{"id":59393,"date":"2024-05-20T01:04:44","date_gmt":"2024-05-19T23:04:44","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/new-data-presented-at-ats-2024-show-the-potential-of-tezspire-to-play-a-role-in-the-future-treatment-of-chronic-obstructive-pulmonary-disease\/"},"modified":"2024-05-20T01:04:44","modified_gmt":"2024-05-19T23:04:44","slug":"new-data-presented-at-ats-2024-show-the-potential-of-tezspire-to-play-a-role-in-the-future-treatment-of-chronic-obstructive-pulmonary-disease","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/new-data-presented-at-ats-2024-show-the-potential-of-tezspire-to-play-a-role-in-the-future-treatment-of-chronic-obstructive-pulmonary-disease\/","title":{"rendered":"New data presented at ATS 2024 show the potential of TEZSPIRE to play a role in the future treatment of chronic obstructive pulmonary disease"},"content":{"rendered":"<div>\n<p class=\"bwalignc\">\n<b><i>Late-breaking results from the Phase IIa COURSE trial provide insight into TEZSPIRE\u2019s impact on COPD exacerbations in patients with a broad range of eosinophil levels<\/i><\/b><\/p>\n<p>WILMINGTON, Del.&#8211;(BUSINESS WIRE)&#8211;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.<sup>1<\/sup> The primary results showed that treatment with AstraZeneca and Amgen\u2019s TEZSPIRE<sup>\u00ae<\/sup> (tezepelumab) led to a 17% numerical reduction in the annual rate of moderate or severe COPD exacerbations compared to placebo at week 52, which was not statistically significant (90% CI (Confidence Interval): -6, 36], p [1-sided]=0.1042).<sup>1<\/sup> The results are being presented at the American Thoracic Society (ATS) International Conference.<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20240519716817\/en\/484259\/5\/Logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20240519716817\/en\/484259\/22\/Logo.jpg\"><\/a><br \/><a href=\"https:\/\/mms.businesswire.com\/media\/20240519716817\/en\/484259\/5\/Logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20240519716817\/en\/484259\/21\/Logo.jpg\"><\/a><\/p>\n<p>\nImportantly, in patients with BEC \u2265150 cells\/\u00b5L, tezepelumab led to a nominally significant reduction of 37% in the rate of moderate or severe exacerbations compared to placebo.<sup>1<\/sup> Studies suggest that approximately 65% of bio-eligible patients with COPD have a BEC greater than or equal to 150 cells\/\u03bcL.<sup>2<\/sup> In patients with BEC \u2265300 cells\/\u00b5L tezepelumab led to a numerical reduction of 46% in the rate of moderate or severe exacerbations.<sup>1<\/sup> (Table 1.)<\/p>\n<p>\nDr Dave Singh, Professor of Respiratory Pharmacology at the University of Manchester and lead investigator on the trial, said: \u201c<!-- no quote -->I believe that biologics will play a critical role in the future care of COPD and trials such as the tezepelumab COURSE trial are central to understanding and shaping the treatment landscape. The tezepelumab COURSE results are particularly important as they show activity in COPD across a broad patient population including those with baseline blood eosinophil counts greater than 150 cells\/\u03bcL.\u201d<\/p>\n<p>\nSharon Barr, Executive Vice President, BioPharmaceuticals R&amp;D, AstraZeneca, said: \u201c<!-- no quote -->These proof-of-concept results from the COURSE trial are encouraging as they signal the potential efficacy of tezepelumab in a broad range of people with COPD irrespective of emphysema, chronic bronchitis and smoking status. As a result of these promising data, we are actively in Phase III planning for tezepelumab in COPD.\u201d<\/p>\n<p>\nA 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 \u2265150 and \u2265300 cells\/\u03bcL respectively, compared to placebo) and in quality of life as measured by the St. George\u2019s Respiratory Questionnaire (SGRQ) score (reduction of 4.2 points and 9.5 points in BEC \u2265150 and \u2265300 cells\/\u03bcL respectively).<sup>1<\/sup> The safety and tolerability profile for tezepelumab was consistent with its approved severe asthma indication; the most frequently reported (&gt;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).