Trial Outcomes & Findings for A Multicenter Study to Assess Response to Influenza Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab (NCT NCT04667117)

Last Updated: 2024-10-09

Results Overview

A seroprotection responder was a participant achieving seroprotection as defined by a post-vaccination hemagglutination inhibition (HI) titer ≥ 40 at Week 4. Seroprotection against ten influenza strains was analyzed. The analysis was performed taking into consideration observed data.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

63 participants

Primary outcome timeframe

Week 4

Results posted on

2024-10-09

Participant Flow

This study was conducted in 3 sites in the United States.

Participants underwent a screening period of up to 1 week. After screening there was a 4-week investigational period and an optional 6-month open-label extension period.

Participant milestones

Participant milestones
Measure	Cohort 1 Patients with relapsing multiple sclerosis (MS) receiving a 2020-2021, 2021-2022, or 2022-2023 inactivated influenza vaccine two weeks prior to ofatumumab start	Cohort 2 Patients with relapsing MS receiving a 2020-2021, 2021-2022, 2022-2023 inactivated influenza vaccine at least 4 weeks after ofatumumab start	Cohort 3 Patients with relapsing MS currently on iDMT receiving a 2020-2021, 2021-2022, or 2022-2023 inactivated influenza vaccine
Investigational Period STARTED	22	22	19
Investigational Period COMPLETED	22	21	18
Investigational Period NOT COMPLETED	0	1	1
Extension Period STARTED	22	11	0
Extension Period COMPLETED	21	11	0
Extension Period NOT COMPLETED	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1 Patients with relapsing multiple sclerosis (MS) receiving a 2020-2021, 2021-2022, or 2022-2023 inactivated influenza vaccine two weeks prior to ofatumumab start	Cohort 2 Patients with relapsing MS receiving a 2020-2021, 2021-2022, 2022-2023 inactivated influenza vaccine at least 4 weeks after ofatumumab start	Cohort 3 Patients with relapsing MS currently on iDMT receiving a 2020-2021, 2021-2022, or 2022-2023 inactivated influenza vaccine
Investigational Period Lost to Follow-up	0	0	1
Investigational Period Protocol Deviation	0	1	0
Extension Period Lost to Follow-up	1	0	0

Baseline Characteristics

A Multicenter Study to Assess Response to Influenza Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 n=22 Participants Patients with relapsing multiple sclerosis (MS) receiving a 2020-2021, 2021-2022, or 2022-2023 inactivated influenza vaccine two weeks prior to ofatumumab start	Cohort 2 n=22 Participants Patients with relapsing MS receiving a 2020-2021, 2021-2022, 2022-2023 inactivated influenza vaccine at least 4 weeks after ofatumumab start	Cohort 3 n=19 Participants Patients with relapsing MS currently on iDMT receiving a 2020-2021, 2021-2022, or 2022-2023 inactivated influenza vaccine	Total n=63 Participants Total of all reporting groups
Age, Continuous	41.4 years STANDARD_DEVIATION 8.88 • n=5 Participants	38.9 years STANDARD_DEVIATION 9.03 • n=7 Participants	43.3 years STANDARD_DEVIATION 7.12 • n=5 Participants	41.1 years STANDARD_DEVIATION 8.50 • n=4 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	15 Participants n=7 Participants	14 Participants n=5 Participants	48 Participants n=4 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	7 Participants n=7 Participants	5 Participants n=5 Participants	15 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	9 Participants n=4 Participants
Race/Ethnicity, Customized White	21 Participants n=5 Participants	18 Participants n=7 Participants	15 Participants n=5 Participants	54 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 4

Population: Participants in the Safety Set with an available value for the outcome measure. Safety Set included all participants who had received inactivated influenza vaccine and at last 1 dose of study drug. For each influenza strain, the number of participants analyzed corresponds to the participants with both pre-vaccination and post-vaccination HI titers for the corresponding strain.

