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BRINSUPRI was studied in the largest clinical trial in bronchiectasis1

ASPEN was a Phase 3 placebo-controlled trial2,3

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The ASPEN study was an international, multicenter, randomized, double-blind, parallel-group, placebo-controlled Phase 3 clinical trial. Patients were 12 to 85 years of age (41 adolescents and 1680 adults) and received 1 of 2 doses of BRINSUPRI (10 mg: n=583; 25 mg: n=575) or placebo (n=563), administered once daily for 52 weeks.2,3

Patients in all arms were permitted to continue using their existing concomitant therapy.3,4

Aspen Study Design

All patients enrolled in ASPEN had a clinical history of confirmed non-cystic fibrosis bronchiectasis (NCFB) by chest computed tomography (CT). Adult patients had at least 2 documented pulmonary exacerbations prior to screening in the prior 12 months. Adolescent patients had at least 1 pulmonary exacerbation in the prior 12 months.2,3

WILLOW was a Phase 2 placebo-controlled trial2,5

WILLOW was a randomized, double-blind, placebo-controlled, parallel-group, multicenter, multinational Phase 2 clinical trial with 256 patients. Adults with NCFB received either BRINSUPRI (10 mg, 25 mg) or placebo once daily for 24 weeks.2,5

willow study design

Demographic and baseline characteristics of patients in ASPEN and WILLOW2,3,7

Patient characteristics in ASPEN were representative of real-world populations of patients with bronchiectasis.

ASPEN
(N=1721)
n (%)

WILLOW
(N=256)
n (%)

Age (years), mean (SD)
60 (16)
64 (12)
Female
1107 (64)
174 (68)
White
1266 (74)
225 (88)
Black or African American
10 (1)
4 (2)
Asian
191 (11)
23 (9)
Hispanic or Latino
511 (30)
6 (2)
≥3 PExs in prior 12 months
502 (29)
84 (33)
Former smoker
510 (30)
86 (34)
ppFEV1 post-BD, mean (SD)
74 (23)
68 (24)
Sputum positive for Pseudomonas aeruginosa
607 (35)
89 (35)
Chronic macrolide therapy
329 (19)
40 (16)
History of hypertension
558 (33)
100 (39)

Primary endpoint of ASPEN2:

Secondary endpoints (hierarchical) of ASPEN3:

Primary endpoint of WILLOW2:

BRINSUPRI was proven to reduce the risk of exacerbations2

BD=bronchodilator; EOT=end of treatment; FEV1=forced expiratory volume in 1 second; PEx=pulmonary exacerbation; ppFEV1=percent predicted forced expiratory volume in 1 second; SD=standard deviation.

Important Safety Information and Indication

WARNINGS AND PRECAUTIONS

Dermatologic Adverse Reactions
Treatment with BRINSUPRI is associated with an increase in dermatologic adverse reactions, including rash, dry skin, and hyperkeratosis. Monitor patients for development of new rashes or skin conditions and refer patients to a dermatologist for evaluation of new dermatologic findings.

Gingival and Periodontal Adverse Reactions
Treatment with BRINSUPRI is associated with an increase in gingival and periodontal adverse reactions. Refer patients to dental care services for regular dental checkups while taking BRINSUPRI. Advise patients to perform routine dental hygiene.

Live Attenuated Vaccines
It is unknown whether administration of live attenuated vaccines during BRINSUPRI treatment will affect the safety or effectiveness of these vaccines. The use of live attenuated vaccines should be avoided in patients receiving BRINSUPRI.

ADVERSE REACTIONS

The most common adverse reactions ≥2% in the ASPEN trial included upper respiratory tract infection, headache, rash, dry skin, hyperkeratosis, and hypertension. The safety profile for adult patients with NCFB in WILLOW was generally similar to ASPEN, except for a higher incidence of gingival and periodontal adverse reactions.

Less Common Adverse Reactions

Liver Function Test Elevations
In ASPEN, there was an increase from baseline in average ALT, AST, and alkaline phosphatase levels at all time points from Week 4 through Week 56 in both BRINSUPRI 10 mg and 25 mg arms compared to placebo. The incidence of ALT >3X upper limit of normal (ULN) was 0%, 1.2%, and 0.9%; the incidence of AST >3X ULN was 0.2%, 0.3%, and 0.5%; and the incidence of alkaline phosphatase >1.5X ULN was 2.5%, 4.1%, and 4.0% in patients treated with placebo and BRINSUPRI 10 mg and 25 mg, respectively.

