Relating relapse and T2 lesion changes to disability progression in multiple sclerosis: a systematic literature review and regression analysis

Fahrbach, Kyle; Huelin, Rachel; Martin, Amber L; Kim, Edward; Dastani, Homa B; Rao, Stephen; Malhotra, Manoj

doi:10.1186/1471-2377-13-180

Table 2 Study summaries in trials reporting MRI changes and disability progression

From: Relating relapse and T2 lesion changes to disability progression in multiple sclerosis: a systematic literature review and regression analysis

Trial	Follow-up (months)	Comparison	Patients Analyzed	Change in T2 Lesion Volume Experimental Arm	Change in T2 Lesion Volume Control Arm	Final T2 Lesion Volume Ratio	New and/or Enlarged T2 Lesion Experimental Arm	New and or Enlarged T2 Lesion Control Arm	T2 Lesion Count Ratio	EDSS Progression Experimental Arm	EDSS Progression Control Arm	Disability Risk Ratio
Kappos L, et al. [29]	24	IFNB-1b 250 μg vs. Placebo	468	-10.60	-5.00	0.941	3.70	8.50	0.435	12.00	20.00	0.600
Comi G, et al. [17]	24	IFNB-1a 22 μg vs. Placebo	300	-13.00	8.80	0.800	2.00	3.00	0.667	15.00	20.00	0.750
Hartung HP, et al. [24]	36	Mitoxantrone 12 mg vs. Placebo	124				0.29	1.94	0.149	8.00	22.00	0.364
Rudick RA, et al. [38]	24	IFNB-1a plus Natalizumab vs. IFNB 1a	1171				0.90	5.40	0.167	23.00	29.00	0.793
Havrdova E, et al. [25]	24	IFNB-1a plus Azathioprinethioprine vs. IFNB-1a	88	24.60	30.30	0.956				20.70	16.80	1.232
Havrdova E, et al. [25]	24	IFNB-1a plus azathioprine plus prednisone vs. IFNB-1a	93	14.50	30.30	0.879				17.50	16.80	1.042
Mikol DD, et al. [32]	22	Glatiramer acetate vs. IFNB-1a	585				0.82	0.67	1.224	8.70	11.70	0.744
Ravnborg M, et al. [37]	36	IFNB-1a plus Methylprednisolone vs. IFNB-1a	220	-1.06	1.21	0.978	5.20	8.00	0.650	25.00	28.50	0.877
Sorensen PS, et al. [39]	22	IFNB-1a plus Methylprednisolone vs. IFNB-1a	110				2.70	3.50	0.771	16.00	25.00	0.640
O’Connor P, et al. [34]	42	Glatiramer acetate vs. IFNB-1b 250 μg	913	17.00	10.00	1.064	4.60	3.30	1.394	20.50	22.30	0.919
O’Connor P, et al. [34]	42	Glatiramer acetate vs. IFNB-1b 500 μg	971	17.00	12.00	1.045	4.60	3.30	1.394	20.50	22.30	0.919
Freedman MS, et al. [21]	36	Placebo/IFNB-1a 44 μg vs. Placebo/IFNB-1a 22 μg	53	-3.40	1.10	0.955	2.00	1.70	1.176	46.00	40.00	1.150
Freedman MS, et al. [21]	36	Placebo/IFNB-1a 44 μg vs. IFNB-1a 22 μg	83	5.40	1.10	1.043	1.70	1.70	1.000	39.00	40.00	0.975
Freedman MS, et al. [21]	36	Placebo/IFNB-1a 44 μg vs. IFNB-1a 22 μg	85	1.80	1.10	1.007	1.30	1.70	0.765	35.00	40.00	0.875
Coles AJ, et al. [16]	36	Alemtuzumab vs. IFNB-1a	227	-16.40	-13.30	0.964				9.00	26.20	0.344
Kappos L, et al. [30]	24	Fingolimod 0.5 mg vs. Placebo	537	-1.69	8.61	0.905	2.50	9.80	0.255	17.70	24.10	0.734
Kappos L, et al. [30]	24	Fingolimod 1.25 mg vs. Placebo	512	-3.10	8.61	0.892	2.50	9.80	0.255	16.60	24.10	0.689