Outcome measures

Outcome measures
Measure	Cohort 1 n=18 Participants Patients with relapsing multiple sclerosis (MS) receiving a 2020-2021, 2021-2022, or 2022-2023 inactivated influenza vaccine two weeks prior to ofatumumab start	Cohort 2 n=22 Participants Patients with relapsing MS receiving a 2020-2021, 2021-2022, 2022-2023 inactivated influenza vaccine at least 4 weeks after ofatumumab start	Cohort 3 n=17 Participants Patients with relapsing MS currently on iDMT receiving a 2020-2021, 2021-2022, or 2022-2023 inactivated influenza vaccine
Percentage of Participants Achieving Seroprotection at Week 4 (Observed Case) Influenza A Brisbane	100.00 percentage of participants Interval 47.82 to 100.0	100.00 percentage of participants Interval 15.81 to 100.0	100.00 percentage of participants Interval 2.5 to 100.0
Percentage of Participants Achieving Seroprotection at Week 4 (Observed Case) Influenza A Cambodia	100.00 percentage of participants Interval 75.29 to 100.0	80.00 percentage of participants Interval 28.36 to 99.49	85.71 percentage of participants Interval 42.13 to 99.64
Percentage of Participants Achieving Seroprotection at Week 4 (Observed Case) Influenza A Kansas	100.00 percentage of participants Interval 47.82 to 100.0	100.00 percentage of participants Interval 15.81 to 100.0	100.00 percentage of participants Interval 2.5 to 100.0
Percentage of Participants Achieving Seroprotection at Week 4 (Observed Case) Influenza A Michigan	100.00 percentage of participants Interval 47.82 to 100.0	100.00 percentage of participants Interval 15.81 to 100.0	100.00 percentage of participants Interval 2.5 to 100.0
Percentage of Participants Achieving Seroprotection at Week 4 (Observed Case) Influenza A Singapore	100.00 percentage of participants Interval 47.82 to 100.0	100.00 percentage of participants Interval 15.81 to 100.0	100.00 percentage of participants Interval 2.5 to 100.0
Percentage of Participants Achieving Seroprotection at Week 4 (Observed Case) Influenza A Victoria	100.00 percentage of participants Interval 75.29 to 100.0	100.00 percentage of participants Interval 47.82 to 100.0	100.00 percentage of participants Interval 59.04 to 100.0
Percentage of Participants Achieving Seroprotection at Week 4 (Observed Case) Influenza A Wisconsin	61.54 percentage of participants Interval 31.58 to 86.14	40.00 percentage of participants Interval 19.12 to 63.95	68.75 percentage of participants Interval 41.34 to 88.98
Percentage of Participants Achieving Seroprotection at Week 4 (Observed Case) Influenza B Colorado	60.00 percentage of participants Interval 14.66 to 94.73	50.00 percentage of participants Interval 1.26 to 98.74	100.00 percentage of participants Interval 2.5 to 100.0
Percentage of Participants Achieving Seroprotection at Week 4 (Observed Case) Influenza B Phuket	77.78 percentage of participants Interval 52.36 to 93.59	68.18 percentage of participants Interval 45.13 to 86.14	76.47 percentage of participants Interval 50.1 to 93.19
Percentage of Participants Achieving Seroprotection at Week 4 (Observed Case) Influenza B Washington	76.92 percentage of participants Interval 46.19 to 94.96	20.00 percentage of participants Interval 0.51 to 71.64	71.43 percentage of participants Interval 29.04 to 96.33

PRIMARY outcome

Timeframe: Week 4

Population: Safety Set including all participants who had received inactivated influenza vaccine and at last 1 dose of study drug. For each influenza strain, the number of participants analyzed corresponds to the participants with pre-vaccination HI titers for the corresponding strain.

A seroprotection responder was a participant achieving seroprotection as defined by a post-vaccination hemagglutination inhibition (HI) titer ≥ 40 at Week 4. Seroprotection against ten influenza strains was analyzed. Non-responder imputation (NRI) for missing data was applied.

