Tezspire Drug Information
Generic name: TEZEPELUMAB-EKKO
Thymic Stromal Lymphopoietin Blocker [EPC]
Uses of Tezspire
Asthma TEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. Limitations of Use: TEZSPIRE is not indicated for the relief of acute bronchospasm or status asthmaticus.
Dosage & Administration of Tezspire
Recommended Dosage
The recommended dosage of TEZSPIRE is 210 mg administered subcutaneously once every 4 weeks. Missed Dose Information If a dose is missed, administer the dose as soon as possible. Thereafter, the patient can continue (resume) dosing on the usual day of administration.
If the next dose is already due, then administer as planned.
Preparation and Administration Instructions
TEZSPIRE vial and pre‑filled syringe are intended for administration by a healthcare provider. TEZSPIRE pre-filled pen can be administered by patients/caregivers or healthcare providers. Patients/caregivers may administer TEZSPIRE pre-filled pen after proper training in subcutaneous injection technique and after the healthcare provider determines it is appropriate.
Each vial, pre-filled syringe and pre‑filled pen contain a single dose of TEZSPIRE. • Prior to administration, remove TEZSPIRE from the refrigerator and allow it to reach room temperature. This generally takes 60 minutes. Do not expose to heat and do not shake.
Do not use if the security seal on the carton has been broken. Do not put back in the refrigerator once TEZSPIRE has reached room temperature. • Visually inspect TEZSPIRE for particulate matter and discoloration prior to administration. TEZSPIRE is a clear to opalescent, colorless to light yellow solution.
Do not use TEZSPIRE if liquid is cloudy, discolored, or if it contains large particles or foreign particulate matter. Do not use if the vial, pre-filled syringe or pre‑filled pen has been dropped or damaged or if the expiration date has passed. • Inject TEZSPIRE 210 mg (contents of one vial, one pre-filled syringe or one pre-filled pen as described below) subcutaneously into the thigh or abdomen, except for the 2 inches (5 cm) around the navel. If a healthcare provider or caregiver administers the injection, the upper arm can also be used.
A patient should not self-inject in the upper arm. TEZSPIRE should not be injected into areas where the skin is tender, bruised, erythematous, or hardened. It is recommended to rotate the injection site with each injection.
Administration Instructions for Single-Dose Pre-filled Syringe Refer to Figure 1 to identify the pre-filled syringe components for use in the administration steps. Do not remove the needle cover until Step 2 of these instructions when you are ready to inject TEZSPIRE. Do not touch the needle guard activation clips to prevent premature activation of the needle safety guard.
Figure 1 TEZSPIRE Pre-filled Syringe Components Administration Instructions for Single-Dose Pre-filled Pen These administration instructions are intended for healthcare providers use only. Patients and caregivers should refer to the TEZSPIRE pre-filled pen ‘Instructions for Use’ for more detailed instructions on the preparation and administration of TEZSPIRE pre-filled pen. Patients/caregivers may inject after proper training in subcutaneous injection technique according to the ‘Instructions for Use’, and after the healthcare provider determines it is appropriate.