<sup>1<\/sup> (Table 2.)<\/p>\n<p>\n<b>COURSE Phase IIa analysis:<\/b><\/p>\n<p>\n<b>Table 1: Tezepelumab impact on COPD exacerbations versus placebo over 52 weeks<sup>1<\/sup><\/b><\/p>\n<table cellspacing=\"0\" class=\"bwtablemarginb bwblockalignl bwwidth100\">\n<tr>\n<td class=\"bwvertalignt bwtopsingle bwsinglebottom bwleftsingle bwrightsingle bwpadl0 bwwidth33\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n\u00a0<\/p>\n<\/td>\n<td class=\"bwvertalignt bwtopsingle bwsinglebottom bwrightsingle bwpadl0 bwwidth31\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n<b>Reduction in exacerbations compared to placebo<\/b><\/p>\n<\/td>\n<td class=\"bwvertalignt bwtopsingle bwsinglebottom bwrightsingle bwpadl0 bwwidth36\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n<b>Annualized rate of exacerbations<\/b><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwsinglebottom bwleftsingle bwrightsingle bwpadl0\" colspan=\"3\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n<b><i>Moderate or severe exacerbations<\/i><\/b><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwsinglebottom bwleftsingle bwrightsingle bwpadl0 bwwidth33\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n<b>Overall population <\/b>(n=333)<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl0 bwwidth31\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n17% (90% CI: -6, 36)<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl0 bwwidth36\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n1.75 in tezepelumab group versus 2.11 in placebo group<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwsinglebottom bwleftsingle bwrightsingle bwpadl0 bwwidth33\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n<b>BEC less than 150 cells\/\u03bcL <\/b>(n=137)<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl0 bwwidth31\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n-19% (95% CI: -90, 25)<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl0 bwwidth36\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n2.04 in tezepelumab group versus 1.71 in placebo group<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwsinglebottom bwleftsingle bwrightsingle bwpadl0 bwwidth33\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n<b>BEC greater than or equal to 150 cells\/\u03bcL <\/b>(n=196)<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl0 bwwidth31\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n37% (95% CI: 7, 57)<\/p>\n<p class=\"bwcellpmargin\">\n\u00a0<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl0 bwwidth36\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n1.52 in tezepelumab group versus 2.40 in placebo group<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwsinglebottom bwleftsingle bwrightsingle bwpadl0 bwwidth33\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n<b>BEC greater than or equal to 300 cells\/\u03bcL<\/b> (n=56)<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl0 bwwidth31\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n46% (95% CI: -15, 75)<\/p>\n<p class=\"bwcellpmargin\">\n\u00a0<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl0 bwwidth36\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n1.20 in tezepelumab group versus 2.24 in placebo group<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwsinglebottom bwleftsingle bwrightsingle bwpadl0\" colspan=\"3\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n<b><i>Severe exacerbations<\/i><\/b><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwsinglebottom bwleftsingle bwrightsingle bwpadl0 bwwidth33\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n<b>Overall population <\/b>(n=333)<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl0 bwwidth31\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n48% (95% CI: -11, 76)<\/p>\n<p class=\"bwcellpmargin\">\n\u00a0<\/p>\n<\/td>\n<td class=\"bwvertalignt bwsinglebottom bwrightsingle bwpadl0 bwwidth36\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n0.13 in tezepelumab group versus 0.25 in placebo group<\/p>\n<\/td>\n<\/tr>\n<\/table>\n<p>\n<b>Table 