Results from the 5-year, phase IV RENEW (Registry to Evaluate Novantrone Effects in Worsening Multiple Sclerosis) study

Table 2 RENEW treatment discontinuations

	Overall	Type of MS
		Worsening	PRMS	SPMS
		RRMS
Patients enrolled^a	509	81	33	395
Discontinued treatment, n (%)	486 (95.5)	74 (91.4)	32 (97.0)	380 (96.2)
Death^b	4 (0.8)	1 (1.2)	0	3 (0.8)
Other adverse event	14 (2.8)	2 (2.5)	2 (6.1)	10 (2.5)
Physician decision	146 (28.7)	28 (34.6)	6 (18.2)	112 (28.4)
Reached maximum cumulative dose (≥140 mg/m²)^c	23 (4.5)	5 (6.2)	1 (3.0)	17 (4.3)
Lack of efficacy	16 (3.1)	0	2 (6.1)	14 (3.5)
Lost to follow-up	40 (7.9)	3 (3.7)	2 (6.1)	35 (8.9)
LVEF <50%	25 (4.9)	0	1 (3.0)	24 (6.1)
Clinically significant decrease in LVEF or occurrence of CHF^d	10 (2.0)	2 (2.5)	2 (6.1)	6 (1.5)
Patient request	132 (25.9)	24 (29.6)	11 (33.3)	97 (24.6)
Other	98 (19.3)	16 (19.8)	6 (18.2)	76 (19.2)
Unknown	1 (0.2)	0	0	1 (0.3)

CHF=congestive heart failure; LVEF=left ventricular ejection fraction; MS=multiple sclerosis; PRMS=progressive relapsing multiple sclerosis; RENEW=Registry to Evaluate Novantrone Effects in Worsening Multiple Sclerosis; RRMS=relapsing-remitting multiple sclerosis; SPMS=secondary progressive multiple sclerosis.
^aPatients with validated data who have received at least one dose of Mitoxantrone.
^bEight additional patients died following discontinuation; the reasons for discontinuation of Mitoxantrone treatment were: physician discretion (n = 4); patient request (n = 2); LVEF <50% (n = 1); and clinically significant reduction in LVEF/CHF (n = 1).
^cIncludes patients who have reached a cumulative dose of at least 132 mg/m².
^dClinical significance determined by the study site investigator.

ISSN: 1471-2377