Refer to Figure 2 to identify the pre-filled pen components for use in the administration steps. Figure 2 TEZSPIRE Pre-filled Pen Components Figure_1 Number_3_picture number4picture number5picture number6picture figure_2_pre-filled_pen_components figure_2-image-2 figure2_image-4 figure_2_image_5 figure_2_image_6 figure_2_image_7
| 1. | Grasp the syringe body to remove the pre-filled syringe from its carton. Do not grab the pre-filled syringe by the plunger. The pre-filled syringe may contain small air bubbles; this is normal. Do not expel the air bubbles prior to administration. | |
| 2. | Do not remove the needle cover until ready to inject. Hold the syringe body and remove the needle cover by pulling straight off. Do not hold the plunger or plunger head while removing the needle cover. You may see a drop of liquid at the end of the needle. This is normal. | |
| 3. | Gently pinch the skin and administer subcutaneously at approximately 45° angle into the recommended injection site (i.e., upper arm, thigh, or abdomen). | |
| 4. | Inject all of the medication by pushing in the plunger all the way until the plunger head is completely between the needle guard activation clips. This is necessary to activate the needle guard. | |
| 5. | After injection, maintain pressure on the plunger head and remove the needle from the skin. Release pressure on the plunger head to allow the needle guard to cover the needle. Do not re-cap the pre-filled syringe. | |
| 6. | Discard the used syringe into a sharps container. | |
| 1. | Grab the middle of the pre-filled pen body to remove the pre-filled pen from its carton. The pre-filled pen may contain small air bubbles; this is normal. Do not expel the air bubbles prior to administration. | ||
| 2. | Do not remove the cap until ready to inject. Hold the pre-filled pen body with 1 hand and carefully pull the cap straight off with your other hand. Do not touch the needle or push the orange needle guard with your finger. Do not put the cap back on the pre-filled pen. You could cause the injection to happen too soon or damage the needle. | ||
| 3. | Gently pinch the skin at the injection site or give the injection without pinching the skin. Inject TEZSPIRE by following the steps into the recommended injection site (i.e., upper arm, thigh, or abdomen). When injecting, you will hear the first click that tells you the injection has started. Press and hold the pre-filled pen for 15 seconds until you hear the second click. Do not change the position of the pre-filled pen after the injection has started. | ||
| 4. | Position the pre-filled pen. Place the orange needle guard flat against the skin (90‑degree angle). Make sure you can see the viewing window. | ||
| 5. | Press down firmly until you cannot see the orange needle guard. You will hear the first ‘click’, this tells you the injection has started. The orange plunger will move down in the viewing window during the injection. | ||
| 6. | Hold down firmly for about 15 seconds. You will hear a second ‘click’, this tells you the injection has finished. The orange plunger will fill the viewing window. | ||
| 7. | After you have completed the injection, lift the pre-filled pen straight up. The orange needle guard will slide down and lock into place over the needle. | ||
| 8. | Discard the used pre-filled pen into a sharps container. | ||
Side Effects of Tezspire
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Adult and Pediatric Patients 12 Years of Age and Older with Asthma The safety of TEZSPIRE in asthma was based on the pooled safety population from PATHWAY and NAVIGATOR, which consists of 665 adult and pediatric patients 12 years of age and older with severe asthma who received at least one dose of TEZSPIRE 210 mg subcutaneously once every 4 weeks. The two placebo-controlled clinical trials were of 52 weeks duration.
In addition, a similar safety profile was seen in a trial that enrolled 150 adult patients with severe asthma who required treatment with daily oral corticosteroids. Adverse reactions that occurred at an incidence greater than or equal to 3% and more common than in the placebo group from the pooled safety population (PATHWAY and NAVIGATOR) are shown in Table 1. Table 1 Adverse Reactions with TEZSPIRE with Incidence Greater than or Equal to 3% and More Common than Placebo in Patients with Severe Asthma in the Pooled Safety Population (PATHWAY and NAVIGATOR) s Cardiovascular Events In a randomized, double-blind, long term extension trial, patients 12 years and older with severe asthma from trials NAVIGATOR and the additional trial received TEZSPIRE 210 mg subcutaneously every 4 weeks or placebo for up to 104 weeks.