2: Tezepelumab impact on quality of life and lung function versus placebo over 52 weeks<sup>1<\/sup><\/b><\/p>\n<table cellspacing=\"0\" class=\"bwtablemarginb bwblockalignl\">\n<tr>\n<td class=\"bwvertalignt bwsinglebottom bwleftsingle bwrightsingle bwpadl0 bwtopsingle\" colspan=\"1\" rowspan=\"2\">\n<p class=\"bwcellpmargin\">\n\u00a0<\/p>\n<\/td>\n<td class=\"bwvertalignt bwtopsingle bwsinglebottom bwrightsingle bwpadl0\" colspan=\"3\" rowspan=\"1\">\n<p class=\"bwalignc bwcellpmargin\">\n<b>Lung function as measured by pre-bronchodilator forced expiratory volume (FEV1, \u00b5L)<\/b><\/p>\n<\/td>\n<td class=\"bwvertalignt bwtopsingle bwsinglebottom bwrightsingle bwpadl0\" colspan=\"3\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n<b>Quality of life improvement as measured by St. George\u2019s Respiratory Questionnaire (SGRQ) score<\/b><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwvertalignm bwalignl\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin bwalignl\">\n\u00a0<\/p>\n<p class=\"bwcellpmargin bwalignl\">\n<b>Tezepelumab<\/b><\/p>\n<p class=\"bwcellpmargin bwalignl\">\n<b>(n)\/LS Mean<\/b><\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwvertalignm bwalignl\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin bwalignl\">\n\u00a0<\/p>\n<p class=\"bwcellpmargin bwalignl\">\n<b>Placebo<\/b><\/p>\n<p class=\"bwcellpmargin bwalignl\">\n<b>(n)\/LS<\/b><\/p>\n<p class=\"bwcellpmargin bwalignl\">\n<b>Mean<\/b><\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwvertalignm bwalignl\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin bwalignl\">\n\u00a0<\/p>\n<p class=\"bwcellpmargin bwalignl\">\n<b>LS mean<\/b><\/p>\n<p class=\"bwcellpmargin bwalignl\">\n<b>difference<\/b><\/p>\n<p class=\"bwcellpmargin bwalignl\">\n<b>(95% CI)<\/b><\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwvertalignm bwalignl\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin bwalignl\">\n\u00a0<\/p>\n<p class=\"bwcellpmargin bwalignl\">\n<b>Tezepelumab<\/b><\/p>\n<p class=\"bwcellpmargin bwalignl\">\n<b>(n)\/LS Mean<\/b><\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwvertalignm bwalignl\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin bwalignl\">\n\u00a0<\/p>\n<p class=\"bwcellpmargin bwalignl\">\n<b>Placebo<\/b><\/p>\n<p class=\"bwcellpmargin bwalignl\">\n<b>(n)\/LS<\/b><\/p>\n<p class=\"bwcellpmargin bwalignl\">\n<b>Mean<\/b><\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwvertalignm bwalignl\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin bwalignl\">\n\u00a0<\/p>\n<p class=\"bwcellpmargin bwalignl\">\n<b>LS mean<\/b><\/p>\n<p class=\"bwcellpmargin bwalignl\">\n<b>difference<\/b><\/p>\n<p class=\"bwcellpmargin bwalignl\">\n<b>(95% CI)<\/b><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwsinglebottom bwleftsingle bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwalignc bwcellpmargin\">\n<b>BEC less than 150 cells\/\u03bcL<\/b><\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwvertalignm bwalignl\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin bwalignl\">\n73\/-0.002<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwvertalignm bwalignl\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin bwalignl\">\n63\/-0.053<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwvertalignm bwalignl\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin bwalignl\">\n0.051 (-0.012,0.114)<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwvertalignm bwalignl\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin bwalignl\">\n69\/-1.91<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwvertalignm bwalignl\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin bwalignl\">\n60\/-0.30<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwvertalignm bwalignl\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin bwalignl\">\n-1.62 (-6.69, 3.45)<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwsinglebottom bwleftsingle bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwalignc bwcellpmargin\">\n<b>BEC greater than or equal to 150 