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Change in the discontinuation pattern of tumour necrosis factor antagonists in rheumatoid arthritis over 10 years: data from the Spanish registry BIOBADASER 2.0
  1. Juan J Gómez-Reino1,2,
  2. Carlos Rodríguez-Lozano3,
  3. Cristina Campos-Fernández4,
  4. María Montoro5,
  5. Miguel Ángel Descalzo6,
  6. Loreto Carmona1,7 on behalf of the BIOBADASER 2.0 Study Group*
  1. 1Rheumatology Department, Hospital Clínico Universitario, Santiago de Compostela, Spain
  2. 2Department of Medicine, Medical School, Universidad de Santiago de Compostela, Santiago de Compostela, Spain
  3. 3Rheumatology Department, Hospital Universitario de Gran Canaria Dr Negrín, Las Palmas, Gran Canaria, Spain
  4. 4Rheumatology Department, Hospital General Universitario de Valencia, Valencia, Spain
  5. 5Rheumatology Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain
  6. 6Research Unit, Sociedad Española de Reumatología, Madrid, Spain
  7. 7Health Sciences School, Universidad Camilo José Cela, Madrid, Spain
  1. Correspondence to Juan J Gómez-Reino, Rheumatology and Department of Medicine, Hospital Clínico Universitario, Universidad de Santiago de Compostela Medical School, A Choupana s/n, 15706, Santiago de Compostela, Spain; juan.gomez-reino.carnota{at}


Objective To investigate in rheumatoid arthritis (RA) the rate and reason of discontinuation of tumour necrosis factor (TNF) antagonists over the past decade.

Methods RA patients in BIOBADASER 2.0 were stratified according to the start date of their first TNF antagonist into 2000–3, 2004–6 and 2007–9 interval years. Cumulative incidence function of discontinuation for inefficacy or toxicity was estimated with the alternative reason as competing risk. Competing risks regression models were used to measure the association of study groups with covariates and reasons for discontinuation. Association is expressed as subhazard ratios (SHR).

Results 2907 RA patients were included in the study. Competing risk regression for inefficacy shows larger SHR for patients starting treatment in 2004–6 (SHR 2.57; 95% CI 1.55 to 4.25) and 2007–9 (SHR 3.4; 95% CI 2.08 to 5.55) than for those starting in 2000–3, after adjusting for TNF antagonists, clinical activity and concomitant treatment. Competing risk regression analysis for adverse events revealed no differences across the three time intervals.

Conclusions In RA, the discontinuation rate of TNF antagonists in the first year of treatment is higher more recently than a decade ago, inefficacy being the main reason for the increased rate. The rate of discontinuation for adverse events has remained stable.

Statistics from


  • * See end of paper for list of BIOBADASER 2.0 Study Group participants.

  • Funding BIOBADASER is supported by the Spanish Society and the Spanish Agency of Medicines and Healthcare Products. Grants in approximately equal amounts (all under €25 000/year) from Roche, Abbott, BMS, MSD and Pfizer contribute to the support of the registry. This work was partly supported by the RETICS Program, RD08/0075 (RIER) from Instituto de Salud Carlos III (ISCIII).

  • Competing interests JJGR is on the advisory boards of Schering-Plough, UCB, Wyeth, Pfizer, MSD, Bristol Meyers Squibb and Roche, and has received lecture fees from Abbott Laboratories, Wyeth, MSD, Roche, Bristol Meyers Squibb and Schering-Plough. LC has received lecture fees from Abbott Laboratories and Pfizer. CRL has received lecture fees from Abbott, Bristol Myers Squibb and Wyeth. CCF, MM and MAD have no conflicts of interest.

  • Patient consent Obtained.

  • Ethics approval This study was approved by the Ethics Review Committee of the Hospital Ramón y Cajal, Madrid, Spain.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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