ASTRAZENECA PLC The Phase IIa COURSE trial was a proof-of-concept study in people with moderate to very severe chronic obstructive pulmonary disease (COPD) with a broad range of blood eosinophil counts (BEC) and irrespective of emphysema, chronic bronchitis or smoking status.
The primary results showed that treatment with
Importantly, in patients with BEC 150 cells/-microL, tezepelumab led to a nominally significant reduction of 37% in the rate of moderate or severe exacerbations compared to placebo.1 Studies suggest that approximately 65% of bio-eligible patients with COPD have a BEC greater than or equal to 150 cells/L.2 In patients with BEC 300 cells/-microL tezepelumab led to a numerical reduction of 46% in the rate of moderate or severe exacerbations.1
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A subgroup analysis of the COURSE trial also showed treatment with tezepelumab resulted in numerical improvements in lung function as measured by forced expiratory volume (FEV1) (improvement of 63mL and 146mL in BEC 150 and 300 cells/L respectively, compared to placebo) and in quality of life as measured by the St. George's Respiratory Questionnaire (SGRQ) score (reduction of 4.2 points and 9.5 points in BEC 150 and 300 cells/L respectively).1 The safety and tolerability profile for tezepelumab was consistent with its approved severe asthma indication; the most frequently reported (>10%) adverse events for tezepelumab were worsening of COPD (12.1%) and incidents of COVID-19 infections (14.5%) (this trial commenced in July 2019).1
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
Hypersensitivity reactions were observed in the clinical trials (eg, rash and allergic conjunctivitis) following the administration of TEZSPIRE. Postmarketing cases of anaphylaxis have been reported. These reactions can occur within hours of administration, but in some instances have a delayed onset (ie, days). In the event of a hypersensitivity reaction, consider the benefits and risks for the individual patient to determine whether to continue or discontinue treatment with TEZSPIRE.
Acute Asthma Symptoms or Deteriorating Disease
TEZSPIRE should not be used to treat acute asthma symptoms, acute exacerbations, acute bronchospasm, or status asthmaticus.
Abrupt Reduction of Corticosteroid Dosage
Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with TEZSPIRE. Reductions in corticosteroid dose, if appropriate, should be gradual and performed 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
It is unknown if TEZSPIRE will influence a patient's response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with TEZSPIRE. If patients become infected while receiving TEZSPIRE and do not respond to anti-helminth treatment, discontinue TEZSPIRE until infection resolves.
Live Attenuated Vaccines
The concomitant use of TEZSPIRE and live attenuated vaccines has not been evaluated. The use of live attenuated vaccines should be avoided in patients receiving TEZSPIRE.
ADVERSE REACTIONS
The most common adverse reactions (incidence 3%) are pharyngitis, arthralgia, and back pain.
USE IN SPECIFIC POPULATIONS
There are no available data on TEZSPIRE use in pregnant women to evaluate for any drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Placental transfer of monoclonal antibodies such as tezepelumab-ekko is greater during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy.
INDICATION
TEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.
TEZSPIRE is not indicated for the relief of acute bronchospasm or status asthmaticus.
Notes
COURSE Phase IIa trial
COURSE was a Phase IIa multicentre, randomized, double-blind, placebo-controlled, parallel group trial designed to evaluate the safety and efficacy of tezepelumab in adults with moderate to very severe chronic obstructive pulmonary disease (COPD) receiving triple inhaled maintenance therapy, and having had two or more documented COPD exacerbations in the 12 months prior to Visit 1. A total of 337 patients were randomized globally, with patients stratified by region and prior number of exacerbations (two vs. three or more). Patients received tezepelumab 420 mg, or placebo, administered via subcutaneous injection at the trial site every four weeks over a 52-week treatment period. The trial included a post-treatment follow-up period of 12 weeks.
Chronic Obstructive Pulmonary Disease (COPD)
COPD refers to a group of lung diseases, including chronic bronchitis and emphysema, that cause airflow blockage and breathing-related problems.4 COPD is the third leading cause of death due to chronic disease and the sixth leading cause of mortality in
The lungs and heart are fundamentally linked and work together.7 COPD mechanisms elevate the risk of both lung and heart events, including severe or even fatal COPD exacerbations and cardiac events, known as cardiopulmonary risk.8-11 Approximately 1 in 5 patients with COPD will die within a year of their first hospitalization for an exacerbation, and pulmonary and cardiac events are a key driver of mortality and the most common reasons for death in patients with COPD.
TEZSPIRE
TEZSPIRE (tezepelumab) is being developed by
In 2020,
In addition, we are also collaborating with
Respiratory & Immunology
Respiratory & Immunology, part of BioPharmaceuticals, is one of
With common pathways and underlying disease drivers across respiratory and immunology,
About
Contact:
Tel: +1 302 885 2677
Tel: +1 302 885 2677
Email: usmediateam@astrazeneca.com
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