Evidence map›Paper›PMID 34347103›Full record

ArticleInflammatory bowel diseases2022

Safety and Efficacy of Tofacitinib in Combination With Biologic Therapy for Refractory Crohn's Disease.

Scott David Lee, Anand Singla, Jason Harper, Mitra Barahimi, Jeffrey Jacobs, Kendra J Kamp, Kindra Dawn Clark-Snustad

Registry-linked trialOpen access · greenAbstract read
In one paragraph

Article in Inflammatory bowel diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06520397 (Evaluation of the Efficacy and Safety of Dual-targeted Therapy With Upadacitinib and Ustekinumab Versus Intensified Ustekinumab Therapy in Crohn's Disease Patients With an Insufficient Response to Standard-dose Ustekinumab), which is not on this map. Cited by 21 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 3 pooled it
3.1field-weighted citation impact, top 8% 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.

NCT06520397 phase4recruitingnot on this mapstarted 2024, after this paper: background citation

Evaluation of the Efficacy and Safety of Dual-targeted Therapy With Upadacitinib and Ustekinumab Versus Intensified Ustekinumab Therapy in Crohn's Disease Patients With an Insufficient Response to Standard-dose Ustekinumab: A Randomized Controlled Trial

TypeinterventionalSponsorSixth Affiliated Hospital, Sun Yat-sen UniversityRan2024 to 2027Enrolled214ConditionsCrohn DiseaseArmsUstekinumab and Upadacitinib, Ustekinumab
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 3 syntheses or guidelines pooled it, 31 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Article
  5. Advanced Combination Therapy in Inflammatory Bowel Disease: What Does the Future Hold?BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026
    Review
  6. [Advanced Combination Therapy in Inflammatory Bowel Disease].The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2026
    Review
  7. Review
  8. Review
  9. Review
  10. Article
  11. Article
  12. Review
  13. Article
  14. Review
  15. Refractory Crohn's Disease: Perspectives, Unmet Needs and Innovations.Clinical and experimental gastroenterology · 2024
    Review
  16. Review
  17. Precision medicine in inflammatory bowel disease.Precision clinical medicine · 2023
    Review
  18. Article
  19. Review
  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 1 country.

Scott David LeeUniversity of Washington, Division of Gastroenterology, Seattle, Washington, USA.ORCID 0000-0001-8936-8052
Anand SinglaUniversity of Washington, Division of Gastroenterology, Seattle, Washington, USA.
Jason HarperUniversity of Washington, Division of Gastroenterology, Seattle, Washington, USA.
Mitra BarahimiUniversity of Washington, Division of Gastroenterology, Seattle, Washington, USA.
Jeffrey JacobsUniversity of Washington, Division of Gastroenterology, Seattle, Washington, USA.
Kendra J KampUniversity of Washington, Division of Gastroenterology, Seattle, Washington, USA.
Kindra Dawn Clark-SnustadUniversity of Washington, Division of Gastroenterology, Seattle, Washington, USA.
University of Washington · US

Funding

UNIVERSITY OF WASHINGTON GI TRAINING GRANTT32DK007742 · NIDDK · UNIVERSITY OF WASHINGTON · PI GRADY, WILLIAM MALLORY · 1996 to 2022
$4.7M
NIDDK NIH HHS T32 DK007742
6 · The paper itself

Abstract

backgroundThe majority of patients with Crohn's disease (CD) will not achieve endoscopic remission on current therapy. Addition of tofacitinib to biologics may improve remission rates.

methodsWe retrospectively assessed safety and clinical and endoscopic effectiveness of off-label tofacitinib and biologics for CD.

resultsWe identified 19 patients treated with tofacitinib and a biologic for refractory CD between 2017 and 2019. Tofacitinib was added for luminal disease on colonoscopy (n = 13), luminal disease on capsule (n = 3), and pyoderma gangrenosum (n = 3). The mean age was 41.2 years (28-62), mean disease was duration 16.9 years (6-36), and prior exposure to biologics was a median of 4 (1-6). Mean treatment duration was 9.6 months (SD, 3.3). Adverse events (AEs) were reported in 36.8% of patients, most commonly minor infection or CD flare, and no patients had a serious AE; 80.0% (n = 8) achieved clinical response, and 60.0% (n = 6) achieved clinical remission based on Harvey-Bradshaw Index. Endoscopic improvement occurred in 54.5% (n = 6), endoscopic remission in 18.2% (n = 2), and endoscopic healing in 18.2% (n = 2) of patients. Mean Simple Endoscopic Score in CD significantly improved from 13.6 ± 5.2 to 6.5 ± 4.0 after treatment (P < .01).

conclusionsIn patients treated with tofacitinib in combination with a biologic, no new safety signals were observed. Combination tofacitinib and a biologic was effective in achieving clinical and endoscopic improvement in some patients with severe, refractory CD, although a larger sample size is needed to further assess the efficacy and long-term safety of this treatment strategy.

Indexed as

Crohn DiseaseAdultBiological TherapyHumansPiperidinesPyrimidinesRemission InductionRetrospective StudiesPiperidinesPyrimidinestofacitinibbiologicCrohn’s diseaserefractorysmall moleculetofacitinib

Identifiers

PMID34347103
PMCPMC8804506
OpenAlexW3192918953

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.