Background/Purpose: Growing evidence from RCTs and real-life experiences has highlighted important similarities between severe COVID19 and rapidly progressive interstitial lung diseases (RP-ILD) occurring in connective tissue diseases (CTDs). These data supported the use of anti-rheumatic drugs, baricitinib and glucocorticoids, for the treatment of COVID19 pneumonia. Aim of the study was to compare mortality and inflammatory response in critically-ill COVID19 patients treated with either a “rheumatological approach” based on baricitinib plus pulse steroids (BPS) or with a “conventional approach” (Standard of Care, SoC).

Methods: In this retrospective study, we enrolled patients admitted to the Intensive Care Unit (ICU) with CT-proven SARS-CoV2 pneumonia, from September 2020 to January 2022. Demographic, laboratory, and clinical data were collected at the admission and after one week of treatment. SoC included dexamethasone 6 to 8 mg daily plus remdesivir (+/- antibiotics and hydroxychloroquine); BPS approach was based on baricitinib 4 mg daily for 10-14 days plus 6-methylprednisolone pulses (250-500 mg) for three consecutive days followed by rapid tapering. Intra-ICU mortality rate and change of inflammatory biomarkers after one week of treatment were assessed.

Results: We enrolled a total of 246 consecutive patients with SARS-CoV2 pneumonia (male 65.4%, mean age 65.3 ± 11 years); 104/246 (male 67.3%, mean age 66.8 ± 10.4years) were treated with SoC and 142/246 (male 64.1%, mean age 64 ± 11.3 years) with BPS.

At admission in ICU, mean latency from the first symptom of SARS-CoV2 infection was about 10 days. All patients presented laboratory biomarkers’ alterations suggestive of hyper-inflammatory response (CRP 10.8 ± 7.9 mg/dL, ferritin 1224 ± 1018 µg/L, fibrinogen 573 ± 165 mg/dL, LDH 385 ± 153 U/L) and severe respiratory failure, requiring non-invasive or invasive ventilatory support. Lung-CT pattern showed multiple and diffuse areas of ground glass opacities, septal thickening, and/or consolidation.

No statistically significant differences were found between SoC and BPS groups in terms of demographic, laboratory, and clinical features at enrolment.

64/246 (26.1%) patients died during ICU hospitalization. Mortality rate in the BPS group (22/142, 15.5%) resulted significantly lower compared to that in the SoC group (42/104, 40.4%) (p< 0.001) Furthermore, compared to SoC, patients in the BPS group displayed significantly lower levels of CRP (2.0 ± 2.7 vs 6.1 ± 7.3, p< 0.001), fibrinogen (358 ± 118 vs 453 ± 172, p< 0.001), and ferritin (888.3 ± 619.3 vs 1075 ± 857, p< 0.05) after one week of treatment. Higher ferritin level after one week of treatment resulted strongly associated with mortality (p< 0.001).

Conclusion: This study describes the largest real-life cohort of COVID19 patients treated with a combination of pulse steroids and baricitinib in an ICU setting. A “rheumatological approach” seems to be associated with a significant reduction of mortality paralleled by a prompt reduction of inflammatory biomarkers. Our real-life experience confirms the latest evidences on the pathogenetic mechanisms of severe COVID19 phenotype which is not distinguishable from CTD-associated RP-ILD.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/combination-treatment-with-baricitinib-and-pulse-steroids-in-severe-covid19-a/