Clinical Trials | NUCALA (mepolizumab) for HCPs

NUCALA is the only anti-IL-5 with a 4.5-year open-label safety and efficacy study

Initially evaluated in controlled clinical trials for exacerbation reduction and OCS reduction. Later studied in open-label studies as shown below.

Long-term exacerbation reduction

Patients with zero exacerbations

Long-term reduction in daily OCS use

NUCALA: Associated with protection from exacerbations over 4.5 years

4.5-year open-label study¹

Reduction in annual exacerbation rate bar chart

Results are descriptive.

Secondary endpoint: Annualized exacerbation rate: 0.68 (95% CI: 0.60, 0.78).

*Based on exacerbations reported from the time a patient enrolled until study withdrawal. Median duration 3.8 years.

View 4.5-year open-label study design and primary endpoint (safety)

NUCALA: Patients with zero exacerbations over 4.5 years

4.5-year open-label study²Number of exacerbations*
All patients, N=347

4.5-year open-label safety study exacerbation chart

33%

ZERO exacerbations
over 4.5 years

53%

≤1 exacerbation
over 4.5 years

Results are descriptive.

*Based on exacerbations reported from the time a patient enrolled until study withdrawal. Median duration 3.8 years.¹

Secondary endpoint: Annualized exacerbation rate: 0.68 (95% CI: 0.60, 0.78).¹

View 4.5-year open-label study design and primary endpoint (safety)

NUCALA: Associated with reduced daily OCS dose over 1.5 years

Post hoc analysis: Durability of OCS dose reduction^3†

Results are descriptive.

^†Durability of response was defined as OCS dose reduction when combined with Trial 3 data. Graph includes only patients who completed the open-label study.

NOTE: OCS reduction method in the open-label study was at clinician discretion.

Open-label extension study²:

Results are descriptive.

OCS dose ranges at end of treatment²

Average OCS Dose (mg/day)	1-year NUCALA (n=58)	1.5-years NUCALA (n=57)
0	28%	32%
>0–5	29%	37%
>5–10	22%	14%
Total ≤10	79%	82%
Total >10	21%	18%

Results are descriptive.

93% of patients from Trial 3 enrolled in the open-label extension trial³

View Trial 3 study design

View 1-year open-label extension study design and primary endpoint (safety)

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Indication

Important Safety Information

Indication & Important Safety Info

NUCALA is indicated for the add-on maintenance treatment of patients 6 years and older with severe asthma with an eosinophilic phenotype. NUCALA is not indicated for the relief of acute bronchospasm or status asthmaticus.

CONTRAINDICATIONS
NUCALA should not be administered to patients with a history of hypersensitivity to mepolizumab or excipients in the formulation.

Important Safety Information

CONTRAINDICATIONS
NUCALA should not be administered to patients with a history of hypersensitivity to mepolizumab or excipients in the formulation.

WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
Hypersensitivity reactions (eg, anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, rash) have occurred with NUCALA. These reactions generally occur within hours of administration but can have a delayed onset (ie, days). If a hypersensitivity reaction occurs, discontinue NUCALA.

Acute Asthma Symptoms or Deteriorating Disease
NUCALA should not be used to treat acute asthma symptoms, acute exacerbations, or acute bronchospasm.

Opportunistic Infections: Herpes Zoster
In controlled clinical trials, 2 serious adverse reactions of herpes zoster occurred with NUCALA compared to none with placebo. Consider vaccination if medically appropriate.

Reduction of Corticosteroid Dosage
Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with NUCALA. Decreases in corticosteroid doses, if appropriate, should be gradual and under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

Parasitic (Helminth) Infection
Treat patients with pre-existing helminth infections before initiating therapy with NUCALA. If patients become infected while receiving NUCALA and do not respond to anti-helminth treatment, discontinue NUCALA until infection resolves.

ADVERSE REACTIONS
In clinical trials in patients receiving NUCALA, the most common adverse reactions (≥5%) were headache, injection site reaction, back pain, and fatigue. Systemic reactions (allergic and nonallergic), including hypersensitivity, also occurred. Manifestations included rash, pruritus, headache, myalgia, and flushing; the majority were experienced the day of dosing.

USE IN SPECIFIC POPULATIONS
A pregnancy exposure registry monitors pregnancy outcomes in women exposed to NUCALA during pregnancy. To enroll call 1-877-311-8972 or visit www.mothertobaby.org/asthma.

The data on pregnancy exposures are insufficient to inform on drug-associated risk. Monoclonal antibodies, such as mepolizumab, are transported across the placenta in a linear fashion as the pregnancy progresses; therefore, potential effects on a fetus are likely to be greater during the second and third trimesters.

Please see full Prescribing Information and Patient Information for NUCALA.

MPTWCNT200079 January 2021.

References

Khatri S, Moore W, Gibson PG, et al. Assessment of the long-term safety of mepolizumab and durability of clinical response in patients with severe eosinophilic asthma. J Allergy Clin Immunol. 2019;143(5):1742-1751.
Data on file, GSK.
Lugogo N, Domingo C, Chanez P, et al. Long-term efficacy and safety of mepolizumab in patients with severe eosinophilic asthma: a multi-center, open-label, phase IIIb study. Clin Ther. 2016;38(9):2058-2070.e1.

To report SUSPECTED ADVERSE REACTIONS, contact GSK at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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