Table 12.

Comparison of the REFLEX study and other large trials of disease-modifying drugs in patients with a first clinical demyelinating event (19–24)

	Active treatment	Study design	Conversion to CDMS versus placebo	Notes
Comi et al. (19) (REFLEX)	Subcutaneous interferon beta 1-a (44 μg three times a week or once a week)	Primary endpoint, McDonald MS (2005 criteria); secondary endpoint, CDMS	Three times a week, adjusted HR 0.48 (95% CI 0.31–0.73 p<0.0004) once a week, adjusted HR 0.53 (95% CI 0.35–0.79; p=0.0023)	Monofocal presentation, 54%; steroid treatment, 71%
Kapsos et al. (20) (BENEFIT)	Subcutaneous interferon beta 1-b (250 μg every other day)	Primary endpoint, CDMS; secondary endpoint, McDonald MS (2001 criteria)	Adjusted HR 0.50 (95% CI 0.36–0.70; p<0.0001)	Similar conversion to McDonald MS in placebo group; similar risk reduction for McDonald MS and CDMS; monofocal presentation, 53%; steroid treatment, 71%
Jacobs et al. (21) and O’Connor et al. (22) (CHAMPS)	Intramuscular interferon beta-1a (30 μg once a week)	Primary endpoint, CDMS	Rate ratio 0.56 (95% CI 0.38–0.81; p=0.002); adjusted rate ratio 0.49 (95% CI 0.33–0.73; p<0.001)	Monofocal presentation 70%; steroid treatment, 100%
Comi et al. (23) (PRECISE)	Subcutaneous glatiramer acetate (20 mg per day)	Primary endpoint, CDMS	HR 0.55 (95% CI 0.40–0.77; p=0.0005)	Monofocal presentation, 100%; steroid treatment, 61%
Comi et al. (24) (ETOMS)	Subcutaneous interferon beta 1-a (22 μg once a week)	Primary endpoint, CDMS	Odds ratio 0.61 (95% CI 0.37–0.99: p=0.045)	Monofocal presentation, 61%; steroid treatment, 64%

CDMS: clinically definite multiple sclerosis; REFLEX: REbif FLEXible dosing in early MS; HR: hazard ratio; MS: multiple sclerosis