In the trial, the incidence rates (IR) per 100 patient-years (PY) for serious cardiac adverse events in patients treated with TEZSPIRE or placebo were 1.08 and 0.21, respectively, with an incidence rate difference (IRD) of The types of serious cardiac adverse events were heterogeneous. In the trial, the IR per 100 PY for adjudicated major adverse cardiovascular events (MACE, defined as cardiovascular deaths, non-fatal myocardial infarctions, and non-fatal strokes) in patients treated with TEZSPIRE or placebo were 0.60 and 0.42, respectively, with an IRD of Injection Site Reactions In the pooled safety population (PATHWAY and NAVIGATOR), in which TEZSPIRE or placebo was administered using the vial by a healthcare provider, injection site reactions (e.g., injection site erythema, injection site swelling, injection site pain) occurred at a rate of 3.3% in patients treated with TEZSPIRE compared with 2.7% in patients treated with placebo. In an open-label trial of 216 patients with asthma in which TEZSPIRE was administered by healthcare providers and patients or caregivers using either the pre-filled pen or pre-filled syringe, injection site reactions (e.g., injection site erythema, injection site swelling, injection site pain) were observed in 5.7% patients using the pre-filled pen and 0% using the pre-filled syringe.
However, the trial was not designed to compare injection site reactions between patients who received TEZSPIRE by the pre-filled pen versus pre-filled syringe. Adverse Reactions in Adult Patients with Chronic Rhinosinusitis with Nasal Polyps The safety of TEZSPIRE in CRSwNP was based on WAYPOINT, a randomized, double-blind, parallel group, multicenter, placebo-controlled trial of 52 weeks duration, which consisted of 203 adult patients aged 18 years and older on standard of care treatment for CRSwNP who received at least one dose of TEZSPIRE 210 mg subcutaneously once every 4 weeks. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Hypersensitivity reactions: anaphylaxis
| Adverse Reaction | TEZSPIRE N=665 % | Placebo N=669 % |
|---|---|---|
| Pharyngitis Pharyngitis (including Pharyngitis, Pharyngitis bacterial, Pharyngitis streptococcal and Viral pharyngitis) | 4 | 3 |
| Arthralgia | 4 | 3 |
| Back pain | 4 | 3 |
| Adverse Reaction | TEZSPIRE N=203 % | Placebo N=205 % |
|---|---|---|
| Nasopharyngitis | 18 | 10 |
| Upper respiratory tract infection Upper respiratory tract infection (including Upper respiratory tract infection and Viral upper respiratory tract infection) | 12 | 8 |
| Epistaxis | 6 | 3 |
| Pharyngitis Pharyngitis (including Pharyngitis, Pharyngitis bacterial, Pharyngitis streptococcal and Viral pharyngitis) | 5 | 1 |
| Back pain | 5 | 2 |
| Influenza | 4 | 1 |
| Injection site reaction Injection site reaction (e.g., Injection site erythema, Injection site swelling and Injection site pain) | 4 | 2 |
| Arthralgia | 3 | 2 |
Warnings & Cautions for Tezspire
Hypersensitivity Reactions
Hypersensitivity reactions were observed in the clinical trials (e.g., rash and allergic conjunctivitis) following the administration of TEZSPIRE. Postmarketing cases of anaphylaxis have also been reported. These reactions can occur within hours of administration, but in some instances have a delayed onset (i.e., 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 or acute exacerbations. Do not use TEZSPIRE to treat acute bronchospasm or status asthmaticus. Patients should seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment with TEZSPIRE.
Risk Associated with 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
Thymic stromal lymphopoietin (TSLP) may be involved in the immunological response to some helminth infections. Patients with known helminth infections were excluded from participation in clinical trials. 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 treatment with TEZSPIRE and do not respond to anti-helminth treatment, discontinue treatment with 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.
Drug Interactions with Tezspire
No formal drug interaction studies have been performed with TEZSPIRE.
Pregnancy Safety for Tezspire
Pregnancy Risk Summary 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. In an enhanced pre- and post-natal development (ePPND) study conducted in cynomolgus monkeys, placental transport of tezepelumab-ekko was observed but there was no evidence of fetal harm following intravenous administration of tezepelumab-ekko throughout pregnancy at doses that produced maternal exposures up to 168 times the exposure at the maximum recommended human dose (MRHD) of 210 mg administered subcutaneously (see Data).
The estimated background risk of major birth defects and miscarriages for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is respectively.
