Table 1.

Demographics and efficacy outcome parameters from post-approval reports and from the randomized controlled phase III trials (RCT) ORACLE MS and CLARITY. Real-world evidence (RWE) includes two observational studies and four long-term extension trials. Note that data include patients who were switched to other DMTs following CLAD treatment

	Author (year of publication)	Lizak (2021) [24]	Pfeuffer (2021) [22]	Giovannoni (2021) [26]	Yamout (2020) [28]	Moccia (2020) [27]	Patti (2020) [25]	Leist (2014) [4]	Giovannoni (2010) [5]
	Study design	Observ. registry	Observ. prosp.	Long-term extension	Long-term extension	Long-term extension	Long-term extension	RCT	RCT
Demographics	n =	90	270	98	22	13	80	206	433
	Female (%)	72	61	68	–	69	58	63	69
	Age (mean ± SD)	47 ± 12	39	38 ± 11	–	39 ± 7	39 ± 10	32 ± 9	38 ± 10
	RRMS (%)	78	100	–	–	–	75	35	100
	BL EDSS (median)	5.25	2.0	3.0	–	3.5	–	1.5	Mean: 2.8
	Median follow-up (months)	42	25	60	118	98	73	24	24
Efficacy	Relapse free at 24 months (%)	65	–	–	–	–	85	–	80
	Relapse free at EOS (%)	–	74	–	–	54	57	–	80
	Free of disability prog. at 24 months (%)	80	–	–	–	–	97	–	86
	Free of disability prog. at EOS (%)	–	76	75	86	39	64	–	86
	Therap. switched at EOS (%)	69	–	–	59	69	68	–	–
	Time to next DMT (median, years)	1.7	–	–	–	–	3.8	–	–
	Time to first relapse (months)	–	9	–	–	–	–	–	13
	ARR after CLAD	0.3	–	–	0.2	0.17	0.19	–	0.14
	ARR before CLAD	1.8	1.0	–	–	–	–	–	–

Observ. observational, prosp. prospective, RCT randomized controlled trial, n number of patients included, SD standard deviation, RRMS relapsing remitting multiple sclerosis, BL baseline, EDSS Expanded Disability Status Scale, EOS end of study, DMT disease-modifying therapy, CLAD cladribine, ARR annualized relapse rate, prog. progression, NEDA no evidence of disease activity, IFN interferon, GA glatiramer acetate, DMF dimethyl fumarate, FTY fingolimod, NAT natalizumab, ALEM alemtuzumab