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Efficacy and safety data based on historical or pre-existing conditions at baseline for patients with active rheumatoid arthritis who were treated with baricitinib
  1. Bernard Combe1,
  2. Alejandro Balsa2,
  3. Piercarlo Sarzi-Puttini3,
  4. Hans-Peter Tony4,
  5. Inmaculada de la Torre5,
  6. Veronica Rogai5,
  7. Frederick Durand5,
  8. Sarah Witt5,
  9. Jinglin Zhong6,
  10. Maxime Dougados7
  1. 1 Rheumatology, CHU Montpellier, Montpellier University, Montpellier, France
  2. 2 Hospital Universitario La Paz, Madrid, Spain
  3. 3 L Sacco University Hospital, Milan, Italy
  4. 4 University Hospital of Würzburg, Würzburg, Germany
  5. 5 Eli Lilly and Company, Indianapolis, Indiana, USA
  6. 6 IQVIA, North Carolina, North Carolina, USA
  7. 7 René Descartes University, Hôpital Cochin, Paris, France
  1. Correspondence to Professor Bernard Combe, Department of Rheumatology, CHU Montpellier and University of Montpellier, Hôpital Lapeyronie, 371 Avenue du Doyen Gaston Giraud, 34295 Montpellier cedex 5, France; b-combe{at}

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Patients with rheumatoid arthritis (RA) have a high prevalence of comorbidities.1 This post-hoc analysis investigated the effect of select comorbidities (depression, osteoporosis, hepatic, cardiovascular or pulmonary disorders) on the efficacy and safety of baricitinib 4 mg once daily in patients with moderate-to-severe active RA and an inadequate response to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs).

Data from the placebo-controlled periods of five baricitinib studies2–6 were pooled for baricitinib 4 mg; data for baricitinib 2 mg were not analysed due to low (n=302) patient numbers. Additional data for all baricitinib-treated patients with a median exposure of 2 years were derived from an ongoing open-label, long-term extension (LTE) study that included patients from phase II and III studies (RA-BEYOND; NCT01885078).7 Efficacy outcomes were evaluated at week 12 (vs placebo). Interaction of comorbidity-by-treatment was analysed using logistic regression or analysis of covariance. Safety observations up to week 16 (vs placebo) and during the LTE were summarised by the Medical Dictionary for Regulatory Activities preferred term.

Data from 1684 patients (803, baricitinib 4 mg; 881, placebo) from the placebo-controlled periods were analysed. The mean (SD) age was 52.7 (12.1) years, with only 38 (2.3%) patients aged ≥75 years; most patients (1506, 89.4%) were receiving background methotrexate, alone or in combination with another csDMARD. The numbers of patients receiving placebo and baricitinib 4 mg combined (with or without each comorbidity, respectively) were 133/1551 for depression, 247/1437 for osteoporosis, 424/1260 for hepatic disorders, 731/953 for cardiovascular disorders, and 166/1518 for pulmonary disorders. Demographic and clinical characteristics within each comorbidity subgroup were similar between patients randomised to baricitinib or placebo.

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