Clinical Considerations Disease-associated maternal and/or embryo/fetal risk: In women with poorly or moderately controlled asthma, evidence demonstrates that there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. The level of asthma control should be closely monitored in pregnant women and treatment adjusted as necessary to maintain optimal control. Data Animal Data In the ePPND study, pregnant cynomolgus monkeys received tezepelumab-ekko from GD20 to GD22 (dependent on pregnancy determination), at the beginning of organogenesis, and once every 7 days until the end of gestation at doses that produced exposures up to 168 times that achieved with the MRHD (on an AUC basis with maternal intravenous doses up to 300 mg/kg/week).
There were no tezepelumab-ekko related adverse effects on maternal health, pregnancy outcome, embryo-fetal development, or neonatal growth and development up to 6.5 months of age. Tezepelumab-ekko crossed the placenta in cynomolgus monkeys and tezepelumab-ekko serum concentrations were 0.5- to 6.7-fold higher in infants relative to maternal animals.
Pediatric Use of Tezspire
- Pediatric Use Asthma The safety and effectiveness of TEZSPIRE for the add-on maintenance treatment of severe asthma have been established in pediatric patients aged 12 years and older. Compared with placebo, improvements in annualized asthma exacerbation rate ratio and FEV1 LS mean change versus placebo were observed in pediatric patients treated with TEZSPIRE. The safety profile and pharmacodynamic responses in pediatric patients were generally similar to the overall study population. The safety and effectiveness of TEZSPIRE have not been established in patients younger than 12 years of age with asthma. CRSwNP The safety and effectiveness of TEZSPIRE for the add-on maintenance treatment of inadequately controlled CRSwNP have been established in pediatric patients aged 12 years and older. Use of TEZSPIRE for this indication is supported by evidence from the adequate and well-controlled study of TEZSPIRE in adults (WAYPOINT) with the following additional data:
- Pharmacokinetic (PK) data from adult and pediatric patients aged 12 years and older with severe asthma and adult patients with CRSwNP.
- Safety data in pediatric patients aged 12 years and older with severe asthma. The safety and effectiveness of TEZSPIRE have not been established in patients younger than 12 years of age with CRSwNP.
Contraindications for Tezspire
TEZSPIRE is contraindicated in patients who have known hypersensitivity to tezepelumab-ekko or any of its excipients. Known hypersensitivity to tezepelumab-ekko or excipients.
Clinical Studies of Tezspire
Clinical Studies in Patients with Asthma
The efficacy of TEZSPIRE for add-on maintenance treatment of severe asthma was evaluated in two randomized, double-blind, parallel group, placebo-controlled clinical trials (PATHWAY and NAVIGATOR ) of 52 weeks duration. The two trials enrolled a total of 1,609 patients 12 years of age and older with severe asthma. Patients were required to have a history of 2 or more asthma exacerbations requiring oral or injectable corticosteroid treatment or 1 asthma exacerbation resulting in hospitalization in the past 12 months.
In both PATHWAY and NAVIGATOR, patients were required to have an Asthma Control Questionnaire 6 (ACQ-6) score of 1.5 or more at screening and reduced lung function at baseline. Patients were required to have been on regular treatment with medium or high-dose inhaled corticosteroids (ICS) and at least one additional asthma controller, with or without oral corticosteroids (OCS). Patients continued background asthma therapy throughout the duration of the trials.
In both trials, patients were enrolled without requiring a minimum baseline level of blood eosinophils or FeNO. The demographics and baseline characteristics of PATHWAY and NAVIGATOR are provided in Table 3 below. Table 3 Demographics and Baseline Characteristics of Patients in 35 44 EOS, Eosinophils; FEIA, Fluorescent enzyme immunoassay; FeNO, Fractional exhaled nitric oxide; FEV 1, Forced expiratory volume in one second; ICS, Inhaled corticosteroid, IgE, Immunoglobulin E; OCS, Oral corticosteroid; ppb, Parts per billion; SD, Standard deviation The results summarized below are for the recommended TEZSPIRE 210 mg subcutaneously every 4 weeks dosing regimen.
