Dupilumab Reduces Oral Corticosteroid Use in Patients With Corticosteroid-Dependent Severe Asthma

Abstract

BackgroundMany patients with severe asthma require chronic corticosteroid treatment to maintain asthma control.Research QuestionAre the reduction in oral corticosteroid (OCS) use and the clinical efficacy observed with dupilumab treatment maintained long-term in patients with severe OCS-dependent asthma?Study Design and MethodsThe LIBERTY ASTHMA TRAVERSE study (ClinicalTrials.gov identifier: NCT02134028) was a multinational, multicenter, single-arm, open-label extension study in patients ≥ 12 years of age with asthma who participated in previous dupilumab studies. Treatment consisted of dupilumab 300 mg every 2 weeks for up to 96 weeks. In this analysis, we present the data from patients who initially enrolled in the LIBERTY ASTHMA VENTURE study (ClinicalTrials.gov identifier: NCT02528214), a 24-week placebo-controlled study of dupilumab in patients with OCS-dependent severe asthma, and continued in the TRAVERSE study. The subgroups analyzed were: those who received dupilumab in both (dupilumab/dupilumab group) and those who received placebo in the VENTURE study and dupilumab in the TRAVERSE study (placebo/dupilumab group). Outcomes included OCS use, exacerbation rates, and measures of lung function and asthma control.ResultsNinety patients treated with dupilumab/dupilumab and 97 patients treated with placebo/dupilumab in the VENTURE study were enrolled and treated in the TRAVERSE study, with a mean OCS dosage of 11.0 mg/d (dupilumab) and 11.6 mg/d (placebo) at VENTURE study baseline. At TRAVERSE week 0, the mean daily OCS dosage was 3.1 mg/d and 6.4 mg/d (percentage decrease from the VENTURE study baseline, 68.8% and 41.3%) for the dupilumab/dupilumab group and placebo/dupilumab group, respectively, and decreased to 2.2 mg/d and 4.9 mg/d (78.3% and 53.4%) at week 48 and to 1.2 mg/d and 3.0 mg/d (89.3% and 74.4%) at week 96, respectively. Exacerbation rates were low during the TRAVERSE study. Further improvements from the VENTURE to TRAVERSE studies also were seen in FEV1 and 5-item Asthma Control Questionnaire scores. Safety findings were consistent with the known dupilumab safety profile.InterpretationIn the open-label TRAVERSE study, dupilumab demonstrated the ability to sustain the OCS dosage reduction from the parent OCS-sparing study, while maintaining a low exacerbation rate and improved lung function.Trial RegistryClinicalTrials.gov; Nos.: NCT02134028 (TRAVERSE) and NCT02528214 (VENTURE); URL: www.clinicaltrials.gov Many patients with severe asthma require chronic corticosteroid treatment to maintain asthma control. Are the reduction in oral corticosteroid (OCS) use and the clinical efficacy observed with dupilumab treatment maintained long-term in patients with severe OCS-dependent asthma? The LIBERTY ASTHMA TRAVERSE study (ClinicalTrials.gov identifier: NCT02134028) was a multinational, multicenter, single-arm, open-label extension study in patients ≥ 12 years of age with asthma who participated in previous dupilumab studies. Treatment consisted of dupilumab 300 mg every 2 weeks for up to 96 weeks. In this analysis, we present the data from patients who initially enrolled in the LIBERTY ASTHMA VENTURE study (ClinicalTrials.gov identifier: NCT02528214), a 24-week placebo-controlled study of dupilumab in patients with OCS-dependent severe asthma, and continued in the TRAVERSE study. The subgroups analyzed were: those who received dupilumab in both (dupilumab/dupilumab group) and those who received placebo in the VENTURE study and dupilumab in the TRAVERSE study (placebo/dupilumab group). Outcomes included OCS use, exacerbation rates, and measures of lung function and asthma control. Ninety patients treated with dupilumab/dupilumab and 97 patients treated with placebo/dupilumab in the VENTURE study were enrolled and treated in the TRAVERSE study, with a mean OCS dosage of 11.0 mg/d (dupilumab) and 11.6 mg/d (placebo) at VENTURE study baseline. At TRAVERSE week 0, the mean daily OCS dosage was 3.1 mg/d and 6.4 mg/d (percentage decrease from the VENTURE study baseline, 68.8% and 41.3%) for the dupilumab/dupilumab group and placebo/dupilumab group, respectively, and decreased to 2.2 mg/d and 4.9 mg/d (78.3% and 53.4%) at week 48 and to 1.2 mg/d and 3.0 mg/d (89.3% and 74.4%) at week 96, respectively. Exacerbation rates were low during the TRAVERSE study. Further improvements from the VENTURE to TRAVERSE studies also were seen in FEV1 and 