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Real-world evidence in asthma: SPIRIVA RESPIMAT 1.25 mcg vs ICS/LABA

The only LAMA supported by 2 retrospective studies of nearly 10,000 patients with asthma1,2

Patients using SPIRIVA RESPIMAT 1.25 mcg showed fewer exacerbations, hospitalizations, and ED visits when compared to patients with asthma who only increased their ICS/LABA dose2

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SPIRIVA RESPIMAT Inhalation Spray 1.25 mcg vs Escalated ICS/LABA Dose

Exacerbations were defined as a hospitalization or an ED visit with primary diagnosis of asthma.2

ICS, inhaled corticosteroid; LABA, long-acting beta₂-agonist; LAMA, long-acting antimuscarinic agent; ED, emergency department.

Comparable results were seen in a second retrospective cohort study comparing patients with asthma taking tiotropium in combination with ICS vs patients with asthma taking LABA medication in combination with ICS (N=1,899).1

Results from real-world studies are not intended for comparison with clinical trials. Real-world studies were observational trials. Differences in study designs, patient populations, outcome definitions, and methods of collecting data make it difficult to make comparisons with clinical trials or with each other. Real-world data should be viewed as complementary information.

Study Design

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In this retrospective cohort study, patients with asthma taking ICS/LABA therapy that added SPIRIVA RESPIMAT 1.25 mcg were compared to those that increased their ICS/LABA dose or renewed/maintained highest dose ICS/LABA. This study extracted data from 2 retrospective data sources, IMS PharMetrics and EMRClaims+. It included 123,359 eligible non-SPIRIVA RESPIMAT patients and 2619 patients on SPIRIVA RESPIMAT who were matched with 5238 non-SPIRIVA RESPIMAT patients using propensity score matching. Data were extracted from January 2014 to December 2018. The study compared patients who used SPIRIVA RESPIMAT 1.25 mcg in addition to baseline ICS/LABA dose to those who escalated their treatment, either from low-dose ICS/LABA to medium-dose or from medium-dose to high-dose or maintained use of high-dose ICS/LABA. The day their treatment changed was defined as the index date. The primary outcome was risk of exacerbation after the index date and was analyzed using a Cox Proportional Hazards model that considers both occurrence of and time to occurrence of the first event. Exacerbations were defined as either a hospitalization or an ED visit with primary diagnosis of asthma. The secondary outcomes included rate of exacerbations and healthcare resource measures, such as asthma-related hospitalizations and asthma-related ED visits. Rate of exacerbations was found by calculating the proportion of patients with at least 1 exacerbation within 6 months and 1 year after the index date. Healthcare resource measures were analyzed by calculating the rate (per 100 person-years) of all-cause and asthma-related hospitalizations, or ED visits, or outpatient visits within 1 year after the index date. Secondary outcomes required follow-ups within 1 year of the index date, limiting the amount of data available to calculate those endpoints.2

LIMITATIONS: The retrospective design makes it challenging to establish causality between the treatments and difference in outcomes. Limitations include lack of information about events and rate of events that do not result in a paid claim, actual SABA use, inhaler technique, medication adherence, and influence of comorbidities of uncontrolled symptoms. In addition, SABA refills, which was used as a surrogate endpoint for asthma control, do not necessarily reflect patient symptoms, activity limitation, and actual SABA use. Further, bias may have been introduced because of remnant confounding after propensity score matching (PSM) and the different follow-up durations between the two treatment groups.2

ICS, inhaled corticosteroid; LABA, long-acting beta₂-agonist; ED, emergency department; SABA, short-acting beta₂-agonist.

This study extracted data from IQVIA PharMetrics Plus (PMTX+). It included 1266 patients on ICS/LABA and 633 patients on SPIRIVA RESPIMAT. Both cohorts were matched using propensity score matching. The study compared patients who used SPIRIVA RESPIMAT 1.25 mcg in combination with ICS to those using LABA medication in combination with ICS. The date of concurrent medication initiation was defined as the index date based on the date of the first prescription claim defining their add-on medication. The primary outcome was time to first severe exacerbation after the index date, with risk of exacerbation assessed using a Cox Proportional Hazards model and probability of exacerbation over time assessed using Kaplan-Meier (KM) curves. Exacerbations were defined as either a hospitalization or an ED visit with primary diagnosis of asthma. The secondary outcomes included time to first moderate-or-severe exacerbation, such as asthma-related hospitalizations and asthma-related ED visits. Rate of exacerbations was found by calculating the proportion of patients with at least 1 exacerbation within 6 months and 1 year after the index date. Healthcare resource measures were analyzed by calculating the rate (per 100 person-years) of all-cause and asthma-related hospitalizations, or ED visits, or outpatient visits within 1 year after the index date. Secondary outcomes required follow-ups within 1 year of the index date, limiting the amount of data available to calculate those endpoints.1

ICS, inhaled corticosteroid; LABA, long-acting beta₂-agonist; ED, emergency department.

