ATS 2022: Trelegy Ellipta Highlights

Chronic Obstructive Pulmonary Disease (COPD) is a condition which is characterized by airflow limitation, causing either airflow obstruction or a combination of diseases. The primary factor for COPD is tobacco smoking, but other environmental exposures such as biomass fuel exposure and air pollution may also contribute to the development of the disease. Besides exposure, intrinsic factors predispose individuals to develop COPD. These include genetic abnormalities, accelerated aging, and abnormal lung development. COPD is associated with other concomitant chronic diseases, which increase its morbidity and mortality. Its high mortality rate makes it imperative to have safer and efficacious treatment options available, which could ratchet down the disease-associated death rate.

Primarily, COPD care options are- Supportive care, Self-care, Therapy, Surgery, and Medication. Supportive care involves oxygen therapy while self-care aids in improving health through physical exercise and smoking cessation. Therapy comprises of pulmonary rehabilitation program which is an approach employed to teach the patient how to manage COPD symptoms to improve the quality of life. Additionally, surgery might involve bullectomy, lung volume reduction and lung transplant but are considered as less preferred alternatives. Under medications category, pharmacological therapies are included such as Muscarinic antagonists (Short-acting and Long-acting Muscarinic antagonists), Beta-2 adrenergic agonists (Short-acting and Long-acting beta agonists), Corticosteroids, and Phosphodiesterase-4 inhibitors administered by Oral or Inhalation route. These therapies may be administered in combination like dual therapy (LAMA/LABA or LABA/ICS) and triple therapy (LAMA/LABA/ICS). Triple therapy helps in improving lung function while providing remission in symptoms and exacerbation prevention. As per Global Initiative for Chronic Obstructive Lung Disease (GOLD), patients with recurrent exacerbations are recommended triple therapy instead of mono or dual therapy. The combination therapy may also be considered as a first-line of treatment for severe cases of COPD.

There are several brands available for triple therapy with different molecule combinations, some of which are- Breztri Aerosphere (glycopyrronium/ formoterol/ budesonide; from Astrazeneca), Trimbow (glycopyrronium/ formoterol/beclometasone; from Chiesi Farmaceutici) and Trelegy Ellipta (umeclidinium/vilanterol/fluticasone; from GlaxoSmithKline). Often, separate inhalers are also used to administer the medication in combination, such as Spiriva Handihaler (Tiotropium, from Boehringer Ingelheim) may be used along with Advair Diskus (salmetrol/fluticasone; from GlaxoSmithKline).

GSK, at the Americal Thoracic Society (ATS) conference, 2022, presented a comparative efficacy study of Fluticasone/Umeclidinium/Vilanterol (FF/UMEC/VI) versus other triple therapies for the treatment of COPD based on the literature review and network meta analysis. The study included single-inhaler as well as multiple inhalers. In this, a systematic literature review was performed on randomized control trials in adults aged 40 years or older with COPD. As an assessment parameter, mean difference in change from baseline at weeks 12 and 24 in trough forced expiratory volume in 1 s (FEV₁) was determined. Also, both fixed and random effects were used in this network meta analysis. After screening, 15 studies were identified as reporting FEV₁ data at 12 weeks and 5 studies at 24 weeks. Various comparator therapies taken into account were Umeclidinium+Fluticasone furoate/Vilanterol (UMEC+FF/VI), Tiotropium+Salmetrol/Fluticasone propionate (TIO+SAL/FP), Tiotropium+Budesonide/Formoterol (TIO+BUD/FOR), Budesonide/Glycopyrronium/Formoterol (BUD/GLY/FOR), etc. FF/UMEC/VI was found to be significantly more effective at increasing trough FEV1 (based on change from baseline) at 12 weeks than all triple comparators, apart from TIO (tiotropium) 18 + SAL/FP (salmeterol/fluticasone propionate), TIO 18 + BDP/FOR (beclomethasone dipropionate/formoterol), and UMEC+FF/VI. At 24 weeks, FF/UMEC/VI was also statistically significantly more effective at increasing trough FEV1 than all triple comparators in the network apart from UMEC+FF/VI. The findings of this study suggest positive long-term efficacy with single-inhaler of triple therapy comprising FF/UMEC/VI, showing significant and more effective improvement in trough FEV1 when compared with alternative therapies. Further studies are required for the validation of the results that would help in proving the Trelegy Ellipta as a better treatment option than most other COPD triple therapies.

According to DelveInsight, the overall COPD 7MM (the USA, EU5, Japan) market is estimated to grow positively during the period 2019-2032 and is reported to be at 12.3 Billion USD in 2021. Trelegy Ellipta contributes less than a tenth of the share of the overall market but is expected to grow in the forecast period.

For a more detailed analysis of the COPD market please reach us at https://www.delveinsight.com