OCS Reduction | NUCALA (mepolizumab) for HCPs

Daily OCS dose reduction

NUCALA demonstrated proven reduction in daily OCS dose while maintaining asthma control vs placebo in a controlled clinical trial (P=0.008). OCS use was also evaluated in a real-world study.^1,2

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Controlled clinical trial data

Real-world evidence

Proven reduction in daily OCS dose

Trial 3 primary endpoint: Patients treated with NUCALA achieved greater reductions in daily OCS dose (Weeks 20 to 24) while maintaining asthma control vs placebo (P=0.008).¹

Daily OCS dose reduction¹

Results are descriptive.

Sensitivity analysis to primary endpoint.

CI=confidence interval; ICS=inhaled corticosteroid;
OCS=oral corticosteroid; SOC=standard of care.

View Trial 3 study design

CI=confidence interval; ICS=inhaled corticosteroid;
OCS=oral corticosteroid; SOC=standard of care.

Associated with elimination of daily OCS

In a controlled OCS reduction study (Trial 3), 14% of patients treated with NUCALA vs 8% treated with placebo eliminated daily OCS use while maintaining asthma control.¹

Real-World Study Interim Analysis²: Associated with discontinuation of maintenance OCS

Results are descriptive. Weeks 53-56 (n=125).

Real-World Study Limitations: Prespecified interim analysis of a single-arm, prospective, observational cohort study; may not reflect results from final dataset.

Real-world studies are designed to evaluate associations among variables and not to definitively establish causality. Limitations important when interpreting results: no comparator arm; differences in patient populations and data collection vs randomized controlled trials.

^*Baseline maintenance OCS dose (as prednisone equivalent mg/day) as 28-day period at initiation or within prior 6 months (n=159).

^†OCS dose assessment based upon data captured from medical records or patient recall, without documentation of asthma control.

View Trial 3 study design

View real-world study design and primary objective

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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

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.
Harrison T, Canonica GW, Chupp G, et al. Real-world mepolizumab in the prospective severe asthma REALITI-A study – initial analysis [published online ahead of print, August 13, 2020]. Eur Respir J. doi:10.1183/13993003.00151-2020.

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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