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TEZSPIRE (tezepelumab) is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) for whom therapy with systemic corticosteroids, and/or surgery do not provide adequate disease control.1
Tezspire is also indicated for the treatment of severe asthma and has been shown to significantly reduce asthma exacerbation rates.1-3
For severe asthma indication click here.
Find out more about the TEZSPIRE data in severe asthma here.
CRSwNP is a heterogeneous inflammatory disease of the upper airway that is characterised by chronic sinonasal inflammation and the formation of nasal polyps.4-6 Approximately 21% of patients with moderate-to-severe asthma report a history of CRSwNP.7,8
CRSwNP has previously been managed with long-term intranasal corticosteroids, short courses of oral corticosteroids, endoscopic sinus surgery, and revision surgery.6,9,10 However, these approaches often fail to provide long-term disease control, resulting in disease and symptom recurrence.11
Many patients with severe asthma have comorbid nasal polyps.7
Patients with uncontrolled CRSwNP have a significant burden of symptoms such as:6
Uncontrolled CRSwNP has a considerable impact on health-related quality of life and patients report that symptoms have a major impact on daily activities.12,13
Corticosteroid burden is high in patients with severe CRSwNP, particularly in patients with comorbid asthma, and even short courses of SCS have been found to increase the incidence of AEs.10
Rates of steroid use are higher in patients who have undergone surgery for nasal polyps than the general population of patients with moderate-severe CRSwNP.14 Approximately half of patients with CRSwNP have undergone nasal surgery.15
Nasal polyp surgery is not always a long-term solution to CRSwNP. Over a 10-year period, a retrospective database analysis showed that more than 85% of patients with CRSwNP required revision surgery. In patients with comorbid asthma, the median time to revision surgery was 7 years compared with non-comorbid patients, in whom the median time was 9 years.16
CRSwNP has a substantial economic burden due to increased healthcare resource utilisation. Chronic rhinosinusitis is estimated to cost the UK healthcare system £16.8 billion per year, and on average, a patient with chronic rhinosinusitis misses 19 days of work per year.17
a.Data were retrospectively analysed using Hospital Episode Statistics (HES) database (25), for patients in England, aged 18 or over with a diagnosis of nasal polyposis and a relevant sinus surgery from April 2010-March 2020.
TEZSPIRE is an anti-TSLP monoclonal antibody that binds to TSLP upon its release by epithelial cells in the upper and lower airways.1,18,19
TSLP is a key driver of inflammation in the upper and lower airways that is elevated in patients with severe asthma and severe CRSwNP.18,20,21 Targeting TSLP at the top of the inflammatory cascade inhibits the inflammatory response.18
Disrupting the inflammatory pathways by blocking TSLP can reduce clinical manifestations of severe asthma and severe CRSwNP.2,4,5
The mechanism of action of Tezspire in asthma or CRSwNP has not been definitively established
Adapted from Wechsler ME, et al. Respir Res. 2020.
*The mechanism of action for TEZSPIRE in asthma or CRSwNP has not been definitively established.
WAYPOINT was a randomised, Phase III, double-blind, parallel-group, multicentre, placebo-controlled study (N=408) that evaluated the efficacy and safety of Tezspire in adult patients with severe, uncontrolled chronic rhinosinusitis with nasal polyps.4,5
In the WAYPOINT trial, patients were recruited across 112 sites in ten countries. Patients were randomly assigned in a 1:1 ratio to receive TEZSPIRE 210 mg (n=203) or placebo (n=205) subcutaneously Q4W for 52 weeks.4,5
Inclusion criteria:
Exclusion criteria:
Co-primary endpoints:
Key secondary endpoints:
Additional secondary endpoints:
TEZSPIRE resulted in significantly greater improvements from baseline than placebo in NPS and NCS4,5
LSM difference vs placebo: −2.08; 95% CI: −2.40, −1.76;* p<0.0001†1,4,5
Figures adapted from Lipworth BJ, et al. N Engl J Med. 2025;392(12):1178-88.
LSM difference vs placebo: −1.04; 95% CI: −1.21, −0.87;* p<0.0001†1,4,5
TEZSPIRE resulted in significantly greater improvements from baseline than placebo in NPS and NCS4
LSM difference vs placebo: −27.44; 95% CI: −32.51, −22.37;* p<0.0001†1,4
Adapted from Lipworth BJ, et al. N Engl J Med. 2025;392(12):1178-88.
92% reduction in the need for surgery and/or use of SCS over 52 weeks vs placebo1,4
(HR: 0.08; week 52 event rates, 5.7% [Tezspire] vs 31.4% [placebo]; ARR, 25.7%; 95% CI, 0.03 to 0.16;* P<0.0001)†1,4
Adapted from Lipworth BJ, et al. N Engl J Med. 2025;392(12):1178-88.
