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Abstract Number: 2360

Incidence Of Diabetes and Effect Of Etanercept and Adalimumab On HbA1c Over 1 Year: Data From a Randomised Trial In Patients With Rheumatoid Arthritis

Paola de Pablo1, Fiona M. Maggs2, David Carruthers3, Abdul A. Faizal4, Mark T. Pugh5 and Paresh Jobanputra6, 1Rheumatology, University of Birmingham Research Laboratories, Queen Elizabeth Hospital, University of Birmingham, College of Medical & Dental Sciences, Queen Elizabeth Hospital Birmingham, UK, Birmingham, United Kingdom, 2Department of Rheumatology, Queen Elizabeth Hospital Birmingham, UK, Birmingham, United Kingdom, 3Department of Rheumatology, Sandwell and West Birmingham Hospitals NHS Trust, UK, Birmingham, United Kingdom, 4Department of Rheumatology, Solihull Hospital, Heart of England NHS Foundation Trust, UK, Solihull, United Kingdom, 5Department of Rheumatology, Saint Mary's Hospital, UK, Isle of Wight, United Kingdom, 6Department of Rheumatology, Queen Elizabeth Hospital Birmingham, UK., Birmingham, United Kingdom

Meeting: 2013 ACR/ARHP Annual Meeting

Keywords: Adalimumab, Biologic drugs, Diabetes, etanercept and rheumatoid arthritis (RA)

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Session Information

Session Title: Rheumatoid Arthritis Treatment - Small Molecules, Biologics and Gene Therapy III

Session Type: Abstract Submissions (ACR)

Background/Purpose:  Inflammation such as that which occurs in rheumatoid arthritis (RA) is associated with insulin resistance and risk of diabetes mellitus (DM). Some DMARDs including TNF inhibitors (TNFi) may improve insulin resistance and DM risk. However, it is unknown whether TNFi improve HbA1c in patients with RA with or without DM. Data on HbA1c was collected in a randomised trial comparing drug continuation rates for etanercept and adalimumab (BMJ Open 2012;2:e001395). We estimated the incidence of DM from this data and studied the impact of therapy on HbA1c.

Methods:  Participants with active RA, who had previously failed to respond to 2 non-biologic DMARDs including methotrexate, were randomised to etanercept or adalimumab and followed 3-monthly over 1 year. Data collected included co-morbidities, clinical and laboratory parameters, and medications at each visit. The primary endpoint was newly recorded diabetes defined as HbA1c >48mmol/mol at any time point. Predictors of HbA1c and HbA1c change were determined with univariate and multivariate analyses. 

Results:  Of the 125 patients with active RA randomised to etanercept or adalimumab, 6 (4.8%) were known diabetics and 88% were RF/ACPA positive. Of the 119 without DM, 7 (5.9%) were diagnosed with DM (HbA1c >48mmol/mol) at baseline. 73 participants (73% female) completed  1 year of TNFi therapy: mean age 54 yrs (SD±12), mean BMI 27.8, mean HbA1c 38 mmol/mol. Of these, 4 (5%) patients had DM at baseline. A majority of patients were on methotrexate (67%) and 33% on prednisolone. Baseline characteristics were similar for patients’ allocated to adalimumab (52%) or etanercept (48%), except more patients on etanercept were on prednisolone (49% vs. 18%; p=0.006); and more patients on adalimumab were on hydroxycloroquine (24% vs. 3%; p=0.01).  After excluding those with known DM at baseline, among those completing one year of TNFi (n=69), 3 (4.4%) patients had an HbA1c >48 mmol/mol at baseline, 1 (1.5%) at 3 months, 1 (1.5%) at 6 months, and 2 (2.9%) at 12 months of follow-up. 2 (3%) cases had a HbA1c >48 mmol/mol at 2 follow-up visits. The incidence of DM was 29 new cases per 1000-person years (95% CI 3.51-105).  Those on adalimumab tended to have higher levels of HbA1c than those on etanercept but the differences between groups at each time point were non-significant. However, there was a significant rise in HbA1c levels after 1 year of adalimumab therapy (37.27 mmol/mol and 38.80 mmol/mol; p=0.01). Etanercept therapy did not influence HbA1c levels over time.

Conclusion:  Incidence of diabetes in patients entering a randomised trial of etanercept and adalimumab was considerably higher than other recent data. Treatment with a TNFi did not improve HbA1c levels with either agent in diabetics and non-diabetics. After excluding those with diabetes, those on adalimumab had higher mean HbA1c levels after 1 year of therapy.


Disclosure:

P. de Pablo,
None;

F. M. Maggs,
None;

D. Carruthers,
None;

A. A. Faizal,
None;

M. T. Pugh,
None;

P. Jobanputra,
None.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/incidence-of-diabetes-and-effect-of-etanercept-and-adalimumab-on-hba1c-over-1-year-data-from-a-randomised-trial-in-patients-with-rheumatoid-arthritis/

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