cells\/\u03bcL<\/b><\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwpadr0 bwvertalignm bwalignl\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin bwalignl\">\n\u00a0<\/p>\n<p class=\"bwcellpmargin bwalignl\">\n90\/0.049<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwvertalignm bwalignl\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin bwalignl\">\n\u00a0<\/p>\n<p class=\"bwcellpmargin bwalignl\">\n103\/-0.014<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwvertalignm bwalignl\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin bwalignl\">\n\u00a0<\/p>\n<p class=\"bwcellpmargin bwalignl\">\n0.063 (0.009, 0.116)<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwvertalignm bwalignl\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin bwalignl\">\n\u00a0<\/p>\n<p class=\"bwcellpmargin bwalignl\">\n88\/-7.08<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwvertalignm bwalignl\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin bwalignl\">\n\u00a0<\/p>\n<p class=\"bwcellpmargin bwalignl\">\n96\/-2.85<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwvertalignm bwalignl\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin bwalignl\">\n\u00a0<\/p>\n<p class=\"bwcellpmargin bwalignl\">\n-4.23 (-8.51, 0.06)<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwsinglebottom bwleftsingle bwrightsingle bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwalignc bwcellpmargin\">\n<b>BEC counts greater than or equal to 300 cells\/\u03bcL<\/b><\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwvertalignm bwalignl\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin bwalignl\">\n\u00a0<\/p>\n<p class=\"bwcellpmargin bwalignl\">\n24\/0.160<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwvertalignm bwalignl\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin bwalignl\">\n\u00a0<\/p>\n<p class=\"bwcellpmargin bwalignl\">\n31\/0.013<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwvertalignm bwalignl\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin bwalignl\">\n0.146 (0.044, 0.248)<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwvertalignm bwalignl\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin bwalignl\">\n\u00a0<\/p>\n<p class=\"bwcellpmargin bwalignl\">\n22\/-10.22<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwvertalignm bwalignl\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin bwalignl\">\n\u00a0<\/p>\n<p class=\"bwcellpmargin bwalignl\">\n27\/-0.68<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwvertalignm bwalignl\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin bwalignl\">\n\u00a0<\/p>\n<p class=\"bwcellpmargin bwalignl\">\n-9.53 (-18.11, -0.96)<\/p>\n<\/td>\n<\/tr>\n<\/table>\n<p>\n<b>INDICATIONS AND LIMITATIONS OF USE \/ ISI<\/b><\/p>\n<p>\n<b>TEZSPIRE<sup>\u00ae<\/sup> (tezepelumab)<\/b><\/p>\n<p>\n<b>CONTRAINDICATIONS<\/b><\/p>\n<p>\nKnown hypersensitivity to tezepelumab-ekko or excipients.<\/p>\n<p>\n<b>WARNINGS AND PRECAUTIONS<\/b><\/p>\n<p>\n<b>Hypersensitivity Reactions<\/b><\/p>\n<p>\nHypersensitivity 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.<\/p>\n<p>\n<b>Acute Asthma Symptoms or Deteriorating Disease<\/b><\/p>\n<p>\nTEZSPIRE should not be used to treat acute asthma symptoms, acute exacerbations, acute bronchospasm, or status asthmaticus.<\/p>\n<p>\n<b>Abrupt Reduction of Corticosteroid Dosage<\/b><\/p>\n<p>\nDo 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.<\/p>\n<p>\n<b>Parasitic (Helminth) Infection<\/b><\/p>\n<p>\nIt is unknown if TEZSPIRE will influence a patient\u2019s 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.<\/p>\n<p>\n<b>Live Attenuated Vaccines<\/b><\/p>\n<p>\nThe 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.<\/p>\n<p>\n<b>ADVERSE REACTIONS<\/b><\/p>\n<p>\nThe most common adverse reactions (incidence \u22653%) are pharyngitis, arthralgia, and back pain.<\/p>\n<p>\n<b>USE IN SPECIFIC POPULATIONS<\/b><\/p>\n<p>\nThere 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.<\/p>\n<p>\n<b>INDICATION<\/b><\/p>\n<p>\nTEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.