Outcome measures

Outcome measures
Measure	Cohort 1 n=22 Participants Patients with relapsing multiple sclerosis (MS) receiving a 2020-2021, 2021-2022, or 2022-2023 inactivated influenza vaccine two weeks prior to ofatumumab start	Cohort 2 n=22 Participants Patients with relapsing MS receiving a 2020-2021, 2021-2022, 2022-2023 inactivated influenza vaccine at least 4 weeks after ofatumumab start	Cohort 3 n=19 Participants Patients with relapsing MS currently on iDMT receiving a 2020-2021, 2021-2022, or 2022-2023 inactivated influenza vaccine
Percentage of Participants Achieving Seroprotection at Week 4 (Non-responder Imputation) Influenza A Brisbane	55.56 percentage of participants Interval 21.2 to 86.3	66.67 percentage of participants Interval 9.43 to 99.16	100.00 percentage of participants Interval 2.5 to 100.0
Percentage of Participants Achieving Seroprotection at Week 4 (Non-responder Imputation) Influenza A Cambodia	86.67 percentage of participants Interval 59.54 to 98.34	80.00 percentage of participants Interval 28.36 to 99.49	66.67 percentage of participants Interval 29.93 to 92.51
Percentage of Participants Achieving Seroprotection at Week 4 (Non-responder Imputation) Influenza A Kansas	55.56 percentage of participants Interval 21.2 to 86.3	66.67 percentage of participants Interval 9.43 to 99.16	100.00 percentage of participants Interval 2.5 to 100.0
Percentage of Participants Achieving Seroprotection at Week 4 (Non-responder Imputation) Influenza A Michigan	55.56 percentage of participants Interval 21.2 to 86.3	66.67 percentage of participants Interval 9.43 to 99.16	100.00 percentage of participants Interval 2.5 to 100.0
Percentage of Participants Achieving Seroprotection at Week 4 (Non-responder Imputation) Influenza A Singapore	55.56 percentage of participants Interval 21.2 to 86.3	66.67 percentage of participants Interval 9.43 to 99.16	100.00 percentage of participants Interval 2.5 to 100.0
Percentage of Participants Achieving Seroprotection at Week 4 (Non-responder Imputation) Influenza A Victoria	86.67 percentage of participants Interval 59.54 to 98.34	100.00 percentage of participants Interval 47.82 to 100.0	77.78 percentage of participants Interval 39.99 to 97.19
Percentage of Participants Achieving Seroprotection at Week 4 (Non-responder Imputation) Influenza A Wisconsin	53.33 percentage of participants Interval 26.59 to 78.73	40.00 percentage of participants Interval 19.12 to 63.95	61.11 percentage of participants Interval 35.75 to 82.7
Percentage of Participants Achieving Seroprotection at Week 4 (Non-responder Imputation) Influenza B Colorado	33.33 percentage of participants Interval 7.49 to 70.07	33.33 percentage of participants Interval 0.84 to 90.57	100.00 percentage of participants Interval 2.5 to 100.0
Percentage of Participants Achieving Seroprotection at Week 4 (Non-responder Imputation) Influenza B Phuket	63.64 percentage of participants Interval 40.66 to 82.8	68.18 percentage of participants Interval 45.13 to 86.14	68.42 percentage of participants Interval 43.45 to 87.42
Percentage of Participants Achieving Seroprotection at Week 4 (Non-responder Imputation) Influenza B Washington	66.67 percentage of participants Interval 38.38 to 88.18	20.00 percentage of participants Interval 0.51 to 71.64	55.56 percentage of participants Interval 21.2 to 86.3

SECONDARY outcome

Timeframe: Baseline (pre-vaccination), Week 4

Seroconversion was defined as: • a ≥ 4-fold increase in HI titers after vaccination (in participants with pre-vaccination HI titers ≥ 10) OR • post-vaccination HI titers ≥ 40 (in participants with pre-vaccination HI titers \< 10) Seroconversion against ten influenza strains was analyzed. The analysis was performed taking into consideration observed data.

