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CLINICAL EFFICACY

NUCALA: Associated with protection from exacerbations in a real-world study

Interim analysis: Exacerbation rate at 12 months1*

Study Limitations1
These data are from a prespecified interim analysis and may not reflect results from the final dataset.

Real-world studies are designed to evaluate associations among variables and not to definitively establish causality. These limitations are important when interpreting results: lack of comparator arm, differences in patient populations and data collection vs randomized controlled trials.

Results are descriptive.

  •   *Defined as deterioration in asthma requiring use of systemic corticosteroids and/or an ED visit and/or hospital admission.

DESCRIPTION1
Ongoing, 2-year, prospective, multinational, single-arm, observational cohort study assessing the real-world effectiveness and pattern of use of NUCALA 100 mg every 4 weeks in 368 adult patients with SEA who met the eligibility requirements to initiate NUCALA. Data were collected prospectively at usual asthma healthcare visits. A 12-month period of relevant medical data was required prior to enrollment and collected retrospectively. Baseline visit was first administration of NUCALA.

OBJECTIVES1
Assessed 12-month post-treatment period vs 12-month pre-treatment period (baseline); Primary: exacerbation rate; Secondary: maintenance OCS use.

NUCALA: Associated with elimination of maintenance OCS in a real-world study

Results are descriptive.

STUDY LIMITATIONS1
These data are from a prespecified interim analysis of a prospective observational cohort study of 368 patients and may not reflect results from the final dataset.

Real-world studies are designed to evaluate associations among variables and not to definitively establish causality. These limitations are important when interpreting results: lack of comparator arm, differences in patient populations and data collection vs randomized controlled trials.

  •   *OCS dose assessment was based upon data captured from medical records or patient recall, without documentation of asthma control.
  •   Baseline maintenance OCS dose at initiation and/or within prior 6 months.

SIRIUS2
Unlike REALITI-A, the primary endpoint was percent reduction in daily OCS dose while maintaining asthma control. NUCALA reduced daily OCS while maintaining asthma control vs placebo (P=0.008).

Following the optimization phase, 14% of patients treated with NUCALA vs 8% treated with placebo eliminated daily OCS use while maintaining asthma control.

REFERENCES:

  1. Data on file, GSK.
  2. Bel EH, Wenzel SE, Thompson PJ, et al, Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. N Engl J Med. 2014;371(13):1189-1197.