HERCULES was a unique trial design in nrSPMS, a population progressing independent of relapses 1,2
Not relapsing:
≥2 years since most recent relapse, with a mean of 7.4 years1,5
Progressing: All patients had documented disability progression in the 12 months prior to baseline1
Majority without MRI activity: ~87% of patients had no active Gd+ lesions at baseline1,6-10
Range of age: 50% of patients were ≤50 years old2,5
CENRIFKI was studied in a range of EDSS scores: 40% of patients had an EDSS ≤5.5 at baseline1,2,5
Patient portrayal and hypothetical scenario.
Age: 52
Occupation: House wife
CLINICAL CHARACTERISTICS
Time since diagnosis: 15 years
Time since last relapse: 7 years
Level of disability: Moderate. Her EDSS Score is 4.5 and, despite no EDSS change, her symptoms have worsened in the past 12 months due to disability progression
MRI activity: No active lesions in the past 7 years
Current treatment: On anti-CD20 since last relapse
SYMPTOMS OF DISABILITY
- Her Husband has taken over physically demanding household chores and grocery shopping, which Nora used to do independently
-
Notes from last year’s visit show she was walking several blocks daily with ease—now she finds herself needing to pause more frequently and limits how far she goes
What is your current treatment goal for Nora? |
Patient portrayal and hypothetical scenario.
Age: 43
Occupation: Engineer
CLINICAL CHARACTERISTICS
Time since diagnosis: 10 years
Time since last relapse: 4 years
Level of disability: Mild-to-moderate (EDSS score change from 2.5 to 3.5 over the last 12 months)
MRI activity: No active lesions in the past 4 years
Current treatment: On anti-CD20 since last relapse
SYMPTOMS OF DISABILITY
- His wife has noticed that he trips more frequently and had a fall a few months ago
- He has also begun experiencing increased urinary urgency, occasionally needing to locate a restroom quickly when away from home—a change noted in the past year
- Ahmed has mentioned increasing difficulty with his regular work tasks—something both he and his coworkers have started to notice
Do you believe that Ahmed's treatment is still meeting his needs? |
Patient portrayal and hypothetical scenario.
Age: 38
Occupation: Nurse
CLINICAL CHARACTERISTICS
Time since diagnosis: 7 years
Time since last relapse: 2 years
Level of disability: Mild-to-moderate (EDSS score change from 2.0 to 3.0 over the last 12 months)
MRI activity: No active lesions in the past 2 years
Current treatment: On anti-CD20 since last relapse
SYMPTOMS OF DISABILITY
- Yasmine has started experiencing leg weakness and mild foot drag, which causes her to walk more cautiously and take breaks more frequently
- Since her last visit 6 months ago, she told her doctor that she has begun to notice an increased urgency and mild hesitancy when urinating
- Her coworkers have noticed that Yasmine needs to spend more time sitting during the day due to fatigue
Do you believe that Yasmine's treatment is still meeting her needs? |
Patient portrayal and hypothetical scenario.
Age: 52
Occupation: House wife
CLINICAL CHARACTERISTICS
Time since diagnosis: 15 years
Time since last relapse: 7 years
Level of disability: Moderate. Her EDSS Score is 4.5 and, despite no EDSS change, her symptoms have worsened in the past 12 months due to disability progression
MRI activity: No active lesions in the past 7 years
Current treatment: On anti-CD20 since last relapse
SYMPTOMS OF DISABILITY
- Her Husband has taken over physically demanding household chores and grocery shopping, which Nora used to do independently
-
Notes from last year’s visit show she was walking several blocks daily with ease—now she finds herself needing to pause more frequently and limits how far she goes
What is your current treatment goal for Nora? |
Patient portrayal and hypothetical scenario.
Age: 43
Occupation: Engineer
CLINICAL CHARACTERISTICS
Time since diagnosis: 10 years
Time since last relapse: 4 years
Level of disability: Mild-to-moderate (EDSS score change from 2.5 to 3.5 over the last 12 months)
MRI activity: No active lesions in the past 4 years
Current treatment: On anti-CD20 since last relapse
SYMPTOMS OF DISABILITY
- His wife has noticed that he trips more frequently and had a fall a few months ago
- He has also begun experiencing increased urinary urgency, occasionally needing to locate a restroom quickly when away from home—a change noted in the past year
- Ahmed has mentioned increasing difficulty with his regular work tasks—something both he and his coworkers have started to notice
Do you believe that Ahmed's treatment is still meeting his needs? |
Patient portrayal and hypothetical scenario.
Age: 38
Occupation: Nurse
CLINICAL CHARACTERISTICS
Time since diagnosis: 7 years
Time since last relapse: 2 years
Level of disability: Mild-to-moderate (EDSS score change from 2.0 to 3.0 over the last 12 months)
MRI activity: No active lesions in the past 2 years
Current treatment: On anti-CD20 since last relapse
SYMPTOMS OF DISABILITY
- Yasmine has started experiencing leg weakness and mild foot drag, which causes her to walk more cautiously and take breaks more frequently
- Since her last visit 6 months ago, she told her doctor that she has begun to notice an increased urgency and mild hesitancy when urinating
- Her coworkers have noticed that Yasmine needs to spend more time sitting during the day due to fatigue
Do you believe that Yasmine's treatment is still meeting her needs? |
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Learn more about the results of the HERCULES trial.
CD20=cluster of differentiation 20; EDSS=Expanded Disability Status Scale; MRI=magnetic resonance imaging; MS=multiple sclerosis; nrSPMS=non-relapsing secondary progressive multiple sclerosis.
▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side affects you may get.
References
1. CENRIFKI [Prescribing Information] UAE SmPC 2. Fox RJ, Bar-Or A, Traboulsee, et al. Tolebrutinib in nonrelapsing secondary progressive multiple sclerosis. N Engl J Med. 2025;392(19):1883-1892. 3. Fox RJ, Bar-Or A, Traboulsee A, et al. Baseline characteristics in the tolebrutinib phase 3 non-relapsing secondary progressive multiple sclerosis (nrSPMS) HERCULES clinical trial. Poster presented at the 9th Joint ECTRIMS-ACTRIMS Meeting. October 11-13; 2023; Milan, Italy. P1476. 4. Oh J, Arnold DL, Cree BAC, et al. Efficacy and safety of tolebrutinib versus teriflunomide in relapsing multiple sclerosis: results from the phase 3 GEMINI 1 and 2 Trials. Presented at: 40th Annual European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS); September 18-20, 2024; Copenhagen, Denmark. 5. Fox RJ, Bar-Or A, Traboulsee A, et al. Efficacy and safety of tolebrutinib versus placebo in non-relapsing secondary progressive multiple sclerosis: results from the phase 3 HERCULES trial. Presented at the 4th Annual European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). September 18-20, 2024; Copenhagen, Denmark. #1036.
INDICATION