5-item Asthma Control Questionnaire scores. Safety findings were consistent with the known dupilumab safety profile. In the open-label TRAVERSE study, dupilumab demonstrated the ability to sustain the OCS dosage reduction from the parent OCS-sparing study, while maintaining a low exacerbation rate and improved lung function. ClinicalTrials.gov; Nos.: NCT02134028 (TRAVERSE) and NCT02528214 (VENTURE); URL: www.clinicaltrials.gov FOR EDITORIAL COMMENT, SEE PAGE 4Take-home PointsStudy Question: Are the reduction in oral corticosteroid (OCS) use and the clinical efficacy observed with dupilumab treatment maintained in the long-term in patients with severe OCS-dependent asthma?Results: Percentage reductions from baseline in mean daily OCS dosages observed in patients previously receiving dupilumab (68.8%) and placebo (41.3%) at the start of the TRAVERSE long-term follow-up further decreased (week 48: dupilumab/dupilumab, 78.3%; placebo/dupilumab, 53.4%; week 96: dupilumab/dupilumab, 89.3%; placebo/dupilumab, 74.4%) and treatment benefits on clinical outcomes were sustained for the 2-year duration of the study.Interpretation: In the open-label TRAVERSE study, dupilumab sustained the OCS dosage reduction seen in the parent OCS-sparing study, while maintaining a low exacerbation rate and improved lung function. FOR EDITORIAL COMMENT, SEE PAGE 4 Study Question: Are the reduction in oral corticosteroid (OCS) use and the clinical efficacy observed with dupilumab treatment maintained in the long-term in patients with severe OCS-dependent asthma? Results: Percentage reductions from baseline in mean daily OCS dosages observed in patients previously receiving dupilumab (68.8%) and placebo (41.3%) at the start of the TRAVERSE long-term follow-up further decreased (week 48: dupilumab/dupilumab, 78.3%; placebo/dupilumab, 53.4%; week 96: dupilumab/dupilumab, 89.3%; placebo/dupilumab, 74.4%) and treatment benefits on clinical outcomes were sustained for the 2-year duration of the study. Interpretation: In the open-label TRAVERSE study, dupilumab sustained the OCS dosage reduction seen in the parent OCS-sparing study, while maintaining a low exacerbation rate and improved lung function. Despite the availability of biologics, many patients with severe asthma still require chronic oral corticosteroids (OCSs) to maintain asthma control.1O’Byrne P.M. Pedersen S. Lamm C.J. Tan W.C. Busse W.W. START Investigators GroupSevere exacerbations and decline in lung function in asthma.Am J Respir Crit Care Med. 2009; 179: 19-24Crossref PubMed Scopus (351) Google Scholar, 2Goleva E. Hauk P.J. Boguniewicz J. Martin R.J. Leung D.Y.M. Airway remodeling and lack of bronchodilator response in steroid-resistant asthma.J Allergy Clin Immunol. 2007; 120: 1065-1072Abstract Full Text Full Text PDF PubMed Scopus (85) Google Scholar, 3Shaw D.E. Sousa A.R. Fowler S.J. et al.Clinical and inflammatory characteristics of the European U-BIOPRED adult severe asthma cohort.Eur Respir J. 2015; 46: 1308-1321Crossref PubMed Scopus (403) Google Scholar However, chronic OCS use is limited in preventing exacerbations or sustaining lung function improvement and carries known systemic side effects.4Huscher D. Thiele K. Gromnica-Ihle E. et al.Dose-related patterns of glucocorticoid-induced side effects.Ann Rheum Dis. 2009; 68: 1119-1124Crossref PubMed Scopus (375) Google Scholar,5Ververeli K. Chipps B. Oral corticosteroid–sparing effects of inhaled corticosteroids in the treatment of persistent and acute asthma.Ann Allergy Asthma Immunol. 2004; 92: 512-522Abstract Full Text PDF PubMed Scopus (21) Google Scholar Therefore, a need exists for asthma therapies that can improve asthma control while also leading to a durable OCS reduction effect. Dupilumab, a fully human VelocImmune (Regeneron Pharmaceuticals, Inc)-derived6Macdonald L.E. Karow M. Stevens S. et al.Precise and in situ genetic humanization of 6 Mb of mouse immunoglobulin genes.Proc Natl Acad Sci U S A. 2014; 111: 5147-5152Crossref PubMed Scopus (245) Google Scholar,7Murphy A.J. Macdonald L.E. Stevens S. et al.Mice with megabase humanization of their immunoglobulin genes generate antibodies as efficiently as normal mice.Proc Natl Acad Sci U S A. 2014; 111: 5153-5158Crossref PubMed Scopus (300) Google Scholar monoclonal antibody, blocks the shared receptor component for IL-4 and IL-13, cytokines that are key and central drivers of multiple type 2 diseases,8Gandhi N.A. Pirozzi G. Graham N.M.H. Commonality of the IL-4/IL-13 pathway in atopic diseases.Expert Rev Clin Immunol. 