<\/p>\n<p>\nTEZSPIRE is not indicated for the relief of acute bronchospasm or status asthmaticus.<\/p>\n<p>\n<b>Please see full <\/b><a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.azpicentral.com%2Fpi.html%3Fproduct%3Dtezspire&amp;esheet=54001772&amp;newsitemid=20240519716817&amp;lan=en-US&amp;anchor=Prescribing+Information&amp;index=1&amp;md5=848933eea68f38d61fa449ca76b4b1fe\" rel=\"nofollow noopener\" shape=\"rect\"><b>Prescribing Information<\/b><\/a><b>, including <\/b><a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.azpicentral.com%2Fpi.html%3Fproduct%3Dtezspire%26patientinfo%3Dy&amp;esheet=54001772&amp;newsitemid=20240519716817&amp;lan=en-US&amp;anchor=Patient+Information&amp;index=2&amp;md5=a580c9d86a7d9c937390c2b16649e58a\" rel=\"nofollow noopener\" shape=\"rect\"><b>Patient Information<\/b><\/a><b> and <\/b><a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.azpicentral.com%2Fpi.html%3Fproduct%3Dtezspire%26ifu%3Dy&amp;esheet=54001772&amp;newsitemid=20240519716817&amp;lan=en-US&amp;anchor=Instructions+for+Use&amp;index=3&amp;md5=84102ddedaad6edadf6fb9f7b5a9a1a7\" rel=\"nofollow noopener\" shape=\"rect\"><b>Instructions for Use<\/b><\/a><b>.<\/b><\/p>\n<p>\n<i>You may <\/i><a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fus-aereporting.astrazeneca.com%2Fadverse-events.html&amp;esheet=54001772&amp;newsitemid=20240519716817&amp;lan=en-US&amp;anchor=report+side+effects+related+to+AstraZeneca+products.&amp;index=4&amp;md5=78a44dd554ea327e390a8e9bb428dc15\" rel=\"nofollow noopener\" shape=\"rect\"><i>report side effects related to AstraZeneca products.<\/i><\/a><\/p>\n<p>\n<b>Notes<\/b><\/p>\n<p>\n<b>COURSE Phase IIa trial<\/b><\/p>\n<p>\nCOURSE 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.<sup>1,3<\/sup><\/p>\n<p>\n<b>Chronic Obstructive Pulmonary Disease (COPD)<\/b><\/p>\n<p>\nCOPD refers to a group of lung diseases, including chronic bronchitis and emphysema, that cause airflow blockage and breathing-related problems.<sup>4<\/sup> COPD is the third leading cause of death due to chronic disease and the sixth leading cause of mortality in the United States. COPD accounts for the majority of chronic lower respiratory mortality in the US at 150,000 deaths per year, and data suggests patients with COPD are, on average, 50 times more likely to die from their condition compared to those with asthma.<sup>5,6<\/sup><\/p>\n<p>\nThe lungs and heart are fundamentally linked and work together.<sup>7<\/sup> 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.<sup>8-11 <\/sup>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.<sup>8,12-14<\/sup><\/p>\n<p>\n<b>TEZSPIRE<\/b><\/p>\n<p>\nTEZSPIRE<i> <\/i>(tezepelumab) is being developed by AstraZeneca in collaboration with Amgen as a first-in-class human monoclonal antibody that inhibits the action of TSLP, a key epithelial cytokine that sits at the top of multiple inflammatory cascades and is critical in the initiation and persistence of allergic, eosinophilic and other types of airway inflammation associated with severe asthma, including airway hyperresponsiveness.<sup>15,16<\/sup> TEZSPIRE is approved in the US, EU, Japan and other countries for the treatment of severe asthma.<sup>17-19<\/sup><\/p>\n<p>\n<b>Amgen collaboration<\/b><\/p>\n<p>\nIn 2020, Amgen and AstraZeneca updated a 2012 collaboration agreement for TEZSPIRE. Both companies will continue to share costs and profits equally after payment by AstraZeneca of a mid single-digit inventor royalty to Amgen. AstraZeneca continues to lead development and Amgen continues to lead manufacturing. All aspects of the collaboration are under the oversight of joint governing bodies. Under the amended agreement, Amgen and AstraZeneca will jointly commercialize TEZSPIRE in North America. Amgen will record product sales in the US, with AZ recording its share of US profits as Collaboration Revenue. Outside of the US, AstraZeneca will record product sales, with Amgen recording profit share as Other\/Collaboration revenue.