INDICATION

SPIRIVA RESPIMAT, 1.25 mcg, is a bronchodilator indicated for the long-term, once-daily, maintenance treatment of asthma in patients 6 years of age and older. SPIRIVA RESPIMAT is not indicated for relief of acute bronchospasm.

IMPORTANT SAFETY INFORMATION

SPIRIVA® RESPIMAT® (tiotropium bromide) Inhalation Spray is contraindicated in patients with a hypersensitivity to tiotropium, ipratropium, or any component of this product. Immediate hypersensitivity reactions, including angioedema (including swelling of the lips, tongue, or throat), itching, or rash have been reported.

SPIRIVA RESPIMAT is intended as a once-daily maintenance treatment for asthma and should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. In the event of an attack, a rapid-acting beta2-agonist should be used.


Immediate hypersensitivity reactions, including urticaria, angioedema (including swelling of the lips, tongue, or throat), rash, bronchospasm, anaphylaxis, or itching may occur after administration of SPIRIVA RESPIMAT. If such a reaction occurs, discontinue SPIRIVA RESPIMAT at once and consider alternative treatments. Given the similar structural formula of atropine to tiotropium, patients with a history of hypersensitivity reactions to atropine or its derivatives should be closely monitored for similar hypersensitivity reactions to SPIRIVA RESPIMAT.


Inhaled medicines, including SPIRIVA RESPIMAT, may cause paradoxical bronchospasm. If this occurs, it should be treated with an inhaled short-acting beta2-agonist, such as albuterol. Treatment with SPIRIVA RESPIMAT should be stopped and other treatments considered.


SPIRIVA RESPIMAT should be used with caution in patients with narrow-angle glaucoma. Prescribers and patients should be alert for signs and symptoms of acute narrow-angle glaucoma (e.g., eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema). Instruct patients to consult a physician immediately should any of these signs or symptoms develop.


Since dizziness and blurred vision may occur with the use of SPIRIVA RESPIMAT, caution patients about engaging in activities such as driving a vehicle, or operating appliances or machinery.


SPIRIVA RESPIMAT should be used with caution in patients with urinary retention. Prescribers and patients should be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, painful urination), especially in patients with prostatic hyperplasia or bladder-neck obstruction. Instruct patients to consult a physician immediately should any of these signs or symptoms develop.


Patients with moderate to severe renal impairment (creatinine clearance of <60 mL/min) treated with SPIRIVA RESPIMAT should be monitored closely for anticholinergic side effects.


The most common adverse reactions >2% incidence and higher than placebo with SPIRIVA RESPIMAT (placebo) in asthma trials in adults were pharyngitis 15.9% (12.4%), headache 3.8% (2.7%), bronchitis 3.3% (1.4%), and sinusitis 2.7% (1.4%). The adverse reaction profile for adolescent and pediatric patients was comparable to that observed in adult patients with asthma.


SPIRIVA RESPIMAT may interact additively with concomitantly used anticholinergic medications. Avoid administration of SPIRIVA RESPIMAT with other anticholinergic-containing drugs.


Inform patients not to spray SPIRIVA RESPIMAT into the eyes as this may cause blurring of vision and pupil dilation.

Please see full Prescribing Information, including Instructions for Use, for SPIRIVA RESPIMAT.

CL-SVR-0044 2.15.2017

REFERENCES

  1. Hanania NA, Settipane RA, Khoury S, et al. Adding tiotropium or long-acting β2-agonists to inhaled corticosteroids: asthma-related exacerbation risk and healthcare resource utilization. Allergy Asthma Proc. 2023;44(6):413-421. 

  2. Chipps B, Mosnaim G, Mathur SK, et al. Add-on tiotropium versus step-up inhaled corticosteroid plus long-acting beta-2–agonist in real-world patients with asthma. Allergy Asthma Proc. 2020;41(4):248-255.