<p>Real-World Reductions in Oral Corticosteroid Use in the USA Following Mepolizumab Therapy for Severe Asthma</p>

Abstract

Background Patients with severe asthma often require oral corticosteroid (OCS) treatment. Clinical trials have demonstrated that mepolizumab can reduce OCS dependence, but real-world data are limited. Objective To evaluate the impact of mepolizumab on OCS use, asthma exacerbations, and asthma exacerbation-related costs in a real-world setting. Methods This retrospective cohort study (GSK ID: 209642; HO-19-19597) analyzed data from the MarketScan ® Commercial database (identification period: November 2015–September 2017). Patients were ≥12 years old at mepolizumab initiation (index date), had a baseline asthma diagnosis, and received ≥2 mepolizumab administrations in the first 6 months of follow-up. OCS use, asthma exacerbation rate, and asthma exacerbation-related costs were assessed in the 12-months before (baseline) and 12-months after (follow-up) mepolizumab initiation. Results Mepolizumab was associated with a 14.7% reduction in the proportion of patients with ≥1 OCS claim from baseline to follow-up (93.4% vs 79.7%; P <0.001). The mean numbers of OCS claims/patient and OCS bursts (≥20 mg prednisone equivalents for 3‒28 days) between baseline and follow-up were also reduced by 29.1% ( P <0.001) and 36.8% ( P <0.001), respectively. Reductions in chronic OCS use were demonstrated during follow-up in patients with baseline mean OCS dose ≥5mg and those with a mean OCS dose ≥10mg 90 days before index; the proportion of patients with no OCS use also increased from 6.6% to 20.3% between baseline and follow-up. Conclusion Our findings demonstrate that mepolizumab therapy is associated with reduced OCS use in patients treated in a real-world setting, potentially mitigating adverse health sequelae caused by OCS use in these patients.

Oral Corticosteroids Dependence and Biologic Drugs in Severe Asthma: Myths or Facts? A Systematic Review of Real-World Evidence

“…Indeed, the large real-world evidence on omalizumab may be related to the fact that this mAb has been present on the market for a longer time than the other mAbs included in this systematic review. Interestingly, data on mepolizumab reported from very large and long-term realworld studies [42,50,56] were generally consistent with those obtained for omalizumab with respect to both the percentage of patients that discontinued OCS and the reduction in the daily dose of OCS in those patients that still required maintenance OCS to control the disease. The only very large study [85] on reslizumab also confirmed that mAb therapy is able to halve the percentage of patients requiring maintenance OCS, although reslizumab reduced the daily dose of OCS slightly less than omalizumab and mepolizumab among the patients that continued to need OCS.…”

“…The only very large study [85] on reslizumab also confirmed that mAb therapy is able to halve the percentage of patients requiring maintenance OCS, although reslizumab reduced the daily dose of OCS slightly less than omalizumab and mepolizumab among the patients that continued to need OCS. However, we have to highlight that the daily dose of OCS at baseline in the very large studies on omalizumab [74,78,82] and mepolizumab studies [42,50,56] were generally lower than that of the very large study on reslizumab [85]. Only one large real-world study [34] has been carried out on benralizumab, which permitted OCS consumption to be abolished in all the observed patients.…”

“…The international study of Harrison et al [50] showed that the OCS dose was reduced between 23% and 51% according to the blood eosinophil count. In another very large study from a commercial database in the USA [56], mepolizumab reduced by 14.7% the proportion of patients with a ≥1 OCS claim from baseline to follow-up (1 year). Mepolizumab also reduced the numbers of OCS claims/patient and OCS bursts by 29.1% and 36.8%, respectively.…”

“…Of the 1757 potentially relevant records identified in the initial search, 59 real-world studies were deemed eligible for a qualitative analysis. Six studies were carried out on benralizumab [34][35][36][37][38][39], 1 on dupilumab [40], 18 on mepolizumab [41][42][43][44][45][46][47][48][49][50][51][52][53][54][55][56][57][58], 27 on omalizumab [18,, and 3 on reslizumab [85][86][87]. Four studies investigated different mAbs in the same report [88][89][90][91].…”

Efficacy of mepolizumab in patients with concomitant severe eosinophilic asthma and severe chronic urticaria: an example of personalized medicine?

“…The low prevalence of CU in SA, which is 0.9% and 5.6% in SEA patients treated with mepolizumab and in allergic SA patients treated with omalizumab, respectively, could be involved in this paradox. Moreover, these studies did not provide information neither on the severity nor on the response of CU to asthma treatment [4][5].…”