<\/p>\n<p>\nIn addition, we are also collaborating with AstraZeneca on AMG104\/AZD8630, an inhaled anti-TSLP compound currently in development for asthma. In November 2021, Amgen and AstraZeneca agreed to include AMG 104 \/ AZD8630 in the existing collaboration agreement. The companies share both costs and income, with no inventor royalty. AstraZeneca will be the development, manufacturing and commercial lead. AstraZeneca and Amgen will jointly commercialize AMG 104 \/ AZD8630 in North America, and AstraZeneca will distribute the product and book sales globally, including for the US.<\/p>\n<p>\n<b>Respiratory &amp; Immunology<\/b><\/p>\n<p>\nRespiratory &amp; Immunology, part of BioPharmaceuticals, is one of AstraZeneca\u2019s main disease areas and is a key growth driver for the Company.<\/p>\n<p>\nAstraZeneca is an established leader in respiratory care with a 50-year heritage. The Company aims to transform the treatment of asthma and COPD by focusing on earlier biology-led treatment, eliminating preventable asthma attacks, and removing COPD as a top-three leading cause of death. The Company\u2019s early respiratory research is focused on emerging science involving immune mechanisms, lung damage and abnormal cell-repair processes in disease and neuronal dysfunction.<\/p>\n<p>\nWith common pathways and underlying disease drivers across respiratory and immunology, AstraZeneca is following the science from chronic lung diseases to immunology-driven disease areas. The Company\u2019s growing presence in immunology is focused on five mid- to late-stage franchises with multi-disease potential, in areas including rheumatology (including systemic lupus erythematosus), dermatology, gastroenterology, and systemic eosinophilic-driven diseases. AstraZeneca\u2019s ambition in Respiratory &amp; Immunology is to achieve disease modification and durable remission for millions of patients worldwide.<\/p>\n<p>\n<b>About AstraZeneca<\/b><\/p>\n<p>\nAstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines in Oncology, Rare Diseases and BioPharmaceuticals, including Cardiovascular, Renal &amp; Metabolism, and Respiratory &amp; Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries, and its innovative medicines are used by millions of patients worldwide. For more information, please visit <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fnam05.safelinks.protection.outlook.com%2F%3Furl%3Dhttps%253A%252F%252Fwww.astrazeneca-us.com%252F%26data%3D02%257C01%257CJulia.Drabick%2540edelman.com%257C5e1836e411194a4a386408d84e890886%257Cb824bfb3918e43c2bb1cdcc1ba40a82b%257C0%257C0%257C637345697783430188%26sdata%3DlXKaI11uYzlIBvV6fwXLVhr7oZDfC048ruLXLReanJg%253D%26reserved%3D0&amp;esheet=54001772&amp;newsitemid=20240519716817&amp;lan=en-US&amp;anchor=www.astrazeneca-us.com&amp;index=5&amp;md5=7dfbebd69c04859a3ff66d96d1b22d19\" rel=\"nofollow noopener\" shape=\"rect\">www.astrazeneca-us.com<\/a> and follow us on social media <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fastrazeneca%2F&amp;esheet=54001772&amp;newsitemid=20240519716817&amp;lan=en-US&amp;anchor=%40AstraZeneca&amp;index=6&amp;md5=81f7220a2a7decc0f333beb6b90a0419\" rel=\"nofollow noopener\" shape=\"rect\">@AstraZeneca<\/a>.<\/p>\n<p>\n<b>References<\/b><\/p>\n<ol class=\"bwlistdecimal\">\n<li>\nSingh D, <i>et al<\/i>. Tezepelumab in adults with moderate to very severe chronic obstructive pulmonary disease (COPD): efficacy and safety from the phase 2a COURSE study. American Thoracic Society (ATS) 2024. May 2024.<\/li>\n<li>\nData on File REF-228444 \u2013 Blood Eosinophil Count in 65% COPD patients.<\/li>\n<li>\nClinicaltrials.gov. Tezepelumab COPD Exacerbation Study (COURSE) [Online]. Available at: <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT04039113&amp;esheet=54001772&amp;newsitemid=20240519716817&amp;lan=en-US&amp;anchor=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT04039113&amp;index=7&amp;md5=42f2e9455c5f106bcac3c750fbd780a9\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04039113<\/a>. [Last accessed: May 2024].<\/li>\n<li>\nGOLD. Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD), 2023. [Online]. Available at: <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fgoldcopd.org%2F&amp;esheet=54001772&amp;newsitemid=20240519716817&amp;lan=en-US&amp;anchor=http%3A%2F%2Fgoldcopd.org&amp;index=8&amp;md5=22a4b9e0eaf23db1553b3676c4dcad01\" rel=\"nofollow noopener\" shape=\"rect\">http:\/\/goldcopd.org<\/a>. [Last accessed: May 2024].<\/li>\n<li>\nCenters for Disease Control and Prevention (CDC). Leading Causes of Death. United States: CDC; January 17, 2024, <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.cdc.gov%2Fnchs%2Ffastats%2Fleading-causes-of-death.htm&amp;esheet=54001772&amp;newsitemid=20240519716817&amp;lan=en-US&amp;anchor=https%3A%2F%2Fwww.cdc.gov%2Fnchs%2Ffastats%2Fleading-causes-of-death.htm&amp;index=9&amp;md5=3508bf981affca520e6b75b24d4df1ab\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/www.cdc.gov\/nchs\/fastats\/leading-causes-of-death.htm<\/a>. [Last accessed: May 2024].<\/li>\n<li>\nNational Heart, Lung, and Blood Institute (NIH). Learn More Breathe Better: United States: NIH. <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.nhlbi.nih.gov%2FBreatheBetter&amp;esheet=54001772&amp;newsitemid=20240519716817&amp;lan=en-US&amp;anchor=https%3A%2F%2Fwww.nhlbi.nih.gov%2FBreatheBetter&amp;index=10&amp;md5=698abf9deef11d4be5836f4abbf163c2\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/www.nhlbi.nih.gov\/BreatheBetter<\/a>. [Last accessed: May 2024].<\/li>\n<li>\nAmerican Lung Association. <i>Your Heart and Lungs: The Ultimate Relationship<\/i> (2023) Available at: <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.lung.org%2Fblog%2Fheart-lung-relationship&amp;esheet=54001772&amp;newsitemid=20240519716817&amp;lan=en-US&amp;anchor=https%3A%2F%2Fwww.lung.org%2Fblog%2Fheart-lung-relationship&amp;index=11&amp;md5=9c2f4d122877afcaee17c31d799eee95\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/www.lung.org\/blog\/heart-lung-relationship<\/a>. [Last accessed: May 2024].<\/li>\n<li>\nHo TW, Tsai YJ, Ruan SY, <i>et al<\/i>. In-Hospital and One-Year Mortality and Their Predictors in Patients Hospitalized for First-Ever Chronic Obstructive Pulmonary Disease Exacerbations: A Nationwide Population-Based Study. <i>PLOS ONE<\/i>. 2014; 9 (12): e114866.<\/li>\n<li>\nDonaldson GC <i>et al<\/i>. Increased risk of myocardial infarction and stroke following exacerbation of COPD. <i>Chest<\/i>. 2010;137:1091-1097;9-2029.<\/li>\n<li>\nWatz H <i>et al<\/i>. Spirometric changes during exacerbations of COPD: A post hoc analysis of the WISDOM trial. <i>Respir Res<\/i>. 2018;19(1):251.<\/li>\n<li>\nSuissa S <i>et al<\/i>. Long-term natural history of chronic obstructive pulmonary disease: severe exacerbations and mortality. <i>Thorax. <\/i>2012;67(11):957-963.<\/li>\n<li>\nLindenauer PK, Dharmarajan K, Qin L, <i>et al<\/i>. Risk Trajectories of Readmission and Death in the First Year After Hospitalization for Chronic Obstructive Pulmonary Disease. <i>Am J Respir Crit Care Med<\/i>. 2018 Apr 15;197(8):1009-1017.<\/li>\n<li>\nGarc\u00eda-Sanz MT, C\u00e1nive-G\u00f3mez JC, Sen\u00edn-Rial L, <i>et al<\/i>. One-year and long-term mortality in patients hospitalized for chronic obstructive pulmonary disease. <i>J <\/i><i>Thorac Dis.<\/i> 2017; 9 (3): 636\u2010645. doi:10.21037\/jtd.2017.03.34.<\/li>\n<li>\nMannino DM <i>et al<\/i>. Global Initiative on Obstructive Lung Disease (GOLD) classification of lung disease and mortality: findings from the Atherosclerosis Risk in Communities (ARIC) study. <i>Respir Med<\/i>. 2006;100: pp.115-122.<\/li>\n<li>\nCorren J, <i>et al<\/i>. Tezepelumab in adults with uncontrolled asthma [supplementary appendix; updated April 18, 2019].<i> N Engl J Med<\/i>. 2017;377:936-946.<\/li>\n<li>\nVarricchi G, <i>et al<\/i>. Thymic Stromal Lymphopoietin Isoforms, Inflammatory Disorders, and Cancer. <i>Front Immunol<\/i>. 2018;9:1595.