Indications for: TEZSPIRE
Add-on maintenance treatment of severe asthma.
Limitations of Use:
Not for relief of acute bronchospasm or status asthmaticus.
The efficacy of Tezspire was evaluated in two randomized, double-blind, parallel group, placebo-controlled clinical trials (PATHWAY [Clinicaltrials.gov Identifier: NCT02054130] and NAVIGATOR [Clinicaltrials.gov Identifier: NCT03347279]) of 52 weeks duration. The two trials enrolled a total of 1609 patients 12 years of age and older with severe asthma.
PATHWAY was a 52-week dose-ranging exacerbation trial that enrolled 550 adult patients with severe asthma who received treatment with tezepelumab-ekko 70 mg subcutaneously every 4 weeks, Tezspire 210 mg subcutaneously every 4 weeks, tezepelumab-ekko 280 mg subcutaneously every 2 weeks, or placebo subcutaneously.
NAVIGATOR was a 52-week exacerbation trial that enrolled 1061 patients (adult and pediatric patients 12 years of age and older) with severe asthma who received treatment with Tezspire 210 mg subcutaneously every 4 weeks or placebo subcutaneously every 4 weeks.
The primary endpoint for PATHWAY and NAVIGATOR was the rate of clinically significant asthma exacerbations measured over 52 weeks.
- In both studies, patients receiving Tezspire had significant reductions in the annualized rate of asthma exacerbations vs placebo (NAVIGATOR: 0.93 vs 2.10; rate ratio, 0.44 [95% CI, 0.37-0.53]; PATHWAY: 0.20 vs 0.72; rate ratio, 0.29 [95% CI, 0.16-0.51]).
- There were also fewer exacerbations requiring emergency room visits and/or hospitalization in patients treated with Tezspire compared with placebo (NAVIGATOR: 0.06 vs 0.28; rate ratio, 0.21 [95% CI, 0.12-0.37]; PATHWAY: 0.03 vs 0.18; rate ratio, 0.15 [95%, 0.04-0.58]).
- Exacerbations requiring hospitalization were also reduced in the Tezspire group vs placebo (NAVIGATOR: 0.03 vs 0.19; rate ratio, 0.15 [95% CI, 0.07-0.22]; PATHWAY: 0.02 vs 0.14; rate ratio, 0.14 [95% CI, 0.03-0.71]).
The time to first exacerbation was longer for the patients receiving Tezspire compared with placebo in NAVIGATOR (see full labeling). Similar findings were seen in PATHWAY.
Change from baseline in FEV1 was assessed as a secondary endpoint in PATHWAY and NAVIGATOR. Compared with placebo, Tezspire provided clinically meaningful improvements in the mean change from baseline in FEV1 in both trials.
Over 52 weeks, the mean change from baseline in FEV1 (difference from Tezspire and placebo) was:
- 0.13 L; (95% CI, 0.08-0.18) in NAVIGATOR,
- 0.13 L; (95% CI, 0.03-0.23) in PATHWAY.
In NAVIGATOR, improvement in FEV1 was seen as early as 2 weeks after initiation of treatment and was sustained through week 52.
Patient Reported Outcomes
Changes from baseline in Asthma Control Questionnaire 6 (ACQ-6) and Standardized Asthma Quality of Life Questionnaire for ages 12 and older [AQLQ(S)+12] were also assessed as secondary endpoints in PATHWAY and NAVIGATOR.
In both trials, more patients treated with Tezspire compared to placebo had a clinically meaningful improvement in ACQ-6 and AQLQ(S)+12. The responder rate for both measures was defined as improvement in score of 0.5 or more at the end of trial.
- In NAVIGATOR, the ACQ-6 responder rate for Tezspire was 86% vs 77% for placebo (OR=1.99; 95% CI, 1.43-2.76) and the AQLQ(S)+12 responder rate for Tezspire was 78% vs 72% for placebo (OR=1.36; 95% CI, 1.02-1.82).
- Similar findings were seen in PATHWAY.
Give by SC inj into upper arm, thigh, or abdomen (except around the navel). Rotate inj sites. 210mg once every 4 weeks.
<12yrs: not established.
Not for treating acute asthma symptoms or exacerbations. Avoid abrupt discontinuation of any corticosteroids upon Tezspire initiation; reduce gradually if appropriate. Treat pre-existing helminth infections prior to initiation; if infection develops and unresponsive to antihelmintics, discontinue Tezspire until resolves. Do not inject into tender, bruised, erythematous, or hardened skin. Pregnancy (during 3rd trimester). Nursing mothers.
Thymic stromal lymphopoietin (TSLP) blocker.
Avoid concomitant live attenuated vaccines.
Pharyngitis, arthralgia, back pain; hypersensitivity reactions (eg, rash, allergic conjunctivitis).
The elimination half-life was ~26 days.
Generic Drug Availability:
Single-dose vial, prefilled syringe, or prefilled pen—1