. 2021 Aug 11;269(3):1316–1334. doi: 10.1007/s00415-021-10744-x

Table 3.

Clinical trials assessing treatment with ofatumumab in patients with MS

References	Number of patients	Trial design	Clinical findings	MRI findings	Adverse effects
Sorensen et al. [49]	38 RRMS	Phase II, double-blind, randomized, Pbo-controlled study (48 weeks)	Lower proportion of patients with relapse(s) with OFT vs Pbo (19% vs 25%)	↓ new/expanding T2 lesions at week 24 (p < 0.001) ↓ new/total number of Gd+ lesions at week 24 (p < 0.001)	Mostly mild-to-moderate severity AEs 2 patients discontinued for grade-2 (pruritic rash, bronchospasm, cough) and grade-3 (pharyngeal edema, erythema, pruritus) AEs
Bar-Or et al. [50]	232 RRMS	Phase II, double-blind, randomized, Pbo-controlled study (MIRROR) (48 weeks)	Stable EDSS in 79% of patients at week 12 and 24	↓ 65% new Gd+ lesions at week 12 (p < 0.001)	↑ IARs in OFT (52%) vs Pbo (15%) Equivalent infections with OFT and Pbo
Hauser et al. [3]	946 (ASCLEPIOS I) and 936 (ASCLEPIOS II) RRMS	Phase III, double-blind, double-dummy, active-controlled studies (ASCLEPIOS I and ASCLEPIOS II) (30 months)	↓ ARR (ASCLEPIOS I 0.11 OFT vs 0.22 TER, p < 0.001; ASCLEPIOS II 0.10 OFT vs 0.25 TER, p < 0.001) ↓ proportion of patients with 3- and 6-month CDP (10.9% and 8.1% OFT vs 15.0% and 12.0% TER)	↓ Gd+ lesions with OFT vs TER (97.5% ASCLEPIOS I, 93.8% ASCLEPIOS II) ↓ new/enlarging T2 lesions (82% ASCLEPIOS I, 84.5% ASCLEPIOS II) No differences in the annualized rate of brain atrophy OFT vs TER (− 0.28% vs − 0.35% in ASCLEPIOS I; − 0.29% vs − 0.35% ASCLEPIOS II)	Equivalent IARs with OFT (20.2%) vs TER (15%) Equivalent infections with OFT (51.6%) vs TER (52.7%) Equivalent % of neoplasm with OFT (0.5%) vs TER (0.4%)

References

Number of patients

Trial design

Clinical findings

MRI findings

Adverse effects

Sorensen et al. [49]

38 RRMS

Phase II, double-blind, randomized, Pbo-controlled study (48 weeks)

Lower proportion of patients with relapse(s) with OFT vs Pbo (19% vs 25%)

↓ new/expanding T2 lesions at week 24 (p < 0.001)

↓ new/total number of Gd+ lesions at week 24 (p < 0.001)

Mostly mild-to-moderate severity AEs

2 patients discontinued for grade-2 (pruritic rash, bronchospasm, cough) and grade-3 (pharyngeal edema, erythema, pruritus) AEs

Bar-Or et al. [50]

232 RRMS

Phase II, double-blind, randomized, Pbo-controlled study (MIRROR) (48 weeks)

Stable EDSS in 79% of patients at week 12 and 24

↓ 65% new Gd+ lesions at week 12 (p < 0.001)

↑ IARs in OFT (52%) vs Pbo (15%)

Equivalent infections with OFT and Pbo

Hauser et al. [3]

946 (ASCLEPIOS I) and 936 (ASCLEPIOS II) RRMS

Phase III, double-blind, double-dummy, active-controlled studies (ASCLEPIOS I and ASCLEPIOS II) (30 months)

↓ ARR (ASCLEPIOS I 0.11 OFT vs 0.22 TER, p < 0.001; ASCLEPIOS II 0.10 OFT vs 0.25 TER, p < 0.001)

↓ proportion of patients with 3- and 6-month CDP (10.9% and 8.1% OFT vs 15.0% and 12.0% TER)

↓ Gd+ lesions with OFT vs TER (97.5% ASCLEPIOS I, 93.8% ASCLEPIOS II)

↓ new/enlarging T2 lesions (82% ASCLEPIOS I, 84.5% ASCLEPIOS II)

No differences in the annualized rate of brain atrophy OFT vs TER (− 0.28% vs − 0.35% in ASCLEPIOS I; − 0.29% vs − 0.35% ASCLEPIOS II)

Equivalent IARs with OFT (20.2%) vs TER (15%)

Equivalent infections with OFT (51.6%) vs TER (52.7%)

Equivalent % of neoplasm with OFT (0.5%) vs TER (0.4%)

AE adverse events, ARR annualized relapse activity, CDP confirmed disability progression, EDSS expanded Disability Status Scale, Gd+ gadolinium-enhancing, IARs infusion-associated reactions, OFT ofatumumab, Pbo placebo, RRMS relapsing–remitting multiple sclerosis, TER teriflunomide