Tocilizumab versus baricitinib in hospitalized patients with severe COVID-19: an open label, randomized controlled trial

Karampitsakos, Theodoros; Papaioannou, Ourania; Tsiri, Panagiota; Katsaras, Matthaios; Katsimpris, Andreas; Kalogeropoulos, Andreas P.; Malakounidou, Elli; Zarkadi, Eirini; Tsirikos, Georgios; Georgiopoulou, Vasiliki V.; Sotiropoulou, Vasilina; Koulousousa, Electra; Chourpiliadi, Charikleia; Matsioulas, Apostolos; Lagadinou, Maria; Sampsonas, Fotios; Akinosoglou, Karolina; Marangos, Markos; Τzouvelekis, Αrgyris

doi:10.1016/j.cmi.2022.10.015

Cited by 29 publications

(18 citation statements)

References 29 publications

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“…8 Although a benefit has been seen with each of these agents in treating critically ill patients with COVID-19 pneumonia, to date, only smaller observational studies and one randomized controlled trial (RCT) have been published comparing the safety and efficacy of these two agents to each other. 25,[30][31][32][33] These trials have disparate results with most finding no difference between therapies.…”

Section: Discussionmentioning

confidence: 99%

“…Due to this, baricitinib use increased in critically ill patients as an alternative immunomodulator to tocilizumab. Despite guideline recommendations for use of either tocilizumab or baricitinib in severely ill patients, there are limited randomized controlled head‐to‐head trials comparing the clinical efficacy and safety profiles of tocilizumab and baricitinib 1,2,25 . To address this knowledge gap, this study sought to compare efficacy and safety outcomes of tocilizumab and baricitinib in a critically ill patient population with COVID‐19.…”

Section: Introductionmentioning

confidence: 99%

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Baricitinib versus tocilizumab in critically ill COVID‐19 patients: A retrospective cohort study

Conroy,

Bauer,

Pallotta

et al. 2023

Pharmacotherapy

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BackgroundTocilizumab and baricitinib improve outcomes in severely ill patients with coronavirus disease 2019 (COVID‐19), however, comparative analyses of clinical outcomes related to these agents is lacking. A tocilizumab national shortage shifted treatment to baricitinib in critically ill patients, allowing for an outcome comparison in a similar population. The purpose of this study is to compare clinical outcomes in critically ill COVID‐19 patients who received tocilizumab and those who received baricitinib.MethodsThis retrospective, multicenter cohort study of adult patients with severe COVID‐19 compared the use of tocilizumab, before its shortage, to baricitinib use during the shortage. Both drugs were formulary restricted at the study sites with identical patient criteria for use. The primary outcome was World Health Organization Clinical Progression Scale (WHO‐CPS) score at day 14. Secondary outcomes included WHO‐CPS score at day 7. Generalized estimating equation models were utilized, accounting for clustering by hospital and known confounders, to estimate the proportional odds of the ordinal WHO‐CPS score at day 14.ResultsIn total, 507 patients were included; 217 received tocilizumab and 290 received baricitinib. Over 96% of patients required ICU admission and 98% received concomitant dexamethasone. Tocilizumab recipients had higher (worse) baseline WHO‐CPS scores. After adjustment, tocilizumab use was associated with higher odds of a worse day 14 WHO‐CPS score compared with baricitinib (adjusted odds ratio [OR] 1.65 [95% confidence interval (CI) 1.10‐2.48]). Similarly, after adjustment, tocilizumab use was associated with higher odds of a worse day 7 WHO‐CPS score (adjusted OR 1.65 [95% CI 1.22‐2.24]).ConclusionsBaricitinib use was associated with better WHO‐CPS scores at day 14 and day 7 compared with tocilizumab in a cohort of critically ill patients with COVID‐19. The odds of having a one unit increase in WHO‐CPS score at day 14 was 71% higher with tocilizumab than baricitinib. No difference in mortality or adverse effects was noted.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Baricitinib versus tocilizumab in critically ill COVID‐19 patients: A retrospective cohort study

Conroy,

Bauer,

Pallotta

et al. 2023

Pharmacotherapy

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“…The role of immunity in acute and chronic lung injury has been now established (Sweis et al) (1,2). With regards to interstitial lung diseases (ILDs), a possible association with immunity was first reported almost 50 years ago.…”

Section: Editorial On the Research Topic Immune-mediated Lung Injurymentioning

confidence: 99%

Editorial: Immune-mediated lung injury

Karampitsakos,

Spagnolo,

Tzouvelekis

2023

Front. Med.

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“… 3 Nevertheless, there has been a lack of comparative evidence between the use of tocilizumab and baricitinib in patients with COVID-19. To date, there was only 1 head-to-head randomized controlled trial 4 that investigated the comparative clinical outcomes between baricitinib and tocilizumab in patients with severe COVID-19, and it was reported that baricitinib was noninferior to tocilizumab for the primary composite outcome of mechanical ventilation or death by day 28 (hazard ratio = 0.83; 95% confidence interval = 0.56 to 1.21). Therefore, the retrospective cohort study performed and reported by Reid et al 1 adds to the comparative evidence between the use of tocilizumab and baricitinib in this population of patients.…”

mentioning

confidence: 99%