Successful immunomodulators for the treatment of COVID-19 have opened the pathway for comparative trials

Gallagher, Jason C

doi:10.1016/j.cmi.2022.10.016

Cited by 2 publications

(2 citation statements)

References 7 publications

(7 reference statements)

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“…Given that this was a retrospective study, we were limited in our ability to control for confounding variables; however, the results from the propensity-matched groups correlated with those of the overall cohort. Although retrospective studies have their inherent limitations, it is recognized that current guideline recommendations for use of these agents are made with an overall lack of direct comparisons; therefore, retrospective studies are still important to provide data on comparisons between these agents [ 25 ]. We also did not evaluate laboratory data to further explore the safety and efficacy of these 2 treatment options.…”

Section: Discussionmentioning

confidence: 99%

Comparison of Tocilizumab vs Baricitinib in Clinical Outcomes Among Hospitalized Patients With COVID-19: Experience From a Public Hospital System in New York City

Sunny,

Tran,

Lee

et al. 2023

Open Forum Infectious Diseases

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Background Tocilizumab and baricitinib are immunomodulators that have been repurposed for the treatment of Coronavirus disease 2019 (COVID-19). Whether one medication should be preferred over the other has not been established. Methods This was a multicenter, retrospective cohort study of hospitalized patients with COVID-19 who received either tocilizumab or baricitinib. The primary outcome was improvement in respiratory status (at least 1-point reduction on the respiratory ordinal scale) at day 7 and up to day 28. Secondary outcomes included mortality, disposition, deep vein thrombosis (DVT), pulmonary embolism (PE), or positive blood culture. Outcomes were stratified by baseline respiratory status and variant-predominating time periods. Results were reported for the overall and propensity matched cohorts. Results Overall, 921 patients received tocilizumab and 638 received baricitinib. The propensity matched cohort included 597 patients in each group. At day 7, significantly more patients had improvement in respiratory status in the baricitinib group, in both the overall and propensity-matched cohorts. These improvements were seen in patients requiring supplemental oxygen and noninvasive ventilation/high flow oxygen, but not in patients requiring mechanical ventilation. Favorable outcomes with baricitinib were observed during the Alpha and Omicron time periods. By day 28, there were no differences in the changes in respiratory status for the treatment groups in either cohort. Also, no differences were seen in mortality, disposition, development of DVT/PE, or bloodstream infections. Conclusion Baricitinib treatment was associated with more favorable respiratory improvement at day 7 compared to tocilizumab, but no differences were observed up to day 28.

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Section: Discussionmentioning

confidence: 99%

Comparison of Tocilizumab vs Baricitinib in Clinical Outcomes Among Hospitalized Patients With COVID-19: Experience From a Public Hospital System in New York City

Sunny,

Tran,

Lee

et al. 2023

Open Forum Infectious Diseases

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“…In fact, clinical trials with anti-IL-6, in which selected patients had elevated biomarkers, have shown benefit. However, this benefit did not occur in all patients [ 11 ]. This could have to do with imprecise selection of candidates for treatment based on those biomarkers.…”

mentioning

confidence: 99%

Role of IP-10 to Predict Clinical Progression and Response to IL-6 Blockade With Sarilumab in Early COVID-19 Pneumonia. A Subanalysis of the SARICOR Clinical Trial

Trigo-Rodríguez

Cárcel

Navas

et al. 2023

Open Forum Infectious Diseases

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Background Clinical Trial of Sarilumab in Adults With COVID-19 (SARICOR) showed that patients with COVID-19 pneumonia and increased levels of interleukin (IL)-6 might benefit from blockade of IL6-pathway. However, the benefit from this intervention might not be uniform. In this subanalysis, we sought to determine if other immunoactivation markers, besides IL-6, could identify which subgroup of patients benefit the most of this intervention. Methodology The SARICOR trial was a phase II, open-label, multicentre, controlled (July 2020-March 2021) in which patients were randomized to receive usual care (UC) (control group); UC plus single dose of Sarilumab 200 mg (Sarilumab-200 group) or UC plus single dose of Sarilumab 400 mg (Sarilumab-400 group). Patients who had baseline serum samples for cytokine determination (IL-8, IL-10, MCP-1, IP-10) were included in this secondary analysis. Progression to ARDS according to cytokine levels and treatment received was evaluated. Results 101 (88%) of 115 patients enrolled in the SARICOR trial had serum samples (control group: n=33; Sarilumab-200: n=33; Sarilumab-400 n=35). Among all evaluated biomarkers, IP-10 showed the strongest association with treatment outcome. Patients with IP-10 ≥ 2500 pg/ml treated with Sarilumab-400 had a lower probability of progression (13%) compared to the control group (58%) (HR 0.19; 95% CI: 0.04-0.90; p=0.04). Conversely, patients with IP-10 < 2500 pg/ml did not show these differences. Conclusions IP-10 may predict progression to ARDS in patients with COVID-19 pneumonia and IL-6 levels > 40 pg/ml. Importantly, IP-10 value < 2500 pg/ml might discriminate those individuals who might not benefit of Sarilumab therapy besides high IL-6 levels.

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Successful immunomodulators for the treatment of COVID-19 have opened the pathway for comparative trials

Cited by 2 publications

References 7 publications

Comparison of Tocilizumab vs Baricitinib in Clinical Outcomes Among Hospitalized Patients With COVID-19: Experience From a Public Hospital System in New York City

Comparison of Tocilizumab vs Baricitinib in Clinical Outcomes Among Hospitalized Patients With COVID-19: Experience From a Public Hospital System in New York City

Role of IP-10 to Predict Clinical Progression and Response to IL-6 Blockade With Sarilumab in Early COVID-19 Pneumonia. A Subanalysis of the SARICOR Clinical Trial

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