Home›Neurology› Cladribine tablets reduce annualized relapse rate by 58% compared to placebo in active RRMS
Cladribine tablets reduce annualized relapse rate by 58% compared to placebo in active RRMSCladribine tablets show promise for managing relapsing-remitting multiple sclerosis
Multiple sclerosis and related disordersPublished July 1, 2026Study authors: Harty Gerard T, Jones Michelle, Maheshwari Vikalp, Saipriya JPubMed ↗DOI ↗Editorial oversight: Dr. Ji-eun Park, MD · Brain, Mind & Pain
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Key Takeaway
Consider cladribine as a comparably effective and safe oral option for reducing relapse rates in active RRMS.
This systematic review and network meta-analysis included 66 studies to evaluate the efficacy and safety of cladribine tablets for patients with active relapsing-remitting multiple sclerosis (RRMS). The analysis compared cladribine against placebo and several other disease-modifying treatments (DMTs), including ofatumumab, ublituximab, alemtuzumab, natalizumab, ocrelizumab, and interferon beta-1a.
The primary finding was a 58% reduction in annualized relapse rate (ARR) for cladribine versus placebo. The analysis indicated that cladribine performed similarly to or significantly better than other DMT regimens. Regarding confirmed disease progression (CDP) at 6 months, cladribine was significantly greater than placebo, though no other comparator DMT demonstrated significantly better results.
From a safety perspective, the overall adverse event risk for clad1rine tablets was statistically comparable to all other oral DMTs and both interferon beta-1a regimens. While effective, it is noted that cladribine ranked sixth among the evaluated DMTs for both efficacy endpoints, following ofatumumab, ublituximab, alemtuzumab, natalizumab, and ocrelizumab. These findings suggest cladribine is a viable and safe option for RRMS management.
How this fits prior evidence
This finding addresses a gap in comparing multiple disease-modifying treatments for relapsing-remitting multiple sclerosis. While prior evidence confirmed that ocrelizumab reduces disability progression risk in primary progressive multiple sclerosis and shows disability improvement in relapsing forms, this meta-analysis provides specific comparative data for cladribine. It establishes cladribine as a comparable alternative to other DMTs like ocrelizumab, which was previously noted to show different disability effects across MS subtypes.
Living with relapsing-remitting multiple sclerosis (RRMS) means dealing with unpredictable flare-ups and the constant worry of how the disease will progress over time. Managing these symptoms requires reliable treatments that can keep the condition stable while remaining safe for the patient.
A large review of 66 different studies looked at how cladribine tablets compare to other common medications for RRMS. The results showed that clad1rine significantly reduced the annual relapse rate by 58% compared to a placebo. It also performed better than a placebo in slowing down confirmed disease progression over a six-month period.
While cladribine was found to be an effective and safe option, it did not rank as the top performer among all tested drugs. However, its safety profile was comparable to other oral treatments and interferon beta-1a regimens. This makes it a reliable alternative for patients seeking to manage their symptoms effectively.
What this means for you:
Cladribine tablets significantly reduce relapse rates and are a safe option for managing relapsing-remitting multiple sclerosis.
Common questions
How effective is cladribine for relapsing-remitting multiple sclerosis?
Cladribine tablets showed a 58% reduction in the annual relapse rate compared to a placebo. The study also found that it was significantly better than a placebo at slowing confirmed disease progression over a six-month period.
Is cladribine safe to take for MS?
The review found that the risk of adverse events for cladribine tablets was statistically comparable to other oral medications and interferon beta-1a regimens. It is considered a safe alternative to many currently approved treatments.
How does cladribine compare to other MS medications?
While cladribine is effective, it ranked sixth among the drugs tested for both efficacy endpoints. However, it remains a comparable and safe option when compared to other oral treatments like ocrelizumab or natalizumab.
BACKGROUND: To update previous work assessing the relative efficacy and safety of cladribine tablets compared to currently approved disease-modifying treatments (DMTs) in patients with active relapsing-remitting multiple sclerosis (RRMS), using systematic literature review (SLR) and network meta-analysis (NMA).
METHODS: Systematic literature searches were conducted in MEDLINE, Embase, MEDLINE In-Process and CENTRAL databases to identify English-language publications of relevant studies of approved DMTs for RRMS. Searches were conducted from database inception to January 2017, and then further updated from January 2017 to September 2022. Conference websites and trial registries were also searched. NMA considered the effects of DMTs on annualized relapse rate (ARR), confirmed disease progression (CDP), proportion relapse-free (RF), and safety.
RESULTS: Of 21,181 unique articles retrieved and screened, 66 studies met the inclusion criteria and had their data extracted, including 17 new studies since the previous review; of these, 57 studies assessing 20 DMTs contributed to the NMA. In patients with active RRMS, cladribine tablets were associated with a significant 58% reduction in ARR versus placebo; cladribine tablets were similar or significantly better than other DMT regimens. For 6-month CDP, improvements with cladribine tablets were significantly greater than those of placebo, with no comparator DMT demonstrating significantly better results. For both efficacy endpoints, cladribine tablets ranked sixth among DMTs, behind ofatumumab, ublituximab, alemtuzumab, natalizumab, and ocrelizumab. The overall adverse event risk for cladribine tablets was statistically comparable to all other oral DMTs and both interferon beta-1a regimens.
CONCLUSIONS: In this updated SLR and NMA, cladribine tablets remain a comparatively effective and safe alternative to other currently approved DMTs in populations of patients with active RRMS.