2017; 13: 425-437Crossref PubMed Scopus (292) Google Scholar,9Le Floc’h A. Allinne J. Nagashima K. et al.Dual blockade of IL-4 and IL-13 with dupilumab, an IL-4Rα antibody, is required to broadly inhibit type 2 inflammation.Allergy. 2020; 75: 1188-1204Crossref PubMed Scopus (175) Google Scholar thus inhibiting their signaling. Dupilumab is approved for patients with type 2 inflammatory diseases, including atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyps.10United States Food and Drug AdministrationDUPIXENT® (dupilumab). Highlights of prescribing information. 2019 United States Food and Drug Administration website.https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761055s0141bl.pdfDate accessed: June 15, 2021Google Scholar,11European Medicines AgencyDUPIXENT® (dupilumab). Summary of product characteristics. European Medicines Agency website.https://ec.europa.eu/health/documents/community-register/2019/20190801145601/anx_145601_en.pdfDate accessed: June 15, 2021Google Scholar The phase 3 LIBERTY ASTHMA VENTURE study (ClinicalTrials.gov identifier: NCT02528214) assessed the OCS-sparing effect of add-on dupilumab 300 mg every 2 weeks vs placebo in adults with OCS-dependent severe asthma.12Rabe K.F. Nair P. Brusselle G. et al.Efficacy and safety of dupilumab in glucocorticoid-dependent severe asthma.N Engl J Med. 2018; 378: 2475-2485Crossref PubMed Scopus (747) Google Scholar Before randomization, patients completed the OCS dosage optimization period lasting 3 to 10 weeks, which ensured that patients enrolled into the VENTURE study were receiving the lowest dosage of OCS required to manage symptoms. After randomization, OCS dosages were reduced according to the protocol-specified OCS down-titration algorithm from week 4 to week 20, and then the dosage achieved at week 20 was maintained up to week 24. At week 24, dupilumab significantly reduced OCS use by 70.1% from baseline compared with 41.9% for placebo. In addition to the decreased use of OCS in this population, dupilumab also reduced the severe exacerbation rate by 59% and improved prebronchodilator FEV1 by 0.22 L compared with placebo.12Rabe K.F. Nair P. Brusselle G. et al.Efficacy and safety of dupilumab in glucocorticoid-dependent severe asthma.N Engl J Med. 2018; 378: 2475-2485Crossref PubMed Scopus (747) Google Scholar The LIBERTY ASTHMA TRAVERSE study, a single-arm, open-label extension study (ClinicalTrials.gov identifier: NCT02134028), evaluated the long-term safety, tolerability, and efficacy of dupilumab added onto standard-of-care background controller therapy in adults and adolescents who enrolled from a previous dupilumab study (including the VENTURE study). The aim of this analysis was to evaluate the maintenance of OCS reduction and clinical efficacy among patients treated with dupilumab who are OCS-dependent who completed the VENTURE study and enrolled in the TRAVERSE study. The TRAVERSE study was a multinational, multicenter, single-arm, open-label extension study in patients who participated in previous dupilumab studies. The primary objective of the TRAVERSE study was to evaluate the long-term safety of dupilumab. The assessment of long-term efficacy in the different patient populations was a secondary study objective. The study design, all safety outcomes (including those in VENTURE patients who rolled over into the TRAVERSE study), and efficacy outcomes in patients who are not OCS dependent were reported previously.13Wechsler M.E. et safety and efficacy of dupilumab in patients with asthma an open-label extension Respir Med. Full Text Full Text PDF PubMed Scopus Google Scholar The study was in with the of the of and the of was from all patients their or in the study. The and and were approved by and data for the dupilumab was in the M.E. et safety and efficacy of dupilumab in patients with asthma an open-label extension Respir Med. Full Text Full Text PDF PubMed Scopus Google Scholar received dupilumab 300 mg every 2 weeks, with an duration of up to 96 weeks. The treatment period was to 48 weeks a enrolled in the TRAVERSE study the were treated for 96 weeks, those enrolled the were treated for 48 weeks. The efficacy and OCS dosage in this are TRAVERSE study secondary analysis on patients who enrolled in the VENTURE study and rolled over into the TRAVERSE study. in the TRAVERSE study, patients were to their background therapy as maintained during the VENTURE daily OCS dosage the study by the were not by a down-titration algorithm as in the VENTURE K.F. Nair