Outcome measures

Outcome measures
Measure	Cohort 1 n=18 Participants Patients with relapsing multiple sclerosis (MS) receiving a 2020-2021, 2021-2022, or 2022-2023 inactivated influenza vaccine two weeks prior to ofatumumab start	Cohort 2 n=22 Participants Patients with relapsing MS receiving a 2020-2021, 2021-2022, 2022-2023 inactivated influenza vaccine at least 4 weeks after ofatumumab start	Cohort 3 n=17 Participants Patients with relapsing MS currently on iDMT receiving a 2020-2021, 2021-2022, or 2022-2023 inactivated influenza vaccine
Percentage of Participants Achieving Seroconversion at Week 4 (Observed Case) Influenza A Brisbane	80.00 percentage of participants Interval 28.36 to 99.49	0.00 percentage of participants Interval 0.0 to 84.19	0.00 percentage of participants Interval 0.0 to 97.5
Percentage of Participants Achieving Seroconversion at Week 4 (Observed Case) Influenza A Cambodia	84.62 percentage of participants Interval 54.55 to 98.08	20.00 percentage of participants Interval 0.51 to 71.64	42.86 percentage of participants Interval 9.9 to 81.59
Percentage of Participants Achieving Seroconversion at Week 4 (Observed Case) Influenza A Kansas	40.00 percentage of participants Interval 5.27 to 85.34	0.00 percentage of participants Interval 0.0 to 84.19	0.00 percentage of participants Interval 0.0 to 97.5
Percentage of Participants Achieving Seroconversion at Week 4 (Observed Case) Influenza A Michigan	60.00 percentage of participants Interval 14.66 to 94.73	0.00 percentage of participants Interval 0.0 to 84.19	100.00 percentage of participants Interval 2.5 to 100.0
Percentage of Participants Achieving Seroconversion at Week 4 (Observed Case) Influenza A Singapore	40.00 percentage of participants Interval 5.27 to 85.34	0.00 percentage of participants Interval 0.0 to 84.19	0.00 percentage of participants Interval 0.0 to 97.5
Percentage of Participants Achieving Seroconversion at Week 4 (Observed Case) Influenza A Victoria	92.31 percentage of participants Interval 63.97 to 99.81	20.00 percentage of participants Interval 0.51 to 71.64	42.86 percentage of participants Interval 9.9 to 81.59
Percentage of Participants Achieving Seroconversion at Week 4 (Observed Case) Influenza A Wisconsin	46.15 percentage of participants Interval 19.22 to 74.87	10.00 percentage of participants Interval 1.23 to 31.7	37.50 percentage of participants Interval 15.2 to 64.57
Percentage of Participants Achieving Seroconversion at Week 4 (Observed Case) Influenza B Colorado	60.00 percentage of participants Interval 14.66 to 94.73	0.00 percentage of participants Interval 0.0 to 84.19	100.00 percentage of participants Interval 2.5 to 100.0
Percentage of Participants Achieving Seroconversion at Week 4 (Observed Case) Influenza B Phuket	50.00 percentage of participants Interval 26.02 to 73.98	18.18 percentage of participants Interval 5.19 to 40.28	41.18 percentage of participants Interval 18.44 to 67.08
Percentage of Participants Achieving Seroconversion at Week 4 (Observed Case) Influenza B Washington	38.46 percentage of participants Interval 13.86 to 68.42	0.00 percentage of participants Interval 0.0 to 52.18	42.86 percentage of participants Interval 9.9 to 81.59

SECONDARY outcome

Timeframe: Baseline (pre-vaccination), Week 4

Seroconversion was defined as: • a ≥ 4-fold increase in HI titers after vaccination (in participants with pre-vaccination HI titers ≥ 10) OR • post-vaccination HI titers ≥ 40 (in participants with pre-vaccination HI titers \< 10) Seroconversion against ten influenza strains was analyzed. Non-responder imputation (NRI) for missing data was applied.