Polman CH, et al. [36]	24	Natalizumab vs. Placebo	942				1.90	11.00	0.173	17.00	29.00	0.586
Clanet M et al. [14]	36	IFNB-1a 60 μg vs. IFNB-1a 30 μg	386	-0.20	-1.29	1.011	8.00	9.00	0.889	37.00	37.00	1.000
Ebers GC, et al. [9]		IFNB-1a 22 μg vs. Placebo	279	-1.20	10.90	0.891	9.00	15.50	0.581	30.00	38.00	0.789
Ebers GC, et al. [9]		IFNB-1a 44 μg vs. Placebo	281	-3.80	10.90	0.867	5.50	15.50	0.355	26.50	38.00	0.697
Baumhackl U, et al. [13]	24	Hydrolytic enzymes vs. Placebo	291	-1.00	-1.00	1.000				28.00	26.00	1.077
Millefiorini E, et al. [33]	24	Mitoxantrone vs. Placebo	42				3.50	7.30	0.479	7.00	37.00	0.189
Giovannoni G, et al. [22]	22	Cladribine 5.25 mg/kg bw vs. Placebo	674				0.33	1.43	0.231	15.10	20.60	0.733
Giovannoni G, et al. [22]	22	Cladribine 3.5 mg/kg bw vs. Placebo	651				0.38	1.43	0.266	14.30	20.60	0.694
Jacobs LD, et al. [26]	24	IFNB-1a vs. Placebo	164	-13.20	-6.50	0.928				21.10	33.30	0.633
Ebers GC, et al. [8]	36	IFNB-1b 1.6 MIU vs. Placebo	164	0.20	15.00	0.871	1.80	4.90	0.367	28.00	28.00	1.000
Ebers GC, et al. [8]	36	IFNB-1b 8 MIU vs. Placebo	167	-9.30	15.00	0.789	2.00	4.90	0.408	20.00	28.00	0.714
Panitch H, et al. [35]	36	IFNB-1b 160 μg vs. Placebo	81	0.80	10.90	0.909				39.00	34.00	1.147
Panitch H, et al. [35]	36	IFNB-1b 250 μg vs. Placebo	81	0.40	10.90	0.905				32.00	34.00	0.941
Edan G, et al. [41]	36	Mitoxantrone 12 mg/m² vs. IFNβ-1b 250 μg	109				2.15	3.50	0.614	9.10	25.90	0.351
Freedman MS, et al. [42]	24	MBP8298 vs. Placebo in DR2+ and/or DR4+ haplotypes	513	0.90	6.20	0.95	3.90	3.30	1.182	30.70	27.80	1.104
Freedman MS, et al. [42]	24	MBP8298 vs. Placebo in DR2- and/or DR4- haplotypes	99	16.10	0.70	1.15	3.20	3.30	0.970	28.30	35.80	0.791
Comi G, et al. [45]	24	Laquinimod 0.6 mg vs. Placebo	1,106				5.03	7.14	0.704	11.10	15.70	0.707
Cohen JA, et al. [43]	24	Alemtuzumab 12 mg vs. IFNβ-1a 44 μg	563	-9.30	-6.50	0.97				8.00	11.12	0.719
Coles AJ, et al. [44]	24	Alemtuzumab 12 mg vs. IFNβ-1a 44 μg	667	-1.27	-1.23	1.00				12.71	21.13	0.602
Gold R, et al. [47]	24	Dimethyl fumarate 240 mg BID vs. Placebo	818				2.60	17.00	0.153	16.00	27.00	0.593
Gold R, et al. [47]	24	Dimethyl fumarate 240 mg TID vs. Placebo	824				4.40	17.00	0.259	18.00	27.00	0.667
Fox RJ, et al. [46]	24	Dimethyl fumarate 240 mg BID vs. Placebo	480				5.10	17.40	0.293	13.00	17.00	0.765
Fox RJ, et al. [46]	24	Dimethyl fumarate 240 mg TID vs. Placebo	466				4.70	17.40	0.270	13.00	17.00	0.765
Fox RJ, et al. [46]	24	Glatiramer acetate vs. Placebo	471				8.00	17.40	0.460	16.00	17.00	0.941

BID, twice daily; EDSS, Expanded Disability Status Scale; IFNB, Interferon-beta; μg, microgram; mg, milligram; mg/m2, milligrams per square meter of body surface; mg/kg bw, milligram per kilogram of body weight; MIU, million international units; TID, three times daily.

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