P. Brusselle G. et al.Efficacy and safety of dupilumab in glucocorticoid-dependent severe asthma.N Engl J Med. 2018; 378: 2475-2485Crossref PubMed Scopus (747) Google M.E. et safety and efficacy of dupilumab in patients with asthma an open-label extension Respir Med. Full Text Full Text PDF PubMed Scopus Google Scholar this analysis, treatment were patients who received dupilumab in the VENTURE study and continued to dupilumab in the TRAVERSE study (dupilumab/dupilumab group) and patients who received placebo in the VENTURE study and received dupilumab in the TRAVERSE study (placebo/dupilumab group). Outcomes were during study all week to the start of the TRAVERSE study. outcomes assessed included mean OCS dosage over the treatment from the VENTURE study, or parent study, baseline in OCS dosage at TRAVERSE weeks 0, and the of patients who ≥ reduction in OCS dosage and those who were fully OCS by the of the VENTURE and the of patients who maintained reductions at TRAVERSE weeks 48 and were for the of patients who an OCS OCS data were and were for patients who reported efficacy included the rates of severe asthma exacerbations during the VENTURE study and at weeks 48 and 96 of the TRAVERSE study and from in prebronchodilator FEV1 and in 5-item Asthma Control Questionnaire during the VENTURE and TRAVERSE studies. The TRAVERSE study was an open-label extension study with and are in in OCS dosage and in FEV1 and over were as with or The were as the of during the period by the in in the are as with the of patients with at as the for data were for OCS reduction in OCS and of patients OCS dosages of or ≥ mg/d over during the TRAVERSE treatment data were the of study then were on data for and the patients from the VENTURE study, a of patients enrolled in the TRAVERSE study who received dupilumab 300 mg and 97 who received placebo every 2 weeks in the VENTURE patients who received dupilumab during the VENTURE study were enrolled in to the and were not treated in the TRAVERSE study. In patients receiving dupilumab and patients receiving placebo completed 48 weeks of the TRAVERSE study, and patients who received dupilumab and patients who receiving placebo completed 96 weeks of the study of the OCS use was for VENTURE patients who rolled over to the TRAVERSE study as a OCS dosage was for of of and of patients at weeks 0, and 96, respectively. not OCS as a and data for TRAVERSE patients at are in and were reported previously by et M.E. et safety and efficacy of dupilumab in patients with asthma an open-label extension Respir Med. Full Text Full Text PDF PubMed Scopus Google and at VENTURE Study for and in the TRAVERSE data reported by et atopic or of severe asthma exacerbations in the FEV1 are as or mean 5-item Asthma Control Asthma of inhaled OCS oral data reported by et M.E. et safety and efficacy of dupilumab in patients with asthma an open-label extension Respir Med. Full Text Full Text PDF PubMed Scopus Google Scholar in a are as or mean 5-item Asthma Control Asthma of inhaled OCS oral The mean OCS dosage at was 11.0 mg/d with dupilumab and 11.6 mg/d with placebo. the of the OCS-sparing VENTURE study, mean OCS use decreased in both the dupilumab and placebo study with a reduction in the dupilumab group At week of the TRAVERSE study, among the patients who rolled over to that study, the mean daily OCS dosage was 3.1 mg/d (dupilumab/dupilumab group) and 6.4 mg/d (placebo/dupilumab and this decreased to 2.2 mg/d and 4.9 mg/d at week 48 and 1.2 mg/d and 3.0 mg/d at week 96 for the patients treated with dupilumab/dupilumab and patients treated with placebo/dupilumab with OCS data at respectively, as the the reduction in OCS dosage continued to over in the TRAVERSE study analysis was the demonstrated consistent findings with the mean OCS reduction mean OCS dosage low the TRAVERSE study as the of patients with OCS dosage reductions At the of the VENTURE study, of patients treated with dupilumab/dupilumab and of 97 patients treated with placebo/dupilumab achieved at a reduction in OCS dosage from baseline. patients treated with dupilumab/dupilumab and patients treated with placebo/dupilumab OCS dosage data at week 48 of the TRAVERSE study. reduction of at in OCS dosage observed in the VENTURE study was sustained in the TRAVERSE study among of patients treated with dupilumab/dupilumab and of patients treated with placebo/dupilumab with OCS dosage data at TRAVERSE week and in of patients treated with dupilumab/dupilumab and of patients treated with placebo/dupilumab