ANAKINRA PLUS STANDARD OF CARE FOR THE REDUCTION OF HYPERINFLAMMATION AND RESPIRATORY DISTRESS IN PATIENTS WITH SARS-COV-2 INFECTION: A MULTICENTRE, RANDOMISED, OPEN-LABEL PHASE 2/3 TRIAL (ANA-COVID-GEAS STUDY)

P. Fanlo, B. Gracia Tello, E. Fonseca, J. Álvarez Troncoso, A. González, S. Prieto-González, M. Freire, A. Argibay, L. Pallares Ferreres, J. A. Todoli, M. Perez Conesa, S. Bujan Rivas, B. IbañezHospital Universitario de Navarra, Internal Medicine, Pamplona, Spain Hospital Universitario Clínico Lozano Blesa, Internal Medicine, Zaragoza, Spain Hospital de Cabueñes, Internal Medicine, Cabueñes, Spain Hospital La Paz, Internal Medicine, Madrid, Spain Hospital Ramón y Cajal, Internal Medicine, Madrid, Spain Hospital Clinic, Internal Medicine, Barcelona, Spain Complejo Hospitalario de Santiago, Internal Medicine, Santiago de Compostela, Spain Complejo Hospitalario de Vigo, Internal Medicine, Vigo, Spain Hospital Son Espases, Internal Medicine, Palma de Mallorca, Spain Hospital Universitario La Fe, Internal Medicine, Valencia, Spain Hospital Universitario Miguel Servet, Internal Medicine, Zaragoza, Spain Hospital Vall d´Hebron, Internal Medicine, Barcelona, Spain Hospital Universitario de Navarra, Navarrabiomed, Pamplona, Spain  Background COVID-19 pneumonia is often associated with hyperinflammation. The efficacy and security of anakinra in patients with severe COVID-19 pneumonia and hyperinflammation are still unclear. Objectives The primary endpoint was the proportion of patients not requiring mechanical ventilation up to 15 days after treatment initiation, assessed on an intention-to-treat-basis. Methods A multicentre, randomised, open-label, two-arm phase 2/3 trial was conducted at 12 hospitals in Spain. Adult patients with severe pneumonia were randomly assigned (1:1) to receive either usual standard of care plus anakinra (anakinra group) or usual standard of care alone (SoC group). Anakinra was given at a dose of 100 mg four times a day intravenously. The trial is registered with ClinicalTrials.gov; NCT04443881. Results Between 8 May 2020 and 1 March 2021, a total of 179 patients were randomly assigned to the anakinra group (n=92) or to the SoC group (n=87). The proportion of patients not requiring mechanical ventilation up to day 15 was not significantly different between groups (77.1% for Anakinra group vs 85.9% for SoC group, risk ratio 0·90 [95% CI 0·77–1·04]; p=0·16). Anakinra did not result in any difference in time to mechanical ventilation (HR 1·72 [95% CI 0·82-3·62], p=0·14). There was no significant difference between groups in the proportion of patients not requiring invasive mechanical ventilation up to day 15 (RR 0·99 [95% CI 0·88–1·11]; p=1·00). Conclusion Anakinra did not prevent the need for mechanical ventilation or reduce mortality risk compared with standard of care alone in hospitalised patients with severe COVID-19 References Guan WJ, Ni ZY, Hu Y, et al. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med 2020; 382(18): 1708-20. Huang C, Wang Y, Li X, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet 2020; 395(10223): 497-506. Acknowledgements: NIL. Disclosure of Interests None Declared. Keywords: COVID, bDMARD, Randomized control trial DOI: 10.1136/annrheumdis-2023-eular.6414Citation: , volume 82, supplement 1, year 2023, page 57Session: COVID 19: A pandemic with a long tail (Oral Presentations)