Outcome measures

Outcome measures
Measure	Cohort 1 n=22 Participants Patients with relapsing multiple sclerosis (MS) receiving a 2020-2021, 2021-2022, or 2022-2023 inactivated influenza vaccine two weeks prior to ofatumumab start	Cohort 2 n=22 Participants Patients with relapsing MS receiving a 2020-2021, 2021-2022, 2022-2023 inactivated influenza vaccine at least 4 weeks after ofatumumab start	Cohort 3 n=19 Participants Patients with relapsing MS currently on iDMT receiving a 2020-2021, 2021-2022, or 2022-2023 inactivated influenza vaccine
Percentage of Participants Achieving Seroconversion at Week 4 (Non-responder Imputation) Influenza A Brisbane	44.44 percentage of participants Interval 13.7 to 78.8	0.00 percentage of participants Interval 0.0 to 70.76	0.00 percentage of participants Interval 0.0 to 97.5
Percentage of Participants Achieving Seroconversion at Week 4 (Non-responder Imputation) Influenza A Cambodia	73.33 percentage of participants Interval 44.9 to 92.21	20.00 percentage of participants Interval 0.51 to 71.64	33.33 percentage of participants Interval 7.49 to 70.07
Percentage of Participants Achieving Seroconversion at Week 4 (Non-responder Imputation) Influenza A Kansas	22.22 percentage of participants Interval 2.81 to 60.01	0.00 percentage of participants Interval 0.0 to 70.76	0.00 percentage of participants Interval 0.0 to 97.5
Percentage of Participants Achieving Seroconversion at Week 4 (Non-responder Imputation) Influenza A Michigan	33.33 percentage of participants Interval 7.49 to 70.07	0.00 percentage of participants Interval 0.0 to 70.76	100.00 percentage of participants Interval 2.5 to 100.0
Percentage of Participants Achieving Seroconversion at Week 4 (Non-responder Imputation) Influenza A Singapore	22.22 percentage of participants Interval 2.81 to 60.01	0.00 percentage of participants Interval 0.0 to 70.76	0.00 percentage of participants Interval 0.0 to 97.5
Percentage of Participants Achieving Seroconversion at Week 4 (Non-responder Imputation) Influenza A Victoria	80.00 percentage of participants Interval 51.91 to 95.67	20.00 percentage of participants Interval 0.51 to 71.64	33.33 percentage of participants Interval 7.49 to 70.07
Percentage of Participants Achieving Seroconversion at Week 4 (Non-responder Imputation) Influenza A Wisconsin	40.00 percentage of participants Interval 16.34 to 67.71	10.00 percentage of participants Interval 1.23 to 31.7	33.33 percentage of participants Interval 13.34 to 59.01
Percentage of Participants Achieving Seroconversion at Week 4 (Non-responder Imputation) Influenza B Colorado	33.33 percentage of participants Interval 7.49 to 70.07	0.00 percentage of participants Interval 0.0 to 70.76	100.00 percentage of participants Interval 2.5 to 100.0
Percentage of Participants Achieving Seroconversion at Week 4 (Non-responder Imputation) Influenza B Phuket	40.91 percentage of participants Interval 20.71 to 63.65	18.18 percentage of participants Interval 5.19 to 40.28	36.84 percentage of participants Interval 16.29 to 61.64
Percentage of Participants Achieving Seroconversion at Week 4 (Non-responder Imputation) Influenza B Washington	33.33 percentage of participants Interval 11.82 to 61.62	0.00 percentage of participants Interval 0.0 to 52.18	33.33 percentage of participants Interval 7.49 to 70.07

SECONDARY outcome

Timeframe: Baseline (pre-vaccination), Week 4

Hemagglutination inhibition (HI) antibody titers were measured in serum samples pre-vaccination (baseline) and post-vaccination (Week 4). The geometric mean of the ratio of post-vaccination to pre-vaccination HI titer was calculated to estimate the average fold change in HI titer after vaccination compared to before vaccination.

