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Benefits of anakinra versus TNF inhibitors in rheumatoid arthritis and type 2 diabetes: long-term findings from participants furtherly followed-up in the TRACK study, a multicentre, open-label, randomised, controlled trial


1, 2, 3, 4

 

  1. Rheumatology, Department of Biotechnological and Applied Clinical Sciences, University of L’Aquila, Italy. piero.ruscitti@univaq.it
  2. Rheumatology, Department of Biotechnological and Applied Clinical Sciences, University of L’Aquila, Italy.
  3. Rheumatology, Department of Biotechnological and Applied Clinical Sciences, University of L’Aquila, Italy.
  4. Rheumatology and Immunology Unit, Department of Medicine, University of Rome ‘Campus Biomedico’, Rome, Italy.

on behalf of the TRACK study group

CER13963
2021 Vol.39, N°2
PI 0403, PF 0406
Brief Paper

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PMID: 33666156 [PubMed]

Received: 23/08/2020
Accepted : 25/01/2021
In Press: 03/03/2021
Published: 09/04/2021

Abstract

OBJECTIVES:
Interleukin (IL)-1β is considered a shared pathogenic mediator between rheumatoid arthritis (RA) and type 2 diabetes (T2D). In the TRACK study, participants with both diseases were randomised to an IL-1 inhibitor, anakinra, or a TNF inhibitor (TNFi). After 6 months, anakinra induced a such of improvement on metabolic and inflammatory parameters, leading to a premature stoppage of the study. Thus, we aimed to assess how long IL-1 inhibition benefits lasted.
METHODS:
Since the TRACK was prematurely discontinued for “early benefit”, we furtherly followed-up the enrolled participants to assess how long persisted the improvement of glycated haemoglobin (HbA1c%) and of RA disease activity.
RESULTS:
After a mean follow-up of 18 months (15 participants in anakinra-group and 14 in TNFi-group), RA clinical response was retained in both groups (DAS28: 2.59±1.01 vs. 2.88±0.91; p=0.109). Concomitant glucocorticoids were reduced in both groups (2.01±0.71 vs. 3.01±0.87 mg/die; p=0.124), but a larger percentage of anakinra-treated participants discontinued such drugs (53.3% vs. 28.6%; p=0.004). There was no difference between anakinra and TNFi for HbA1c% (6.60±0.52 vs. 6.79±0.43; p=0.291), but a reduction of anti-diabetic drugs was observed in anakinra-treated participants (53.3% vs. 7.1%; p=0.008) whereas an increase of anti-diabetic therapies was needed in TNFi-treated ones. Significant correlations were also observed among HbA1c% with DAS28 and with C-reactive protein. Analysing the safety profile, only minor side effects were recorded.
CONCLUSIONS:
Data deriving from the long-term extension of participants with RA and T2D, enrolled in the TRACK study, could suggest that the benefits of IL-1 inhibition on metabolic and inflammatory parameters could last longer than first 6 months of follow-up, but further studies are needed to confirm these findings.

Rheumatology Article