Evidence map›Paper›PMID 37730835›Full record

ArticleScientific reports2023

Tapering and discontinuation of glucocorticoids in patients with rheumatoid arthritis treated with tofacitinib.

Francesca Romana Spinelli, Cristina Garufi, Silvia Mancuso, Fulvia Ceccarelli, Simona Truglia, Fabrizio Conti

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Scientific reports, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06172361 (Efficacy and Safety of Induction and Tapering Therapy With Tofacitinib and Glucocorticoid in Patients With Polymyalgia Rheumatica), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
3.2field-weighted citation impact, top 7% 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.

NCT06172361 phase3recruitingnot on this mapstarted 2024, after this paper: background citation

Efficacy and Safety of Induction and Tapering Therapy With Tofacitinib and Glucocorticoid in Patients With Polymyalgia Rheumatica (ITTG PMR): An Open-label 52-week Randomized Controlled Trial

TypeinterventionalSponsorZhejiang UniversityRan2024 to 2026Enrolled98ConditionsPolymyalgia RheumaticaArmsPrednisone+Tofacitinib, Prednisone
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 13 citations in OpenAlex.

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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

6 authors at 1 institution in 1 country.

Francesca Romana Spinelli *Dipartimento di Scienze Cliniche Internistiche, Anestesiologiche e Cardiovascolari - Rheumatology Unit, Sapienza Università di Roma, Rome, Italy. francescaromana.spinelli@uniroma1.it.
Cristina Garufi *Dipartimento di Scienze Cliniche Internistiche, Anestesiologiche e Cardiovascolari - Rheumatology Unit, Sapienza Università di Roma, Rome, Italy.
Silvia MancusoDipartimento di Scienze Cliniche Internistiche, Anestesiologiche e Cardiovascolari - Rheumatology Unit, Sapienza Università di Roma, Rome, Italy.
Fulvia CeccarelliDipartimento di Scienze Cliniche Internistiche, Anestesiologiche e Cardiovascolari - Rheumatology Unit, Sapienza Università di Roma, Rome, Italy.
Simona TrugliaDipartimento di Scienze Cliniche Internistiche, Anestesiologiche e Cardiovascolari - Rheumatology Unit, Sapienza Università di Roma, Rome, Italy.
Fabrizio ContiDipartimento di Scienze Cliniche Internistiche, Anestesiologiche e Cardiovascolari - Rheumatology Unit, Sapienza Università di Roma, Rome, Italy.
Sapienza University of Rome · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Although the rapid onset of effect of glucocorticoids (GCs) allows rapid control of rheumatoid arthritis (RA) symptoms, their chronic use may be associated with several adverse events. The 2022 update of EUALR recommendations for the management of patients with RA suggests to reduce and discontinue oral GCs as quickly as possible. Considering GCs as a "bridging therapy" to promptly reduce symptoms and control inflammation, fast-acting drugs such as tofacitinib could allow faster and safer tapering of GCs. The purpose of this pilot study was to evaluate the steroid-sparing effect of adding tofacitinib in patients with RA inadequately responsive to methotrexate taking concomitant GCs. In this open-label pilot study, we enrolled patients with moderate to severe RA on a stable dose of prednisone (5-12.5 mg/day) who started treatment with tofacitinib. After 1 month, in patients who achieved at least a moderate EULAR response (decrease of > 1.2 in DAS28_CRP), GCs was tapered according to a predetermined schedule until complete discontinuation at week 12. Disease activity was assessed after 4, 12, 24 and 48 weeks of treatment. The primary endpoint was the percentage of patients discontinuing GCs after 12 weeks of tofacitinib treatment. We enrolled 30 patients (26 F: 4 M, mean age 60 ± 13 years, mean disease duration 13.2 ± 7.8 years). The primary endpoint was achieved: 9 patients (30%) discontinued GCs at week-12. At week-24, other 12 patients (46%) withdrew GCs. The median prednisone dose decreased from 5 mg/day (interquartile range 5-10 mg) to 2.5 (0-5) mg/day at week 12 and 48 (p < 0.00001 vs baseline). At week 48, 12 out of 30 patients (40%) had discontinued prednisone. The percentage of patients achieving remission or low disease activity increased throughout the follow-up without any difference between patients who discontinued or not the GC. In this cohort of long-standing RA patients treated with tofacitinib, the discontinuation of glucocorticoids was achievable in up to 30% of patients. These results should encourage rheumatologists to consider GCs tapering and discontinuation of GCs, as suggested by the 2022 EULAR recommendations, an achievable goal.

Indexed as

Arthritis, RheumatoidGlucocorticoidsAgedHumansMiddle AgedPilot ProjectsPiperidinesPrednisonePyrimidinesGlucocorticoidsPiperidinesPrednisonePyrimidinestofacitinib

Identifiers

PMID37730835
PMCPMC10511736
OpenAlexW4386890163

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.