Evidence map›Paper›PMID 26539981›Full record

Trial reportPloS one2015

Efficacy of Rituximab in Refractory Inflammatory Myopathies Associated with Anti- Synthetase Auto-Antibodies: An Open-Label, Phase II Trial.

Yves Allenbach, Marguerite Guiguet, Aude Rigolet, Isabelle Marie, Eric Hachulla, Laurent Drouot, Fabienne Jouen, Serge Jacquot, Kuberaka Mariampillai, Lucile Musset and 6 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00774462 (FORCE), which is not on this map. Cited by 59 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
59citing papers in PubMed, 5 pooled it
6.1field-weighted citation impact, top 3% 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.

NCT00774462 phase2completednot on this map

FORCE: Rituximab (CD 20+-B Cell-depleting Monoclonal Antibody) for the Treatment of Refractory Inflammatory Myopathies With Specific Antibodies and Refractory Myasthenia Gravis

TypeinterventionalSponsorAssistance Publique - Hôpitaux de ParisRan2008 to 2011Enrolled30ConditionsMyositis, Myasthenia GravisArmsRituximab
3 · Its place in the literature

Who cites it

59 citing papers in PubMed, 5 syntheses or guidelines pooled it, 123 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Defining anti-synthetase syndrome: a systematic literature review.Clinical and experimental rheumatology · 2022
    Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Article
  8. Emerging therapies in idiopathic inflammatory myopathies.Journal of neuromuscular diseases · 2026
    Review
  9. Article
  10. Review
  11. Review
  12. Article
  13. Review
  14. Article
  15. Review
  16. Article
  17. Article
  18. Review
  19. Observational
  20. Review
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

16 authors at 9 institutions in 1 country.

Yves AllenbachDépartement de Médecine Interne et Immunologie Clinique, Centre de Référence des Pathologies Neuromusculaires Paris Est, UPMC, APHP, INSERM, UMR 974, DHU i2B, Hôpital Pitié-Salpêtrière, Paris, France.
Marguerite GuiguetDépartement de Biostatistique, UMRS 943, UPMC, INSERM, Paris, France.
Aude RigoletDépartement de Médecine Interne et Immunologie Clinique, Centre de Référence des Pathologies Neuromusculaires Paris Est, UPMC, APHP, INSERM, UMR 974, DHU i2B, Hôpital Pitié-Salpêtrière, Paris, France.
Isabelle MarieDépartement de Médecine Interne, Hôpital Charles Nicole, Rouen, France.
Eric HachullaCentre de Référence pour les maladies auto-immunes systémiques rares (Sclérodermie) Hôpital Claude Huriez, Université Lille 2, Lille, France.
Laurent DrouotDépartement d'Immunologie, U905, Université Rouen Normandie, INSERM, Hôpital Universitaire de Rouen, Rouen, France.
Fabienne JouenDépartement d'Immunologie, U905, Université Rouen Normandie, INSERM, Hôpital Universitaire de Rouen, Rouen, France.
Serge JacquotDépartement d'Immunologie, U905, Université Rouen Normandie, INSERM, Hôpital Universitaire de Rouen, Rouen, France.
Kuberaka MariampillaiDépartement de Médecine Interne et Immunologie Clinique, Centre de Référence des Pathologies Neuromusculaires Paris Est, UPMC, APHP, INSERM, UMR 974, DHU i2B, Hôpital Pitié-Salpêtrière, Paris, France.
Lucile MussetLaboratoire d'Immunochimie, Hôpital Pitié-Salpêtrière, UPMC, APHP, Paris, France.
Philippe GrenierDépartement de radiologie générale, Hôpital Pitié-Salpêtrière, UPMC, APHP, Paris, France.
Herve DevilliersDépartement de médecine Interne, Hôpital Universitaire Dijon, Dijon, France.
Adrian HijDépartement de Médecine Interne et Pathologie Vasculaire, Hôpital Saint Louis, Université Paris 7, APHP, Paris, France.
Olivier BoyerDépartement d'Immunologie, U905, Université Rouen Normandie, INSERM, Hôpital Universitaire de Rouen, Rouen, France.
Serge HersonDépartement de Médecine Interne et Immunologie Clinique, Centre de Référence des Pathologies Neuromusculaires Paris Est, UPMC, APHP, INSERM, UMR 974, DHU i2B, Hôpital Pitié-Salpêtrière, Paris, France.
Olivier BenvenisteDépartement de Médecine Interne et Immunologie Clinique, Centre de Référence des Pathologies Neuromusculaires Paris Est, UPMC, APHP, INSERM, UMR 974, DHU i2B, Hôpital Pitié-Salpêtrière, Paris, France.
Sorbonne Université · FRAssistance Publique – Hôpitaux de Paris · FRBiotherapy of Genetic Diseases, Inflammatory Disorders and Cancers · FRPhysiopathologie, autoimmunité, maladies neuromusculaire et thérapie régénératricePitié-Salpêtrière Hospital · FRCentre Hospitalier Universitaire Dijon Bourgogne · FRHôpital Claude Huriez · FRHôpital Saint-Louis · FRUniversité de Rouen Normandie · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveAnti-synthetase syndrome (anti-SS) is frequently associated with myositis and interstitial lung disease (ILD). We evaluated prospectively, in a multicenter, open-label, phase II study, the efficacy of rituximab on muscle and lung outcomes.

methodsPatients were enrolled if they were refractory to conventional treatments (prednisone and at least 2 immunosuppressants). They received 1 g of rituximab at D0, D15, and M6. The primary endpoint was muscular improvement based on manual muscular testing (MMT10, Kendall score in 10 muscles) at M12. Secondary endpoints were normalization of creatine kinase (CK) level, ILD improvement based on forced vital capacity and/or diffuse capacity for carbon monoxide, and number and/or doses of associated immunosuppressants.

resultsTwelve patients were enrolled, and 10 completed the study. Only 2 patients presented an improvement of at least 4 points on at least two muscle groups (primary end-point). Overall, seven patients had an increase of at least 4 points on MMT10. CK level decreased from 399 IU/L (range, 48-11,718) to 74.5 IU/L (range, 40-47,857). Corticosteroid doses decreased from 52.5 mg/d (range, 10-70) to 9 mg/d (range, 7-65) and six patients had a decrease in the burden of their associated immunosuppressants. At baseline, all 10 patients presented with ILD. At M12, improvement of ILD was observed in 5 out of the 10 patients, stabilization in 4, and worsening in 1.

conclusionsThis pilot study of rituximab treatment in patients with refractory anti-SS provided data on evolution of muscular and pulmonary parameters. Rituximab should now be evaluated in a larger, controlled study for this homogenous group of patients.

trial registrationClinicaltrials.gov NCT00774462.

Indexed as

AdultAutoantibodiesCreatine KinaseFemaleHumansImmunologic FactorsMaleMiddle AgedMyositisRituximabTreatment OutcomeVital CapacityYoung AdultAutoantibodiesCreatine KinaseImmunologic FactorsRituximab

Identifiers

PMID26539981
PMCPMC4634756
OpenAlexW2110201345

What OpenQuestion holds

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Registered trials

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.