at TRAVERSE week of patients treated with dupilumab/dupilumab and of 97 patients treated with placebo/dupilumab reduced OCS to mg at the of the VENTURE study. of patients (dupilumab/dupilumab group) and 48 of patients (placebo/dupilumab group) with data sustained this reduction at TRAVERSE week and of patients (dupilumab/dupilumab group) and 20 of 20 patients (placebo/dupilumab group) at TRAVERSE week At the of the VENTURE study, 48 of patients treated with dupilumab/dupilumab and of 97 patients treated with placebo/dupilumab were of OCS of patients treated with dupilumab/dupilumab and of patients treated with placebo/dupilumab with OCS data of OCS treatment at TRAVERSE week and of patients treated with dupilumab/dupilumab and of patients treated with placebo/dupilumab continued to of OCS treatment at TRAVERSE week The reductions in observed during the VENTURE study in patients treated with dupilumab were sustained during the TRAVERSE study, and patients who received placebo during the VENTURE study reductions in during the TRAVERSE study. those VENTURE patients who enrolled in the TRAVERSE study, the of at the the VENTURE was for patients receiving dupilumab and placebo decreased in patients treated with dupilumab vs patients treated with placebo patients during the VENTURE study vs the TRAVERSE study, low in patients treated with dupilumab/dupilumab (week week and decreased in patients treated with placebo/dupilumab (week week VENTURE patients enrolled in the TRAVERSE study exacerbations over the of the (dupilumab/dupilumab group) and (placebo/dupilumab group) of patients exacerbations during weeks 48 of the TRAVERSE study, and (dupilumab/dupilumab group) and (placebo/dupilumab group) of patients were during weeks 48 96 of the TRAVERSE study FEV1 an improvement from to VENTURE week 24, and this improvement was sustained the treatment period of the TRAVERSE study. At patients treated with dupilumab/dupilumab and patients treated with placebo/dupilumab a mean prebronchodilator FEV1 of L and respectively. FEV1 improvements observed in patients treated with dupilumab in the VENTURE study were sustained during the TRAVERSE study. In patients treated with placebo/dupilumab, a improvement in FEV1 was achieved to dupilumab, with a mean from to TRAVERSE week 2 of L week 96 of the mean from in FEV1 was L in patients treated with dupilumab/dupilumab and L in patients treated with placebo/dupilumab also an improvement from with sustained reductions the TRAVERSE study. At the mean in patients treated with dupilumab/dupilumab and patients treated with placebo/dupilumab were and respectively. At week of the TRAVERSE study, the mean improved from by in patients treated with dupilumab/dupilumab and in patients treated with At week 48 of the TRAVERSE study, the mean improved from by in patients treated with dupilumab/dupilumab and in patients treated with placebo/dupilumab In the safety of VENTURE patients was in the dupilumab/dupilumab group and placebo/dupilumab group during the TRAVERSE study, as by et M.E. et safety and efficacy of dupilumab in patients with asthma an open-label extension Respir Med. Full Text Full Text PDF PubMed Scopus Google Scholar and in The reported were and were reported in of patients (dupilumab/dupilumab group) and of patients (placebo/dupilumab treatment of were observed in of patients (dupilumab/dupilumab group) and of patients (placebo/dupilumab group) decrease in mean was observed during the TRAVERSE study, an was seen in a of VENTURE patients receiving placebo who over to dupilumab in the TRAVERSE study. of patients with severe asthma dependent on systemic corticosteroids to maintain use of oral corticosteroids for severe J 2018; PubMed Google E. M.E. et of severe asthma data from the Asthma 2020; Full Text Full Text PDF PubMed Scopus Google Scholar OCS-sparing studies demonstrated the ability of add-on therapy to a reduction in OCS in patients with severe K.F. Nair P. Brusselle G. et al.Efficacy and safety of dupilumab in glucocorticoid-dependent severe asthma.N Engl J Med. 2018; 378: 2475-2485Crossref PubMed Scopus (747) Google P.J. et effect of in asthma.N Engl J Med. 2014; PubMed Scopus Google P. S. K.F. et effect of in severe asthma.N Engl J Med. 2017; PubMed Scopus Google Scholar data are limited to long-term maintenance of OCS Oral corticosteroid effects of receptor treatment 2 years of Med. 2020; Full Text Full Text PDF PubMed Scopus Google M. K. et efficacy and safety of in patients with a Asthma PubMed Google Scholar or