Skin Cancers
In ASPEN, the incidence of skin cancers among patients treated with BRINSUPRI 10 mg and 25 mg was 0.5% and 1.9%, respectively, compared to 1.1% in placebo-treated patients.

Alopecia
In ASPEN, the incidence of alopecia among patients treated with BRINSUPRI 10 mg and 25 mg was 1.5% and 1.6% respectively, compared to 0.4% in placebo-treated patients.

USE IN SPECIFIC POPULATIONS

Pregnancy: There are no clinical data on the use of BRINSUPRI in pregnant women.

Lactation: There is no information regarding the presence of BRINSUPRI and/or its metabolite(s) in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for BRINSUPRI and any potential adverse effects on the breastfed child from BRINSUPRI or from the underlying maternal condition.

Pediatric use: The safety and effectiveness of BRINSUPRI for the treatment of NCFB have been established in pediatric patients aged 12 years and older. Common adverse reactions in pediatric patients aged 12 years and older enrolled in ASPEN were consistent with those in adults. The safety and effectiveness of BRINSUPRI have not been established in pediatric patients younger than 12 years of age.

INDICATION

BRINSUPRI is indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients 12 years of age and older.

Please see full Prescribing Information.

Important Safety Information and Indication

WARNINGS AND PRECAUTIONS

Dermatologic Adverse Reactions
Treatment with BRINSUPRI is associated with an increase in dermatologic adverse reactions, including rash, dry skin, and hyperkeratosis. Monitor patients for development of new rashes or skin conditions and refer patients to a dermatologist for evaluation of new dermatologic findings.

Gingival and Periodontal Adverse Reactions
Treatment with BRINSUPRI is associated with an increase in gingival and periodontal adverse reactions. Refer patients to dental care services for regular dental checkups while taking BRINSUPRI. Advise patients to perform routine dental hygiene.

Live Attenuated Vaccines
It is unknown whether administration of live attenuated vaccines during BRINSUPRI treatment will affect the safety or effectiveness of these vaccines. The use of live attenuated vaccines should be avoided in patients receiving BRINSUPRI.

ADVERSE REACTIONS

The most common adverse reactions ≥2% in the ASPEN trial included upper respiratory tract infection, headache, rash, dry skin, hyperkeratosis, and hypertension. The safety profile for adult patients with NCFB in WILLOW was generally similar to ASPEN, except for a higher incidence of gingival and periodontal adverse reactions.

Less Common Adverse Reactions

Liver Function Test Elevations
In ASPEN, there was an increase from baseline in average ALT, AST, and alkaline phosphatase levels at all time points from Week 4 through Week 56 in both BRINSUPRI 10 mg and 25 mg arms compared to placebo. The incidence of ALT >3X upper limit of normal (ULN) was 0%, 1.2%, and 0.9%; the incidence of AST >3X ULN was 0.2%, 0.3%, and 0.5%; and the incidence of alkaline phosphatase >1.5X ULN was 2.5%, 4.1%, and 4.0% in patients treated with placebo and BRINSUPRI 10 mg and 25 mg, respectively.

Skin Cancers
In ASPEN, the incidence of skin cancers among patients treated with BRINSUPRI 10 mg and 25 mg was 0.5% and 1.9%, respectively, compared to 1.1% in placebo-treated patients.

Alopecia
In ASPEN, the incidence of alopecia among patients treated with BRINSUPRI 10 mg and 25 mg was 1.5% and 1.6% respectively, compared to 0.4% in placebo-treated patients.

USE IN SPECIFIC POPULATIONS

Pregnancy: There are no clinical data on the use of BRINSUPRI in pregnant women.

Lactation: There is no information regarding the presence of BRINSUPRI and/or its metabolite(s) in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for BRINSUPRI and any potential adverse effects on the breastfed child from BRINSUPRI or from the underlying maternal condition.

Pediatric use: The safety and effectiveness of BRINSUPRI for the treatment of NCFB have been established in pediatric patients aged 12 years and older. Common adverse reactions in pediatric patients aged 12 years and older enrolled in ASPEN were consistent with those in adults. The safety and effectiveness of BRINSUPRI have not been established in pediatric patients younger than 12 years of age.

INDICATION

BRINSUPRI is indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients 12 years of age and older.

Please see full Prescribing Information.