Exacerbations The primary endpoint for PATHWAY and NAVIGATOR was the rate of clinically significant asthma exacerbations measured over 52 weeks. Clinically significant asthma exacerbations were defined as worsening of asthma requiring the use of or increase in oral or injectable corticosteroids for at least 3 days, or a single depo-injection of corticosteroids, and/or emergency department visits requiring use of oral or injectable corticosteroids and/or hospitalization. In both PATHWAY and NAVIGATOR, patients receiving TEZSPIRE had significant reductions in the annualized rate of asthma exacerbations compared to placebo.
There were also fewer exacerbations requiring emergency room visits and/or hospitalization in patients treated with TEZSPIRE compared with placebo (Table 4). Table 4 Rate of Clinically Significant Exacerbations Over 52 Weeks in, patients receiving TEZSPIRE experienced fewer exacerbations than those receiving placebo regardless of baseline levels of blood eosinophils or FeNO (Figure 3). Similar results were seen in PATHWAY.
Figure 3 Annualized Asthma Exacerbation Rate Ratio Over 52 Weeks Across Different Baseline Biomarkers in NAVIGATOR The time to first exacerbation was longer for the patients receiving TEZSPIRE compared with placebo in NAVIGATOR (Figure 4). Similar findings were seen in PATHWAY. Figure 4 Kaplan-Meier Cumulative Incidence Curves for Time to First Exacerbation in NAVIGATOR Lung Function Change from baseline in FEV 1 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 FEV 1 in both trials (Table 5). Figure 5 Mean Change (95% CI) from Baseline in Pre-Bronchodilator FEV1 (L) in NAVIGATOR 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 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.
Clinically meaningful improvement (responder rate) for both measures was defined as improvement in score of 0.5 or more at end of trial. Additional Trial In a randomized, double-blind, parallel group, placebo-controlled clinical trial, the effect of TEZSPIRE (210 mg subcutaneously every 4 weeks) on reducing the use of maintenance OCS was evaluated. The trial enrolled 150 adult patients with severe asthma who required treatment with daily OCS (7.5 mg to 30 mg per day) in addition to regular use of high-dose ICS and a long-acting beta-agonist with or without additional controller(s).
TEZSPIRE did not demonstrate a statistically significant reduction in maintenance OCS dose compared with placebo (cumulative OR=1.28; 95% CI 0.69, 2.35). figure_2 figure_3 figure_4
Clinical Studies in Patients with Chronic Rhinosinusitis with Nasal Polyps The efficacy of TEZSPIRE for add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) was evaluated in a randomized, double-blind, parallel group, multicenter, placebo-controlled trial (WAYPOINT ) of 52 weeks treatment duration conducted in 408 patients aged 18 years and older on standard of care treatment for CRSwNP. This study included patients with symptomatic CRSwNP despite treatment with nasal corticosteroids, and who had systemic corticosteroids within the past 12 months and/or any history of sino-nasal surgery, or with contraindications and/or intolerance to either. Patients received TEZSPIRE 210 mg or placebo subcutaneously every 4 weeks for 52 weeks in addition to nasal corticosteroid treatment for CRSwNP.
The demographics and baseline characteristics of patients enrolled in WAYPOINT are provided in Table 6. Table 6 Demographics and Baseline Characteristics of Adult Patients in WAYPOINT AERD, Aspirin exacerbated respiratory disease; CRSwNP, Chronic rhinosinusitis with nasal polyps; CT, Computed tomography; IgE, Immunoglobulin E; IU, International units; LMK, Lund-Mackay; NCS, Nasal congestion score; NPS, Nasal polyp score; NSAID‑ERD, Nonsteroidal anti-inflammatory drug exacerbated respiratory disease; SD, Standard deviation The co-primary efficacy endpoints were change from baseline in total nasal polyp score (NPS) evaluated by nasal endoscopy at Week 52 as graded by independent blinded assessors, and change from baseline in bi-weekly mean nasal congestion score (NCS) evaluated at Week 52. For total NPS, polyps on each side of the nose were graded on a categorical scale (0=no polyps, 1=small polyps in the middle meatus not reaching below the inferior border of the middle turbinate, 2=polyps reaching below the lower border of the middle turbinate, 3=polyps reaching the lower border of the inferior turbinate or a middle meatal polyp with a score of 2 with any additional polyp medial to the middle turbinate, 4=large polyps causing complete or near complete obstruction of the inferior nasal cavity ) for a total score of 0 to 8.