sustained improvements in exacerbation rate or lung function in this The data that patients with severe OCS-dependent asthma treated with dupilumab can sustain reduction in OCS while also maintaining improvements in clinical analysis that the OCS-sparing effect of dupilumab that was demonstrated in the VENTURE K.F. Nair P. Brusselle G. et al.Efficacy and safety of dupilumab in glucocorticoid-dependent severe asthma.N Engl J Med. 2018; 378: 2475-2485Crossref PubMed Scopus (747) Google Scholar was maintained the TRAVERSE study. In the OCS-sparing VENTURE study, patients treated with dupilumab were to a of OCS reduction compared with placebo. and of the patients treated with dupilumab who rolled over to the TRAVERSE study reduced OCS dosage by ≥ and to mg/d at the of the VENTURE study, respectively. In to the VENTURE study, in which OCS dosage was reduced according to an in the TRAVERSE study, and patients decreased the OCS dosage at their and was not that patients to a decreased OCS dosage at the rate as in the VENTURE study. After over to the TRAVERSE study, patients treated with dupilumab/dupilumab were to or their background OCS of the lack of reduction in OCS dosage during the TRAVERSE study, a decrease in background OCS dosage was not observed for patients who from placebo to dupilumab, as observed in the VENTURE sustained OCS dosage reductions in the placebo/dupilumab group were observed over patients who achieved a ≥ reduction in OCS dosage at the of the VENTURE study were to maintain this reduction weeks 48 and 96 of the TRAVERSE study, and patients who OCS treatment at the of the VENTURE study were to maintain this reduction weeks 48 and analysis also demonstrated the long-term safety data of dupilumab also by et M.E. et safety and efficacy of dupilumab in patients with asthma an open-label extension Respir Med. Full Text Full Text PDF PubMed Scopus Google and sustained improvements in clinical efficacy in patients dependent on OCS with asthma up to 96 weeks, with continued low exacerbation rates and sustained improvements in lung function and asthma control in patients dupilumab In patients who were to placebo in the VENTURE study and then over to dupilumab in the TRAVERSE study, exacerbation rates decreased and improvements in lung function and asthma control were observed that were with those in patients treated with The safety analysis over 96 weeks of the TRAVERSE study a safety to that observed in the VENTURE K.F. Nair P. Brusselle G. et al.Efficacy and safety of dupilumab in glucocorticoid-dependent severe asthma.N Engl J Med. 2018; 378: 2475-2485Crossref PubMed Scopus (747) Google Scholar the safety observed in this of patients who participated in the VENTURE study is to the from the TRAVERSE M.E. et safety and efficacy of dupilumab in patients with asthma an open-label extension Respir Med. Full Text Full Text PDF PubMed Scopus Google Scholar analysis of patients were included at which is of the that the treatment duration to 48 weeks. patients with OCS data were included at weeks 48 and 96 were those with as The primary of the TRAVERSE study was safety, and efficacy was a secondary OCS dosage data were and was not for which was the of not OCS dosage OCS the the the VENTURE algorithm in reductions in OCS use in patients receiving placebo. the TRAVERSE study was to evaluate the long-term efficacy of dupilumab and findings that dupilumab was to sustain the reduced achieved during the VENTURE study, TRAVERSE findings in the of patients who were from placebo to dupilumab to a of patients with OCS-dependent severe In we demonstrated that in a with severe asthma and chronic OCS at long-term to dupilumab sustained reduction in OCS dosage and improvement in clinical for up to 96 weeks. The dupilumab safety during the TRAVERSE study was consistent with that seen during the VENTURE study. M. to all of the data in the study and for the of the data and the of the data D. M. E. K. and J. M. P. E. M. P. J. and M. to the and of the study. M. and M. and the M. and D. participated in the of the and for and for the and of data and was by and Pharmaceuticals, The reported to the D. S. is an for Pharmaceuticals, and received from Pharmaceuticals, and and received clinical from Pharmaceuticals, M. E. from Pharmaceuticals, and and and from and K. and from and Pharmaceuticals, J. M. is a for and and from and and from and M. are of and or both in the E. J. A. P. J. M. and P. M. are of and or both in the D. 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