerosis

ISSN: 1756-994X