<\/li>\n<li>\nAstraZeneca plc. <i>Tezspire<\/i> (tezepelumab) approved in the US for severe asthma. Available at: <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.astrazeneca.com%2Fmedia-centre%2Fpress-releases%2F2021%2Ftezspire-tezepelumab-approved-in-the-us-for-severe-asthma.html&amp;esheet=54001772&amp;newsitemid=20240519716817&amp;lan=en-US&amp;anchor=https%3A%2F%2Fwww.astrazeneca.com%2Fmedia-centre%2Fpress-releases%2F2021%2Ftezspire-tezepelumab-approved-in-the-us-for-severe-asthma.html&amp;index=12&amp;md5=8449b9d7b2dccfc44b8cebae34a4badd\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/www.astrazeneca.com\/media-centre\/press-releases\/2021\/tezspire-tezepelumab-approved-in-the-us-for-severe-asthma.html<\/a>. [Last accessed: May 2024].<\/li>\n<li>\nAstraZeneca plc. <i>Tezspire<\/i> approved in the EU for the treatment of severe asthma. 2022. Available at: <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.astrazeneca.com%2Fcontent%2Fastraz%2Fmedia-centre%2Fpress-releases%2F2022%2Ftezspire-approved-in-the-eu-for-the-treatment-of-severe-asthma.html&amp;esheet=54001772&amp;newsitemid=20240519716817&amp;lan=en-US&amp;anchor=https%3A%2F%2Fwww.astrazeneca.com%2Fcontent%2Fastraz%2Fmedia-centre%2Fpress-releases%2F2022%2Ftezspire-approved-in-the-eu-for-the-treatment-of-severe-asthma.html&amp;index=13&amp;md5=749750fa30593bd582a0c98223b20149\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/www.astrazeneca.com\/content\/astraz\/media-centre\/press-releases\/2022\/tezspire-approved-in-the-eu-for-the-treatment-of-severe-asthma.html<\/a>. [Last accessed: May 2024].<\/li>\n<li>\nAstraZeneca plc. <i>Tezspire<\/i> approved in Japan for the treatment of severe asthma. Available at: <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.astrazeneca.com%2Fmedia-centre%2Fpress-releases%2F2022%2Ftezspire-approved-in-japan-for-severe-asthma.html&amp;esheet=54001772&amp;newsitemid=20240519716817&amp;lan=en-US&amp;anchor=https%3A%2F%2Fwww.astrazeneca.com%2Fmedia-centre%2Fpress-releases%2F2022%2Ftezspire-approved-in-japan-for-severe-asthma.html&amp;index=14&amp;md5=614bce9b81c473f0429650395d735b0c\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/www.astrazeneca.com\/media-centre\/press-releases\/2022\/tezspire-approved-in-japan-for-severe-asthma.html<\/a>. [Last accessed: May 2024].<\/li>\n<\/ol>\n<p>\n\u00a0<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\n<b>Media Inquiries<\/b><br \/>Brendan McEvoy +1 302 885 2677<br \/>\n<br \/>Jillian Gonzales +1 302 885 2677<\/p>\n<p>\nUS Media Mailbox: <a target=\"_blank\" href=\"&#109;&#x61;&#105;&#x6c;&#116;&#x6f;:&#x75;s&#x6d;e&#100;&#x69;&#97;&#x74;&#101;&#x61;&#109;&#x40;a&#x73;t&#x72;a&#122;&#x65;&#110;&#x65;&#99;&#x61;&#46;&#x63;o&#x6d;\" rel=\"nofollow noopener\" shape=\"rect\">&#x75;&#115;m&#x65;&#x64;&#105;a&#x74;&#101;a&#x6d;&#x40;&#97;s&#x74;&#114;a&#x7a;&#x65;&#110;e&#x63;&#x61;&#46;&#x63;&#x6f;&#109;<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Late-breaking results from the Phase IIa COURSE trial provide insight into TEZSPIRE\u2019s impact on COPD exacerbations in patients with a broad range of eosinophil levels WILMINGTON, Del.&#8211;(BUSINESS WIRE)&#8211;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 &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/new-data-presented-at-ats-2024-show-the-potential-of-tezspire-to-play-a-role-in-the-future-treatment-of-chronic-obstructive-pulmonary-disease\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-59393","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>New data presented at ATS 2024 show the potential of TEZSPIRE to play a role in the future treatment of chronic obstructive pulmonary disease - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/new-data-presented-at-ats-2024-show-the-potential-of-tezspire-to-play-a-role-in-the-future-treatment-of-chronic-obstructive-pulmonary-disease\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"New data presented at ATS 2024 show the potential of TEZSPIRE to play a role in the future treatment of chronic obstructive pulmonary disease - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"Late-breaking results from the Phase IIa COURSE trial provide insight into TEZSPIRE\u2019s impact on COPD exacerbations in patients with a broad range of eosinophil levels WILMINGTON, Del.&#8211;(BUSINESS WIRE)&#8211;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 ... 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