98% reduction in the need for surgery over 52 weeks vs placebo1,4,5
(HR: 0.02; week 52 event rates, 0.5% [Tezspire] vs 22% [placebo]; ARR, 21.5%; 95% CI, 0.00 to 0.09;* P<0.0001)†1,4,5
89% reduction in the use of SCS over 52 weeks vs placebo1,4,5
(HR: 0.11; week 52 event rates, 5.2% [Tezspire] vs 19.3% [placebo]; ARR, 14.1%; 95% CI, 0.04 to 0.25;* P<0.0001)†1,4,5
At Week 52, TEZSPIRE demonstrated a −1.26 point improvement from baseline in NPSD loss-of-smell score vs −0.26 points with placebo. LSM difference vs placebo: –1.01 (95% CI: –1.18, –0.83;* p<0.0001† 1
TEZSPIRE demonstrated improvements in NPSD loss-of-smell score from Day 7 of –0.10 points from baseline vs –0.02 points with placebo. LSM difference vs placebo: –0.08 (95% CI: –0.15, –0.02;* p=0.009)†33,34
LSM difference vs placebo: −6.96; 95% CI: −8.09, −5.83;* p<0.0001†1,4,5
LSM difference vs placebo: −5.70; 95% CI: −6.37, −5.03;* p<0.0001†1,4,5
Among patients with coexisting asthma, there was no apparent difference between the TEZSPIRE and placebo groups in the change from baseline in pre-BD FEV1 at Week 52 (TEZSPIRE 0.02 L vs placebo 0.03 L; LSM difference vs placebo: −0.01 L; 95% CI: −0.12, 0.11)‡4,5
9.31 point increase in UPSIT score from baseline at Week 52 vs -0.19 with placebo.
LSM difference vs placebo: 9.50 (95% CI: 7.84, 11.16; p<0.001±±)4,5
-1.20 point improvement in ACQ-6 score from baseline at Week 52 vs -0.82 with placebo.
LSM difference vs placebo: -0.39 (95% CI: -0.59, -0.19; n.s.)‡4,5§
*Denotes statistically significant after multiplicity adjustment1
†All p-values are reported as unadjusted1
‡Assessed in the subgroup of patients with coexisting asthma (n=122 in TEZSPIRE group; n=126 in placebo group)4,5
±±An unadjusted p-value is presented and is not multiplicity corrected
§This endpoint was not included in the multiplicity hierarchy
Diagnosed with adult-onset asthma at age 39, with a 3-year history of nasal polyps
The safety profile of TEZSPIRE in patients with CRSwNP was consistent with previous studies in patients with severe asthma, no new safety concerns were identified in WAYPOINT.
The most commonly reported adverse reactions during treatment for asthma are arthralgia (3.8%) and pharyngitis (4.1%) and during treatment for CRSwNP is pharyngitis (5.4%).1 In WAYPOINT, rates of adverse events and serious adverse events were similar with TEZSPIRE compared to placebo.4,5
TEZSPIRE is contraindicated in patients who have known hypersensitivity to tezepelumab or to any of its excipients listed in the SmPC1
Additional safety information on special warnings and precautions can be found in the full TEZSPIRE SmPC1
*Patients with CRSwNP or asthma exacerbations. Exacerbations of CRSwNP, defined in the protocol as worsening of symptoms that led to the use of systemic glucocorticoids or systemic antibiotics for at least 3 consecutive days or resulted in hospitalization; no events resulted in hospitalization of patients in either trial group. Asthma exacerbations defined in the protocol as a worsening of asthma that led to any of the following: a temporary burst of systemic glucocorticoids for at least 3 consecutive days, an emergency department or urgent care visit due to asthma that resulted in systemic glucocorticoid therapy for at least 3 consecutive days, or an inpatient hospitalization (for ≥24 hours) due to asthma.
† Serious adverse events were those that resulted in death, were life-threatening, led to hospitalization or prolongation of hospitalization, caused persistent or clinically significant disability or incapacity, or were deemed to be an important medical event
.‡ One patient in the placebo group died from bacterial sepsis.
The table below presents the adverse reactions from clinical studies in patients with severe asthma and CRSwNP who received at least one dose of Tezspire in trials of 52 weeks duration, and from post-marketing experience.
The frequency of adverse reactions is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); and not known (cannot be estimated from available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
| System organ class | Adverse reactions | Frequency |
|---|---|---|
| Infections and infestations | Pharyngitisa | Common |
| Immune system disorders | Hypersensitivity (including anaphylactic reaction) | Not known |
| Skin and subcutaneous tissue disorders | Rashb | Common |
| Musculoskeletal and connective tissue disorders | Arthralgia | Common |
| General disorders and administration site conditions | Injection site reactionc | Common |
a Pharyngitis was defined by the following grouped preferred terms: pharyngitis, pharyngitis bacterial, pharyngitis streptococcal and viral pharyngitis.
b Rash was defined by the following grouped preferred terms: rash, rash pruritic, rash erythematous, rash maculo-papular, rash macular.
c See 'Description of selected adverse reactions'.
Injection site reactions
In the pooled safety data from PATHWAY and NAVIGATOR, injection site reactions (e.g. injection site erythema, injection site swelling, injection site pain) occurred at a rate of 3.8% in patients treated with tezepelumab 210 mg subcutaneous every 4 weeks (Q4W).
Learn more about the safety profile of TEZSPIRE in severe asthma here.
GB-72789 | June 2026
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to AstraZeneca by visiting https://contactazmedical.astrazeneca.com/ or by calling 0800 783 0033.
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