Outcome measures

Outcome measures
Measure	Cohort 1 n=18 Participants Patients with relapsing multiple sclerosis (MS) receiving a 2020-2021, 2021-2022, or 2022-2023 inactivated influenza vaccine two weeks prior to ofatumumab start	Cohort 2 n=22 Participants Patients with relapsing MS receiving a 2020-2021, 2021-2022, 2022-2023 inactivated influenza vaccine at least 4 weeks after ofatumumab start	Cohort 3 n=17 Participants Patients with relapsing MS currently on iDMT receiving a 2020-2021, 2021-2022, or 2022-2023 inactivated influenza vaccine
Fold Change From Baseline in Hemagglutination Inhibition Titers Influenza A Brisbane	5.3 Ratio to baseline in HI titer Interval 2.3 to 12.3	1.4 Ratio to baseline in HI titer Interval 0.0 to 115.6	2.0 Ratio to baseline in HI titer
Fold Change From Baseline in Hemagglutination Inhibition Titers Influenza A Cambodia	9.4 Ratio to baseline in HI titer Interval 4.2 to 21.0	1.4 Ratio to baseline in HI titer Interval 0.4 to 5.5	2.9 Ratio to baseline in HI titer Interval 1.1 to 7.7
Fold Change From Baseline in Hemagglutination Inhibition Titers Influenza A Kansas	2.6 Ratio to baseline in HI titer Interval 1.0 to 7.0	1.0 Ratio to baseline in HI titer In instances where SD=0 (because all values were the same), the confidence interval for the geometric mean was not calculated as the limits of the confidence interval are exactly the same as the geometric mean.	2.0 Ratio to baseline in HI titer
Fold Change From Baseline in Hemagglutination Inhibition Titers Influenza A Michigan	5.5 Ratio to baseline in HI titer Interval 1.1 to 26.8	0.9 Ratio to baseline in HI titer Interval 0.1 to 5.4	4.0 Ratio to baseline in HI titer
Fold Change From Baseline in Hemagglutination Inhibition Titers Influenza A Singapore	4.3 Ratio to baseline in HI titer Interval 0.9 to 20.6	1.0 Ratio to baseline in HI titer In instances where SD=0 (because all values were the same), the confidence interval for the geometric mean was not calculated as the limits of the confidence interval are exactly the same as the geometric mean.	2.0 Ratio to baseline in HI titer
Fold Change From Baseline in Hemagglutination Inhibition Titers Influenza A Victoria	8.6 Ratio to baseline in HI titer Interval 4.3 to 17.3	1.3 Ratio to baseline in HI titer Interval 0.5 to 3.5	3.6 Ratio to baseline in HI titer Interval 1.2 to 11.3
Fold Change From Baseline in Hemagglutination Inhibition Titers Influenza A Wisconsin	4.9 Ratio to baseline in HI titer Interval 2.0 to 12.0	1.7 Ratio to baseline in HI titer Interval 1.0 to 3.0	2.6 Ratio to baseline in HI titer Interval 1.2 to 5.4
Fold Change From Baseline in Hemagglutination Inhibition Titers Influenza B Colorado	3.0 Ratio to baseline in HI titer Interval 1.1 to 8.1	1.4 Ratio to baseline in HI titer Interval 0.0 to 115.6	4.0 Ratio to baseline in HI titer
Fold Change From Baseline in Hemagglutination Inhibition Titers Influenza B Phuket	3.8 Ratio to baseline in HI titer Interval 2.5 to 5.7	1.3 Ratio to baseline in HI titer Interval 0.9 to 1.9	2.2 Ratio to baseline in HI titer Interval 1.0 to 4.6
Fold Change From Baseline in Hemagglutination Inhibition Titers Influenza B Washington	3.5 Ratio to baseline in HI titer Interval 1.7 to 7.3	0.9 Ratio to baseline in HI titer Interval 0.6 to 1.3	2.8 Ratio to baseline in HI titer Interval 1.3 to 6.0

SECONDARY outcome

Timeframe: From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)

Population: Safety Set including all participants who had received inactivated influenza vaccine and at last 1 dose of study drug.

Number of participants with adverse events (any AEs regardless of seriousness), AEs leading to study drug discontinuation and serious adverse events (SAEs). On-study AEs are defined as AEs which started or worsened on or after the date of the visit at Week 0.

Outcome measures

Outcome measures
Measure	Cohort 1 n=22 Participants Patients with relapsing multiple sclerosis (MS) receiving a 2020-2021, 2021-2022, or 2022-2023 inactivated influenza vaccine two weeks prior to ofatumumab start	Cohort 2 n=22 Participants Patients with relapsing MS receiving a 2020-2021, 2021-2022, 2022-2023 inactivated influenza vaccine at least 4 weeks after ofatumumab start	Cohort 3 n=19 Participants Patients with relapsing MS currently on iDMT receiving a 2020-2021, 2021-2022, or 2022-2023 inactivated influenza vaccine
Number of Participants With Adverse Events (AEs), AEs Leading to Discontinuation and Serious Adverse Events (SAEs) AEs	16 Participants	6 Participants	2 Participants
Number of Participants With Adverse Events (AEs), AEs Leading to Discontinuation and Serious Adverse Events (SAEs) AEs leading to study drug discontinuation	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events (AEs), AEs Leading to Discontinuation and Serious Adverse Events (SAEs) SAEs	0 Participants	1 Participants	0 Participants