Nasal congestion was rated daily by the patients on a 0 to 3 categorical severity scale (0=none, 1=mild, 2=moderate, 3=severe). Statistically significant efficacy was observed in WAYPOINT for the co-primary endpoints of improvement in total NPS and in bi-weekly mean NCS at Week 52 (Table 7). Table 7 Results of Change from Baseline in Total Nasal Polyp Score and Bi-weekly Mean Nasal Congestion Score at Week 52 in Adults with CRSwNP (WAYPOINT) Figure 6 demonstrates the time course of improvement in the mean change from baseline in NPS.
Figure 6 LS Mean Change from Baseline in Total Nasal Polyp Score up to Week 52 in Adults (WAYPOINT) Figure 7 demonstrates the time course of improvement in the bi-weekly mean change from baseline in NCS. Figure 7 LS Mean Change from Baseline in Bi-weekly Mean Nasal Congestion Score up to Week 52 in Adults (WAYPOINT) Key secondary endpoints at Week 52 included time to surgery decision and/or systemic corticosteroid use for nasal polyps, change from baseline in loss of smell, and change from baseline in Lund-Mackay (LMK) sinus CT scan score. TEZSPIRE significantly reduced the proportion of patients with need for sino-nasal surgery or systemic corticosteroids by 92% compared to placebo over 52 weeks Hazard Ratio: (Figure 8).
The loss of smell score was calculated every 2 weeks as the bi-weekly mean. TEZSPIRE significantly improved the loss of smell compared to placebo. The LS mean difference for loss of smell at Week 52 in the TEZSPIRE group versus placebo was -1.01.
The LMK sinus CT scan score evaluated the opacification of each sinus at baseline and Week 52 using a 0 to 2 scale (0=no abnormality; 1=partial opacification, 2=total opacification) deriving a maximum score of 12 per side and a total maximum score of 24 (higher scores indicate more opacification). A significant decrease in the LMK sinus CT scan score was observed. The LS mean difference for LMK sinus CT scan score at Week 52 in the TEZSPIRE group versus placebo was -5.76.
Figure_6 Figure_7 Figure_8
| PATHWAY N=550 | NAVIGATOR N=1,059 | |
|---|---|---|
| Mean age (year) (SD) | 52 (12) | 50 (16) |
| Female (%) | 66 | 64 |
| White (%) | 92 | 62 |
| Black or African American (%) | 3 | 6 |
| Asian (%) | 3 | 28 |
| Hispanic or Latino (%) | 1 | 15 |
| Never smoked (%) | 81 | 80 |
| High-dose ICS use (%) | 49 | 75 |
| OCS use (%) | 9 | 9 |
| Mean number of exacerbations in previous year (SD) | 2.4 (1.2) | 2.8 (1.4) |
| Mean duration of asthma (years) (SD) | 17 (12) | 22 (16) |
| Mean baseline % predicted FEV 1 (SD) | 60 (13) | 63 (18) |
| Mean post-bronchodilator FEV 1 reversibility (%) (SD) | 23 (20) | 15 (15) |
| Mean baseline blood EOS count (cells/µL) (SD) | 371 (353) | 340 (403) |
| Positive serum specific IgE to any perennial allergen (%) In the FEIA panel | 46 | 64 |
| Mean FeNO (ppb) (SD) | 35 (39) | 44 (41) |
