Phase 3
Completed N=927
Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis
Source: ClinicalTrials.gov NCT02792218 ↗Enrolled (actual)
927
Serious AEs
9.7%
Results posted
Oct 2020
Primary outcomePrimary: Annualized Relapse Rate (ARR) — 0.11; 0.22 number of relapses in a year — p=<0.001
◆ Published Evidence
Highly cited
694citations · ~116 / year
Ofatumumab versus Teriflunomide in Multiple Sclerosis.
Summary
To compare the efficacy and safety of ofatumumab administered subcutaneously (sc) every 4 weeks versus teriflunomide administered orally once daily in patients with relapsing multiple sclerosis
Linked Publications (4)
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Ofatumumab versus Teriflunomide in Multiple Sclerosis.
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Efficacy and safety of ofatumumab in recently diagnosed, treatment-naive patients with multiple sclerosis: Results from ASCLEPIOS I and II.
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Efficacy of Ofatumumab and Teriflunomide in Patients With Relapsing MS From Racial/Ethnic Minority Groups: ASCLEPIOS I/II Subgroup Analyses.
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Cost-consequence analysis of ofatumumab for the treatment of relapsing-remitting multiple sclerosis in Canada.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Annualized Relapse Rate (ARR) |
0.11; 0.22 | <0.001 sig |
| SECONDARY 3-month Confirmed Disability Worsening (3mCDW) Based on EDSS - Pooled Data |
9.4; 13.5; 10.9; 15.0 | 0.003 sig |
| SECONDARY 3-month Confirmed Disability Worsening (3mCDW) Based on EDSS - Study COMB157G2301 |
9.4; 13.9; 11.3; 15.4 | 0.029 sig |
| SECONDARY 6-month Confirmed Disability Worsening (6mCDW) Based on EDSS - Pooled Data |
7.8; 10.7; 8.1; 12.0 | 0.012 sig |
| SECONDARY 6-month Confirmed Disability Worsening (6mCDW) Based on EDSS - Study COMB157G2301 |
7.5; 11.5; 8.2; 13.0 | 0.022 sig |
| SECONDARY 6-month Confirmed Disability Improvement (6mCDI ) Based on EDSS - Pooled Data |
10.1; 7.6; 11.0; 8.2 | 0.092 |
| SECONDARY 6-month Confirmed Disability Improvement (6mCDI ) Based on EDSS - Study COMB157G2301 |
9.1; 7.1; 9.7; 8.2 | 0.516 |
| SECONDARY Number of Gd-enhancing T1 Lesions Per MRI Scan |
0.0115; 0.4555 | <.001 sig |
| SECONDARY Number of New or Enlarging T2 Lesions on MRI Per Year (Annualized Lesion Rate) |
1.13; 4.30; 0.72; 3.21; 0.72; 4.00 | <.001 sig |
| SECONDARY Neurofilament Light Chain (NfL) Concentration in Serum |
8.80; 9.41; 7.02; 9.63; 6.90; 8.99 | 0.011 sig |
| SECONDARY Annualized Rate of Brain Volume Loss Based on Assessments of Percent Brain Volume Change From Baseline |
-0.28; -0.35 | 0.118 |
| SECONDARY Percentage of Participants With Confirmed Relapse |
18.82; 32.73 | — |
| SECONDARY Annualized Relapse Rate (ARR) >8 Weeks After Onset of Treatment |
0.096; 0.242 | — |
| SECONDARY 3-month Confirmed Disability Worsening (3mCDW) Based on EDSS > 8 Weeks After Onset of Treatment - Pooled Data |
9.4; 13.5; 10.9; 15.0 | 0.002 sig |
| SECONDARY 6-month Confirmed Disability Worsening (6mCDW) Based on EDSS > 8 Weeks After Onset of Treatment - Pooled Data |
7.8; 10.7; 8.1; 12.0 | 0.008 sig |
| SECONDARY 6-month Confirmed Cognitive Decline on Symbol Digit Modalities Test (SDMT) - Pooled Data |
14.3; 13.7; 15.4; 12.4 | — |
| SECONDARY 6-month Confirmed Disability Worsening (6mCDW) or 6-month Confirmed Cognitive Decline (6mCCD) - Pooled Data |
20.5; 21.7; 21.4; 22.6 | — |
| SECONDARY Change in Cognitive Performance Measured by the Symbol Digit Modalities Test (SDMT) - Pooled Data |
1.02; 0.64; 1.82; 1.70; 2.84; 2.05 | — |
| SECONDARY 6-month Confirmed Worsening of at Least 20% in the Timed 25-Foot Walk (T25FW) - Pooled Data |
11.0; 10.4; 11.4; 10.6 | — |
| SECONDARY 6-month Confirmed Worsening of at Least 20% in the 9-Hole Peg Test (9HPT) - Pooled Data |
2.9; 3.3; 2.9; 3.3 | — |
| SECONDARY 6-month Confirmed Disability Improvement (6mCDI) Sustained Until End of Study (EOS) as Measured by EDSS - Pooled Data |
5.4; 4.6; 5.8; 4.6 | — |
| SECONDARY Number of New or Enlarging T2 Lesions on MRI Per Year From Month 12 Until End of Study (EOS) |
0.05; 3.73 | — |
| SECONDARY Percent Change in T2 Lesion Volume Relative to Baseline |
-1.4; 9.7; -2.6; 13.5 | — |
| SECONDARY No Evidence of Disease Activity (NEDA-4) |
23.4; 14.8; 14.4; 3.2 | — |
| SECONDARY Multiple Sclerosis Impact Scale (MSIS-29) Physical Impact Score Change From Baseline |
-2.75; -0.44; -2.43; 0.17; -2.37; 0.67 | — |
| SECONDARY Multiple Sclerosis Impact Scale (MSIS-29) Psychological Impact Score Change From Baseline |
-5.20; -3.07; -5.22; -2.57; -5.72; -3.94 | — |
| SECONDARY Annualized Relapse Rates (ARR) by NfL High-low Subgroups - Pooled Data |
0.08; 0.21; 0.12; 0.23 | — |
| SECONDARY Number of New or Enlarging T2 Lesions Per Year by NfL High-low Subgroups - Pooled Data |
0.95; 5.28; 0.39; 3.02 | — |
| SECONDARY Annual Rate of Percent Change in Brain Volume Loss by NfL High-low Subgroups - Pooled Data |
-0.32; -0.43; -0.24; -0.29 | — |
| SECONDARY Pharmacokinetic (PK) Concentrations of Ofatumumab |
0.00267; 1.25746; 0.22645; 0.36991; 0.51280; 1.05314 | — |
Eligibility Criteria
Inclusion Criteria
- 18 to 55 years of age
- Diagnosis of multiple sclerosis (MS)
- Relapsing MS: relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS)
- At least 1 relapse during the previous 1 year or 2 relapses during the previous 2 years or a positive gadolinium-enhancing MRI scan in previous year
- Expanded disability status scale (EDSS) score of 0 to 5.5
Exclusion Criteria
- Primary progressive MS
- Disease duration of more than 10 years in patients with an EDSS score of 2 or less
- Patients with an active chronic disease of the immune system other than MS
- Patients at risk of developing or having reactivation of hepatitis
- Patients with active systemic infections or with neurological findings consistent with PML
Data sourced from ClinicalTrials.gov (NCT02792218) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.