Relapse Reduction | NUCALA (mepolizumab) for Healthcare Professionals

NUCALA vs placebo, HR: 0.32, 95% CI: 0.21, 0.50; P<0.001

Relapse was defined as a worsening related to vasculitis, asthma, or sinonasal symptoms requiring an increase in dose of corticosteroids, increase in dose or addition of immunosuppressive therapy, or hospitalization.¹

NUCALA and placebo were administered in addition to standard of care (SOC).

I bars at Weeks 16, 32, and 52 indicate 95% confidence intervals.

NUCALA and placebo were administered in addition to standard of care (SOC). SOC was defined as OCS +/– immunosuppressants. After Week 4, OCS (prednisolone or prednisone) dose could be tapered per physician judgment or a suggested protocol.

Asthma
Relapse with active asthma symptoms and/or signs and worsening in ACQ-6 score

BVAS is a standardized, validated measure of vasculitis. Scores can range from 0 to 63, with higher scores meaning more active disease.^3,4

ACQ-6=Asthma Control Questionnaire-6; BVAS=Birmingham Vasculitis Activity Score; CI=confidence interval; HR=hazard ratio; OCS=oral corticosteroid; SOC=standard of care.

Indication & Important Safety Info

Indication

NUCALA is indicated for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).

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
Herpes zoster infections have occurred in patients receiving NUCALA. 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 with severe asthma (100 mg of NUCALA), the most common adverse reactions (≥5%) were headache, injection site reaction, back pain, and fatigue.

In clinical trials in patients with EGPA (300 mg of NUCALA), no additional adverse reactions were identified to those reported in severe asthma clinical trials. Systemic reactions, including hypersensitivity, also occurred. Manifestations included rash, pruritus, flushing, fatigue, hypertension, warm sensation in trunk and neck, cold extremities, dyspnea, stridor, and angioedema. Two of the four (50%) systemic reactions were experienced on the day of dosing.

USE IN SPECIFIC POPULATIONS
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.

MPLWCNT210121 March 2022

Reduced relapse rates

REFERENCES