Evidence map›Paper›PMID 34313812›Full record

Trial reportRheumatology international2021

Tofacitinib in the treatment of skin and musculoskeletal involvement in patients with systemic sclerosis, evaluated by ultrasound.

Rositsa Valerieva Karalilova, Zguro Anastasov Batalov, Tanya Lyubomirova Sapundzhieva, Marco Matucci-Cerinic, Anastas Zgurov Batalov

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Rheumatology international, 2021. 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
5.8field-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.

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, 49 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Article
  4. Review
  5. Review
  6. Article
  7. Article
  8. Article
  9. Review
  10. Observational
  11. Emerging therapeutic targets in systemic sclerosis.Journal of molecular medicine (Berlin, Germany) · 2024
    Review
  12. Article
  13. Article
  14. Biomarkers in Systemic Sclerosis: An Overview.Current issues in molecular biology · 2023
    Review
  15. Review
  16. Successful Use of Tofacitinib in Scleroderma Arthropathy.Mediterranean journal of rheumatology · 2023
    Article
  17. Review
  18. Review
  19. Article
  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

5 authors at 2 institutions in 2 countries.

Rositsa Valerieva Karalilova *Department of Internal Diseases, Medical University of Plovdiv, Plovdiv, Bulgaria. karalilova@hotmail.com.ORCID http://orcid.org/0000-0001-8030-0529
Zguro Anastasov Batalov *Department of Internal Diseases, Medical University of Plovdiv, Plovdiv, Bulgaria.ORCID http://orcid.org/0000-0003-1233-5775
Tanya Lyubomirova Sapundzhieva *Department of Internal Diseases, Medical University of Plovdiv, Plovdiv, Bulgaria.ORCID http://orcid.org/0000-0002-2061-6473
Marco Matucci-CerinicDepartment of Experimental and Clinical Medicine, University of Florence, Rheumatology Section, Florence, Italy.ORCID http://orcid.org/0000-0002-9324-3161
Anastas Zgurov BatalovDepartment of Internal Diseases, Medical University of Plovdiv, Plovdiv, Bulgaria.ORCID http://orcid.org/0000-0001-8857-0574
Medical University Plovdiv · BGUniversity of Florence · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Systemic sclerosis (SSc) is a rare autoimmune connective tissue disease characterized by fibrosis of the skin and internal organs, autoimmunity-driven damage and vasculopathy. The current approved disease-modifying treatments have limited efficacy, and treatment is guided toward alleviating organ complications. Thus, there is an unmet need for discovering new effective treatment options. There is recent evidence that the JAK/STAT signaling pathway is markedly activated in SSc patients. To assess the efficacy and safety of tofacitinib (TOF) on skin and musculoskeletal involvement as compared to methotrexate (MTX) in systemic sclerosis (SSc). In this 52-week pilot study, 66 patients with SSc were enrolled: 33 patients received 5 mg of oral TOF twice a day; 33 received 10 mg of MTX weekly. The proportion of dcSSc and lcSSc patients was similar (dcSSc: 42% TOF group and 36% MTX group; lcSSc: 58% TOF group and 64% MTX group). The primary outcome was the change in the modified Rodnan skin score (mRSS). Secondary outcomes included ultrasound (US) skin thickness and musculoskeletal involvement (US10SSc score). Digital ulcers (DUs) and adverse events (AEs) were documented through the treatment. Both groups had similar characteristics and medians on the outcome measures at baseline. At week 52, the TOF median mRSS was significantly lower than the MTX (p < 0.001) with a mean reduction of 13 points versus MTX 2.57. The mean percent improvement in the TOF group was 44% higher than in the MTX group. TOF median US skin thickness was significantly lower than MTX (p < 0.001), with a mean reduction of 0.31 mm versus 0.075 mm in the MTX group. The US10SSc median score was significantly lower in the TOF group (p = 0.002); mean reduction of 10.21 versus 5.27 in the MTX group. Healing of DUs with no new occurrences was observed in the TOF group. There was no significant difference between the groups in the number of AEs from baseline to week 52. TOF showed greater efficacy than MTX in reducing mRSS, skin thickness and musculoskeletal involvement in SSc and a satisfactory safety profile.

Indexed as

AdultFemaleHumansImmunosuppressive AgentsMaleMethotrexateMiddle AgedPilot ProjectsPiperidinesProtein Kinase InhibitorsPyrimidinesScleroderma, SystemicSeverity of Illness IndexSkinSkin UlcerUltrasonographyImmunosuppressive AgentsMethotrexatePiperidinesProtein Kinase InhibitorsPyrimidinestofacitinibJAK/STATSystemic sclerosisTofacitinibUltrasound

Identifiers

PMID34313812
PMCPMC8390399
OpenAlexW3184447129

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.