Changes in Immune Cell Types in RRMS Patients Treated with Cladribine
In a small observational study of 10 patients with relapsing-remitting multiple sclerosis (RRMS) treated with oral cladribine over 96 weeks, significant changes in immune cell populations were observed. Class-switched memory B cells decreased by 62.8%, non-class-switched memory B cells by 85.3%, and plasmablasts increased by 117.2%.
- Tags
- #MSResearch
- Most relevant to
- —
- Source
- Read original source
- Human efficacy
- Not established from this source
- Mechanism
- Not reported
- Evidence strength
- Limited
- Outcome
- Not reported
Why it matters
These findings suggest that cladribine may have a substantial impact on certain immune cell types in MS patients. However, the small sample size and lack of peer-reviewed publication limit the strength of these results, and causative relationships cannot be confirmed from observational data alone.
What this does not prove
The study lacks peer-reviewed published results, and the findings are based solely on registry data, which limits the ability to draw firm conclusions about causation.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Observational
- Participants / samples
- 10 · actual enrolment
- Randomised
- Not reported
- Controlled
- Not reported
- Primary endpoint met
- Not reported
- Relevant MS type
- Not reported
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- Not reported
- Research areas
- Not classified
- Biological target
- Not reported
- Pathway
- Not reported
- Population
- participants with RRMS
- Size of effect
- Not reported
- Secondary endpoints
- Not reported
- MRI endpoints
- Not reported
- Biomarkers
- Not reported
- Safety
- Not reported
Original sources
- Trial registrationOral Cladribine B-cell Study ↗
Supporting passages (11)
study designStudy type: Observational
subjectsParticipants: people; sex All
sample sizeEnrollment: 10 participants (actual)
interventionCladribine (Mavenclad, Merck Serono Ltd)
findings"detailedDescription": "Primary: To quantify the temporal changes of memory B cells (CD19+/CD27+/IgD-/+), plasmablasts (CD19-/CD138+/CD38+) and T cells (CD4/CD45RA-/+, CCR7-/+, CD8+/CD45RA-/+/CCR7-/+), Tregs (CD4/CD8)/CD25+/CD127-/Fox3 P+) in the peripheral venous blood of pwMS with RRMS over 96w of treatment with oral cladribine.\n\nThese will be compared to the populations of non-memory or class-switched B cells (immature/transitional B cells CD10+/CD38+/CD19+, immature regulatory B cells CD10+/CD38+/CD19+/CD24+/IL-10+, mature B cells CD10-/CD38+/CD19+).\n\nSecondary:\n\n1.
populationParticipants: people; sex All
limitationsTrial registry record. Publication date: unknown. Sponsor-submitted results are available; this does not establish peer review.
peer reviewedTrial registry record.
primary endpointPrimary endpoints: Percent Change in Class-switched Memory B Cells From Baseline to Week 96 nh; Percent Change in Non Class-switched Memory B Cells From Baseline to Week 96; Percent Change in Plasmablast From Baseline to Week 96; Percent Change in Transitional B Cells From Baseline to Week 96; Percent Change in Regulatory B Cells From Baseline to Week 96; Percent Change in CD4+ Central Memory T Cells From Baseline to Week 96; Percent Change in CD4+ Naive T Cells From Baseline to Week 96; Percent Change in CD4+ TEMRA Cells From Baseline to Week 96; Percent Change in CD4+ Effector Memory T Cells From Baseline to Week 96; Percent Change in CD8+ Central Memory T Cells From Baseline to Week 96; Percent Change in CD8+ Naive T Cells From Baseline to Week 96; Percent Change in CD8+ TEMRA Cells From Baseline to Week 96; Percent Change in CD8+ TEM Cells From Baseline to Week 96; Percent Change in Regulatory T Cells From Baseline to Week 96
follow upFollow-up: Baseline to week 96; Baseline to 96 weeks
sample size basisEnrollment: 10 participants (actual)
AI assessment, not yet reviewed by a person · version 1 · Community votes are separate from evidence review.