| Trial | Treatment | Exacerbations per year | |
|---|---|---|---|
| Rate | Rate Ratio (95% CI) | ||
| Annualized Asthma Exacerbation Rate | |||
| PATHWAY | TEZSPIRE (N=137) | 0.20 | 0.29 (0.16, 0.51) |
| Placebo (N=138) | 0.72 | ||
| NAVIGATOR | TEZSPIRE (N=528) | 0.93 | 0.44 (0.37, 0.53) |
| Placebo (N=531) | 2.10 | ||
| Exacerbations requiring emergency room visit/hospitalization | |||
| PATHWAY | TEZSPIRE (N=137) | 0.03 | 0.15 (0.04, 0.58) |
| Placebo (N=138) | 0.18 | ||
| NAVIGATOR | TEZSPIRE (N=528) | 0.06 | 0.21 (0.12, 0.37) |
| Placebo (N=531) | 0.28 | ||
| Exacerbations requiring hospitalization | |||
| PATHWAY | TEZSPIRE (N=137) | 0.02 | 0.14 (0.03, 0.71) |
| Placebo (N=138) | 0.14 | ||
| NAVIGATOR | TEZSPIRE (N=528) | 0.03 | 0.15 (0.07, 0.22) |
| Placebo (N=531) | 0.19 | ||
| Trial | Treatment | LS Mean Change from Baseline (L) | Difference from Placebo (95% CI) |
|---|---|---|---|
| PATHWAY | TEZSPIRE (N=133) Number of patients contributing to the full analysis (FA) with at least 1 change from baseline value | 0.08 | 0.13 (0.03, 0.23) |
| Placebo (N=138) | -0.06 | ||
| NAVIGATOR | TEZSPIRE (N=527) | 0.23 | 0.13 (0.08, 0.18) |
| Placebo (N=531) | 0.10 |
| WAYPOINT N=408 Number of patients (N) =407 for mean total NPS; N=406 for mean bi-weekly NCS and mean bi-weekly loss of smell; N=404 for mean LMK sinus CT total score and mean blood eosinophils; N=389 for mean total IgE. | |
| Mean age (years) (SD) | 50 (14) |
| Male (%) | 65 |
| Mean CRSwNP duration (years) (SD) | 13 (10) |
| Patients with ≥1 prior surgery (%) | 71 |
| Patients with systemic corticosteroid use for CRSwNP in the previous year (%) | 58 |
| Mean total NPS Higher scores indicate greater disease severity or symptom severity. (SD), range 0-8 | 6.1 (1.2) |
| Mean bi-weekly NCS (SD), range 0-3 | 2.6 (0.5) |
| Mean LMK sinus CT total score (SD), range 0-24 | 19 (4) |
| Mean bi-weekly loss of smell (SD), range 0-3 | 2.9 (0.4) |
| Mean blood eosinophils (cells/µL) (SD) | 358 (238) |
| Mean total IgE IU/mL (SD) | 176 (285) |
| Asthma Includes patients with asthma or AERD or NSAID-ERD. All but 3 patients with AERD or NSAID-ERD included in this subgroup also had a diagnosis of asthma reported. (%) | 61 |
| NSAID-ERD/AERD (%) | 17 |
| TEZSPIRE 210 mg Q4W (N=203) | Placebo (N=205) | LS mean difference vs. placebo (95% CI) | |||
|---|---|---|---|---|---|
| Scores | Baseline mean | LS mean change | Baseline mean | LS mean change | |
| NPS | 6.1 | -2.47 | 6.1 | -0.47 | -2.01 (-2.33, -1.68) |
| NCS | 2.59 | -1.76 | 2.55 | -0.81 | -0.95 (-1.12, -0.78) |
| LS mean change, Least squared mean change from baseline; reduction in score indicates improvement; NCS, Nasal congestion score; NPS, Nasal polyp score | |||||
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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