Expert opinion on biological therapy
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Expert Opin Biol Ther · May 2021
Randomized Controlled Trial Multicenter StudyA two-arm, randomized, controlled, multi-centric, open-label phase-2 study to evaluate the efficacy and safety of Itolizumab in moderate to severe ARDS patients due to COVID-19.
Objective: Efficacy and safety of Itolizumab, an immunomodulatory mAb, in treating moderate-to-severe acute respiratory distress syndrome (ARDS) due to cytokine release in COVID-19 patients was evaluated in a multi-centric, open-label, two-arm, controlled, randomized, phase-2 study. Methods: Patients were randomized (2:1) to Arm-A (best supportive care [BSC]+Itolizumab) and Arm-B (BSC). Primary outcome of interest was reduction in mortality 30-days after enrollment. ⋯ At end of study, more patients in Arm-A had improved SpO2 without increasing FiO2 (p = 0.0296), improved PaO2 (p = 0.0296), and reduction in IL-6 (43 vs 212 pg/ml; p = 0.0296) and tumor necrotic factor-α (9 vs 39 pg/ml; p = 0.0253) levels. Transient lymphopenia (Arm-A: 11 patients) and infusion reactions (7 patients) were commonly reported treatment-related safety events. Conclusion: Itolizumab is a promising, safe and effective immunomodulatory therapy for treatment of ARDS due to cytokine release in COVID-19 patients, with survival and recovery-benefit.
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Expert Opin Biol Ther · May 2021
Dupilumab for the treatment of chronic rhinosinusitis with nasal polyposis.
Introduction: Chronic rhinosinusitis with nasal polyps (CRSwNP) affects 1-2.5% of the population and is associated with significant adverse effects on quality of life (QoL). CRSwNP is strongly correlated with (late onset) asthma with 30-70% of the CRSwNP patients having asthma. Health-care spending in rhinosinusitis is high, especially because of indirect costs. ⋯ Treatment with dupilumab results in a significant improvement of QoL (measured as SNOT-22), rhinosinusitis disease severity, symptoms of rhinosinusitis, and especially sense of smell, nasal polyp score, Lund-Mackay CT score, and asthma outcomes (ACQ5 and FEV1) compared to placebo. Expert opinion: At this moment, the high cost of the treatment requires careful patient selection and within the EUFOREA and EPOS2020 context, experts have tried to give guidance based on today's data. We now need trials evaluating which patients benefit most from treatment with biologicals and in which patients the treatment is cost-effective.