Evidence map›Paper›PMID 35451662›Full record

ReviewWiener medizinische Wochenschrift (1946)2022

Real-world evidence for cladribine tablets in multiple sclerosis: further insights into efficacy and safety.

Tobias Moser, Tjalf Ziemssen, Johann Sellner

Open access · hybridAbstract readReview
In one paragraph

Review in Wiener medizinische Wochenschrift (1946), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
2.8field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 22 citations in OpenAlex.

  1. Trial
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  3. Article
  4. Observational
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  6. Article
  7. Long-term impact of oral cladribine on humoral immunity in multiple sclerosis.Therapeutic advances in neurological disorders · 2025
    Article
  8. Article
  9. Article
  10. Review
  11. Article
  12. Observational
  13. Review
  14. Review
  15. Article
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  17. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors at 2 institutions in 2 countries.

Tobias MoserDepartment of Neurology, Christian Doppler Medical Center, Paracelsus Medical University, Salzburg, Austria.
Tjalf ZiemssenDepartment of Neurology, Multiple Sclerosis Center, Center of Clinical Neuroscience, Carl Gustav Carus University Hospital, Technical University Dresden, Dresden, Germany.
Johann SellnerDepartment of Neurology, Christian Doppler Medical Center, Paracelsus Medical University, Salzburg, Austria. johann.sellner@mistelbach.lknoe.at.ORCID http://orcid.org/0000-0001-8749-5533
Paracelsus Medical University · ATUniversity Hospital Carl Gustav Carus · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Cladribine (CLAD) is a purine nucleoside analog approved in tablet form to treat highly active multiple sclerosis (MS). CLAD tablets are the first oral therapy with an infrequent dosing schedule, administered in two annual treatment courses, each divided into two treatment cycles comprising 4-5 days of treatment. The efficacy and safety of CLAD tablets have been verified in randomized controlled clinical trials. Clinical observational studies are performed in more representative populations and over more extended periods, and thus provide valuable complementary insights. Here, we summarize the available evidence for CLAD tablets from post-marketing trials, including two observational, four long-term extensions, and two comparative studies. The patients in the post-marketing setting differed from the cohort recruited in the pivotal phase III trials regarding demographics and MS-related disability. The limited number of studies with small cohorts corroborate the disease-modifying capacity of oral CLAD and report on a durable benefit after active treatment periods. Skin-related adverse events were common in the studies focusing on safety aspects. In addition, single cases of CLAD-associated autoimmune events have been reported. Lastly, CLAD tablets appear safe regarding COVID-19 concerns, and patients mount a robust humoral immune response to SARS-CoV‑2 vaccination. We conclude that the current real-world evidence for CLAD tablets as immune reconstitution therapy for treatment of MS is based on a small number of studies and a population distinct from the cohorts randomized in the pivotal phase III trials. Further research should advance the understanding of long-term disease control after active treatment periods and the mitigation of adverse events.

Indexed as

COVID-19Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingCladribineCOVID-19 VaccinesHumansImmunosuppressive AgentsNucleosidesSARS-CoV-2TabletsCladribineCOVID-19 VaccinesImmunosuppressive AgentsNucleosidesTabletsCladribinEfficacyReal-world dataSafetySARS-CoV‑2

Identifiers

PMID35451662
PMCPMC9026047
OpenAlexW4224247956

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.