Adverse Events

Cohort 1

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Cohort 2

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Cohort 3

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1 n=22 participants at risk Patients with relapsing multiple sclerosis (MS) receiving a 2020-2021, 2021-2022, or 2022-2023 inactivated influenza vaccine two weeks prior to ofatumumab start	Cohort 2 n=22 participants at risk Patients with relapsing MS receiving a 2020-2021, 2021-2022, 2022-2023 inactivated influenza vaccine at least 4 weeks after ofatumumab start	Cohort 3 n=19 participants at risk Patients with relapsing MS currently on iDMT receiving a 2020-2021, 2021-2022, or 2022-2023 inactivated influenza vaccine
Nervous system disorders Multiple sclerosis pseudo relapse	0.00% 0/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	4.5% 1/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/19 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)

Other adverse events

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. Novartis does not prohibit any investigator from publishing. Any publications from a single site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	Cohort 1 n=22 participants at risk Patients with relapsing multiple sclerosis (MS) receiving a 2020-2021, 2021-2022, or 2022-2023 inactivated influenza vaccine two weeks prior to ofatumumab start	Cohort 2 n=22 participants at risk Patients with relapsing MS receiving a 2020-2021, 2021-2022, 2022-2023 inactivated influenza vaccine at least 4 weeks after ofatumumab start	Cohort 3 n=19 participants at risk Patients with relapsing MS currently on iDMT receiving a 2020-2021, 2021-2022, or 2022-2023 inactivated influenza vaccine
Gastrointestinal disorders Abdominal mass	4.5% 1/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/19 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)
Gastrointestinal disorders Nausea	13.6% 3/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/19 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)
General disorders Chills	9.1% 2/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/19 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)
General disorders Fatigue	9.1% 2/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/19 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)
General disorders Influenza like illness	9.1% 2/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	4.5% 1/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/19 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)
General disorders Injection site reaction	4.5% 1/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/19 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)
General disorders Injury associated with device	4.5% 1/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/19 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)
General disorders Pain	13.6% 3/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/19 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)
General disorders Peripheral swelling	4.5% 1/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/19 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)
General disorders Pyrexia	9.1% 2/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	5.3% 1/19 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)
Infections and infestations Bronchitis	4.5% 1/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/19 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)
Infections and infestations COVID-19	9.1% 2/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	5.3% 1/19 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)
Infections and infestations Herpes zoster	0.00% 0/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	4.5% 1/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/19 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)
Infections and infestations Influenza	4.5% 1/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/19 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)
Infections and infestations Upper respiratory tract infection	4.5% 1/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/19 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)
Infections and infestations Urinary tract infection	9.1% 2/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/19 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)
Injury, poisoning and procedural complications Injection related reaction	18.2% 4/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/19 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)
Injury, poisoning and procedural complications Muscle strain	0.00% 0/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	4.5% 1/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/19 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)
Investigations SARS-CoV-2 test positive	4.5% 1/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	4.5% 1/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/19 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)
Metabolism and nutrition disorders Polydipsia	4.5% 1/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/19 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)
Musculoskeletal and connective tissue disorders Back pain	4.5% 1/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/19 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)
Musculoskeletal and connective tissue disorders Muscle spasms	4.5% 1/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	9.1% 2/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/19 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)
Musculoskeletal and connective tissue disorders Pain in extremity	4.5% 1/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	4.5% 1/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/19 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)
Nervous system disorders Balance disorder	0.00% 0/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	4.5% 1/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/19 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)
Nervous system disorders Headache	13.6% 3/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	4.5% 1/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/19 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)
Nervous system disorders Hypoaesthesia	4.5% 1/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	5.3% 1/19 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)
Nervous system disorders Migraine	4.5% 1/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/19 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)
Nervous system disorders Paraesthesia	0.00% 0/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	5.3% 1/19 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)
Psychiatric disorders Generalised anxiety disorder	4.5% 1/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/19 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	4.5% 1/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/19 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)
Skin and subcutaneous tissue disorders Alopecia	4.5% 1/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/19 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)
Skin and subcutaneous tissue disorders Skin wrinkling	0.00% 0/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	4.5% 1/22 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)	0.00% 0/19 • From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)