Evidence map›Paper›PMID 28955715›Full record

ArticleNeurology(R) neuroimmunology & neuroinflammation2017

Impact of siponimod on vaccination response in a randomized, placebo-controlled study.

Mike Ufer, Kasra Shakeri-Nejad, Anne Gardin, Zhenzhong Su, Ines Paule, Thomas C Marbury, Eric Legangneux

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Neurology(R) neuroimmunology & neuroinflammation, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 2 pooled it
0.7field-weighted citation impact, top 31% 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

24 citing papers in PubMed, 2 syntheses or guidelines pooled it, 36 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Review
  5. Review
  6. Article
  7. Review
  8. Article
  9. Article
  10. Review
  11. Article
  12. Article
  13. Article
  14. Article
  15. Review
  16. Article
  17. Review
  18. Review
  19. Article
  20. Article
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

7 authors at 1 institution in 2 countries.

Mike UferNovartis Pharma AG (M.U., K.S.-N., A.G., Z.S., I.P., E.L.), Basel, Switzerland; and Orlando Clinical Research Center (T.C.M.), Orlando, FL.
Kasra Shakeri-NejadNovartis Pharma AG (M.U., K.S.-N., A.G., Z.S., I.P., E.L.), Basel, Switzerland; and Orlando Clinical Research Center (T.C.M.), Orlando, FL.
Anne GardinNovartis Pharma AG (M.U., K.S.-N., A.G., Z.S., I.P., E.L.), Basel, Switzerland; and Orlando Clinical Research Center (T.C.M.), Orlando, FL.
Zhenzhong SuNovartis Pharma AG (M.U., K.S.-N., A.G., Z.S., I.P., E.L.), Basel, Switzerland; and Orlando Clinical Research Center (T.C.M.), Orlando, FL.
Ines PauleNovartis Pharma AG (M.U., K.S.-N., A.G., Z.S., I.P., E.L.), Basel, Switzerland; and Orlando Clinical Research Center (T.C.M.), Orlando, FL.
Thomas C MarburyNovartis Pharma AG (M.U., K.S.-N., A.G., Z.S., I.P., E.L.), Basel, Switzerland; and Orlando Clinical Research Center (T.C.M.), Orlando, FL.
Eric LegangneuxNovartis Pharma AG (M.U., K.S.-N., A.G., Z.S., I.P., E.L.), Basel, Switzerland; and Orlando Clinical Research Center (T.C.M.), Orlando, FL.
Novartis (Switzerland) · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate effects of siponimod on response to T-cell-dependent (influenza) and T-cell-independent (pneumococcal polysaccharide vaccine [PPV-23]) vaccinations in healthy participants.

methodsIn this double-blind, placebo-controlled, parallel-group study, each participant underwent a 7-week treatment period and received intramuscular injections of influenza and PPV-23 vaccines (day 21). Participants were randomized to 4 treatment groups (N = 30 each) and received placebo or siponimod 2 mg once daily in concomitant, interrupted, or preceding fashion. Individual response to vaccination was defined by a ≥4-fold (influenza) antibody titer increase and by a ≥2-fold increase in serotype-specific immunoglobulin (Ig) G concentrations (PPV-23) on day 28 vs baseline. Responder rates were compared using noninferiority analysis.

resultsMean influenza titers were similar to placebo in the preceding and interrupted groups but lower in the concomitant group. The proportion of participants with influenza titers ≥40 four weeks after vaccination (seroprotection) was similar to placebo across all groups and antigens. In each treatment group, response criteria were met for 3 of 4 antigens including H1N1 and H3N2. A noninferior response was determined in the context of preceding treatment but not interrupted or concomitant treatment. Regarding PPV-23, approximately 90%-100% of participants exhibited a ≥2-fold increase in IgG concentrations vs baseline. Noninferior responder rates were determined for each siponimod treatment group.

conclusionsSiponimod treatment had no relevant effect on antibody response to PPV-23. European Medicines Agency response criteria were essentially met for influenza, but titers were lower on concomitant treatment. Overall, these data suggest that siponimod has limited effect on the efficacy of vaccinations with neoantigens. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that in healthy persons, siponimod had limited effect on the immune response following influenza or pneumococcal vaccinations.

Identifiers

PMID28955715
PMCPMC5608565
OpenAlexW2754801076

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.