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Background <p>Relapsing-remitting multiple sclerosis (RRMS) often necessitates treatment changes due to safety concerns, inadequate efficacy, or patient-specific factors. While second-line therapies (e.g., natalizumab, ocrelizumab) are effective, real-world evidence on outcomes after switching or discontinuing these therapies are limited, particularly in diverse healthcare settings.</p> Objective <p>This study aimed to evaluate treatment transition patterns, reasons for discontinuation, and six-month clinical/MRI outcomes in patients with RRMS switching between second-line therapies or discontinuing treatment.</p> Methods <p>A retrospective cohort study was conducted at Sina Hospital, Tehran, Iran, including 338 RRMS patients who switched or discontinued second-line therapies including fingolimod, natalizumab, ocrelizumab and rituximab. Clinical and MRI data were collected at baseline (therapy change/discontinuation) and six-month follow-up. Outcomes included relapse frequency, disability progression (Expanded Disability Status Scale [EDSS]), and MRI lesion activity. Statistical analysis was done using paired t-tests and descriptive statistics.</p> Results <p>Among 338 patients (83.1% female, mean age 33.9 years), treatment transitions occurred most frequently to ocrelizumab (42.3%) or rituximab (33.4%). Safety concerns (32.0%), inadequate efficacy (29.9%), tolerability issues (13.6%), and pregnancy planning (8.9%) were primary reasons for therapy changes. Overall paired analyses of EDSS scores showed a strong correlation between pre- and post-switch measurements (r = 0.944, p &lt; 0.001), although the average change for the entire cohort was minimal and not statistically significant. Notably, the subgroup of patients who switched from fingolimod to ocrelizumab demonstrated a statistically significant reduction in EDSS scores, with a mean difference of 0.19 (p = 0.019). Furthermore, among 110 patients whose treatment change was driven solely by inadequate efficacy (e.g., ongoing relapses or poor symptom control), the mean EDSS improved significantly from 2.41 (± 1.74) at baseline to 2.16 (± 1.80) at six months, with a mean difference of 0.25 (p &lt; 0.001) and a strong correlation between baseline and follow-up scores (r = 0.92, p &lt; 0.001).</p> Conclusion <p>B-cell-depleting therapies, particularly ocrelizumab, may help lower disability in active RRMS, but longer follow-up is needed to confirm sustained benefits. Personalized strategies that balance efficacy, safety, and patient-specific factors (e.g., PML risk, pregnancy) are essential. Although most patients had low baseline disability, which may limit generalizability, these findings still offer real-world insight into treatment transitions. Longer prospective studies are needed to confirm long-term outcomes.</p>

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Exit strategy patterns in second-line therapies for relapsing forms of multiple sclerosis

  • 期刊论文

  • 发表日期：

    2026年1月30日

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  • Ali Rezaei,
  • Nasim Rezaeimanesh,
  • Kosar Kohandel,
  • Sareh Shahmohammadi,
  • Shima Jahani,
  • Amirreza Azimi,
  • Abdorreza Naser Moghadasi,
  • Mohammad Ali Sahraian

摘要

Background

Relapsing-remitting multiple sclerosis (RRMS) often necessitates treatment changes due to safety concerns, inadequate efficacy, or patient-specific factors. While second-line therapies (e.g., natalizumab, ocrelizumab) are effective, real-world evidence on outcomes after switching or discontinuing these therapies are limited, particularly in diverse healthcare settings.

Objective

This study aimed to evaluate treatment transition patterns, reasons for discontinuation, and six-month clinical/MRI outcomes in patients with RRMS switching between second-line therapies or discontinuing treatment.

Methods

A retrospective cohort study was conducted at Sina Hospital, Tehran, Iran, including 338 RRMS patients who switched or discontinued second-line therapies including fingolimod, natalizumab, ocrelizumab and rituximab. Clinical and MRI data were collected at baseline (therapy change/discontinuation) and six-month follow-up. Outcomes included relapse frequency, disability progression (Expanded Disability Status Scale [EDSS]), and MRI lesion activity. Statistical analysis was done using paired t-tests and descriptive statistics.

Results

Among 338 patients (83.1% female, mean age 33.9 years), treatment transitions occurred most frequently to ocrelizumab (42.3%) or rituximab (33.4%). Safety concerns (32.0%), inadequate efficacy (29.9%), tolerability issues (13.6%), and pregnancy planning (8.9%) were primary reasons for therapy changes. Overall paired analyses of EDSS scores showed a strong correlation between pre- and post-switch measurements (r = 0.944, p < 0.001), although the average change for the entire cohort was minimal and not statistically significant. Notably, the subgroup of patients who switched from fingolimod to ocrelizumab demonstrated a statistically significant reduction in EDSS scores, with a mean difference of 0.19 (p = 0.019). Furthermore, among 110 patients whose treatment change was driven solely by inadequate efficacy (e.g., ongoing relapses or poor symptom control), the mean EDSS improved significantly from 2.41 (± 1.74) at baseline to 2.16 (± 1.80) at six months, with a mean difference of 0.25 (p < 0.001) and a strong correlation between baseline and follow-up scores (r = 0.92, p < 0.001).

Conclusion

B-cell-depleting therapies, particularly ocrelizumab, may help lower disability in active RRMS, but longer follow-up is needed to confirm sustained benefits. Personalized strategies that balance efficacy, safety, and patient-specific factors (e.g., PML risk, pregnancy) are essential. Although most patients had low baseline disability, which may limit generalizability, these findings still offer real-world insight into treatment transitions. Longer prospective studies are needed to confirm long-term outcomes.