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Glycopyrronium Bromide (Seebri® Breezhaler) for Maintenance Treatment of Adults with Stable COPD

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Glycopyrronium Bromide (Seebri® Breezhaler) for Maintenance Treatment of Adults with Stable COPD New Medicines Committee Briefing Updated July 2017 Glycopyrronium bromide (Seebri® Breezhaler) for maintenance treatment of adults with stable COPD Primary Care Seebri® Breezhaler is to be reviewed for use within: Secondary Care Summary: Glycopyrronium (Seebri® Breezhaler) dry-powder inhaler is a once-daily, long-acting muscarinic antagonist (LAMA). Seebri® was launched in the UK in November 2012, as a maintenance bronchodilator for treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD). Seebri® was previously reviewed in July 2013 and the Area Prescribing Committee (APC) concluded that Seebri® should not be included within the North Staffordshire Joint Formulary as at that time there were no direct comparator trials with other active bronchodilators, lack of long term safety data and little local experience of its use. There is no updated guidance available from NICE, SMC, RDTC, MTRAC or Cochrane since July 2013 but there are now two new clinical trials (GLOW5 and GEM3 study)1,2 that has compared Seebri with active bronchodilators The GLOW5 study – a randomised double blinded evaluation of the efficacy and safety of glycopyrronium versus tiotropium demonstrated similar efficacy and safety over 12 weeks, with glycopyrronium having a faster onset of action on day 1 in comparison to tiotropium in patients with moderate-to-severe COPD. The GEM3 study – a randomised double blinded parallel study of the long term safety of glycopyrronium in comparison to indacaterol demonstrated a similar safety profile over 52 weeks in patients with moderate-to-severe COPD. Seebri® is a black triangle drug ( ) and is monitored intensively by the MHRA. 1 Chapman K, Beeh K, Beier J et al. A blinded evaluation of the efficacy and safety of glycopyrronium, a once-daily long-acting muscarinic antagonist, versus tiotropium, in patients with COPD: the GLOW5 study. BMC pulmonary medicine 2014; 14; 4 2 Mahler D, Gifford A, Satti A et al. Long-term safety of glycopyrrolate: A randomized study in patients with moderate- to-severe COPD (GEM3) with moderate-to-severe COPD (GEM3)/ Respiratory Medicines 2016; 115; 39-45 1 | P a g e Formulary application Consultant submitting application: Dr Imran Hussain (Respiratory Consultant) Clinical Director supporting application: Dr Anthony Cadwgan (Clinical Director) Dr Hussain has requested for Seebri® to be re-considered for inclusion in the North Staffordshire Joint Formulary for the maintenance treatment of adult patients with stable COPD. Seebri® was previously reviewed in July 2013 and not approved by the Area Prescribing Committee (APC) for inclusion within the North Staffordshire Joint Formulary as at that time there were no direct comparator trials with other active bronchodilators, lack of long term safety data and little local experience of its use. Dr Hussain states that there is now greater experience with Seebri® within the respiratory team as well as long term safety and tolerability data compared to other bronchodilators. Dr Hussain noted that there is no cost difference between Seebri® and the alternative treatments included on the formulary. He also stated the following as potential benefits from having Seebri® on the formulary: if Ultibro® is accepted onto the formulary, then this would help in terms of device familiarity for patients The drug has a faster rate of onset compared to the other LAMAs (tiotropium and aclidinium), which may improve patient functioning faster The device requires a lower inspiratory flow rate compared to the Ellipta® and Genuair® devices which increases the likelihood that patients will be able to use the device as their disease progresses. This will also provide an option for trialling patients on this device prior to consideration of escalation to a combination inhaler or nebuliser. He intends that Seebri® be initiated by both hospital and primary care prescribers. Current formulary status The North Staffordshire Joint Formulary currently lists the following agents. 3.1.2 Antimuscarinic Bronchodilators At a Incruse Ellipta® (Umeclidinium) For use in COPD only glance guide: Stable COPD At a glance guide: For use in COPD with end of day deterioration Eklira Genuair® (Aclidinium) Stable COPD MTRAC At a Ipratropium glance guide: Stable COPD For use in COPD only Braltus Zonda® (Tiotropium) 10 microgram per delivered dose Spiriva Respimat® 2 For use in Asthma only MTRAC (Tiotropium) Seebri® Breezhaler (Glycopyrronium Not approved for inclusion in the North Staffordshire Joint Medicines Review bromide) Formulary Verdict Sheet 2 | P a g e Guidance and Evidence Summary There is no updated guidance available from NICE, SMC, RDTC, MTRAC or Cochrane since July 2013 but there are now two new clinical trials (GLOW5 and GEM3 study)3,4 that have compared Seebri® with active bronchodilators. Recent trials post NMC review 2013 GLOW53 study: A blinded evaluation of the efficacy and safety of glycopyrronium, a once-daily long-acting muscarinic antagonist, versus tiotropium, in patients with COPD: the GLOW5 study The GLOW5 study - a randomised, blinded, double-dummy study of 657 patients - compared glycopyrronium 50micrograms once daily to tiotropium 18micrograms once daily for 12 weeks. The primary objective was to demonstrate non-inferiority of glycopyrronium compared to blinded tiotropium for trough FEV1 after 12 weeks. A key secondary objective was to demonstrate superiority of glycopyrronium compared to tiotropium. Other secondary objectives included the effect of glycopyrronium versus tiotropium on other measures of lung function including forced vital capacity (FVC), peak FEV1, FEV1 area under the curve from 0-4hours (AUC0-4h), and inspiratory capacity (IC); and the effect of glycopyrronium verses tiotropium on breathlessness measured using the Transition Dyspnoea Index (TDI) focal score, health status according to the St George’s Respiratory questionnaire (SGRQ) total score, daily rescue medication use, COPD exacerbations and COPD symptoms over 12 weeks of treatment. GLOW5 enrolled patients ≥40 years with stable moderate to severe COPD (post-bronchodilator FEV1 30- 79% predicted and FEV1/FVC <0.7), who were current or ex-smokers with at least a 10 pack-year history of smoking. The main exclusion criteria was a respiratory tract infection within 4 weeks or COPD exacerbations requiring treatment within 6 weeks prior to screening, concomitant respiratory diseases or clinically significant cardiovascular disease. Long-acting bronchodilators were discontinued but inhaled corticosteroids (ICS) and short-acting β2-agonists could be continued throughout the study – approximately half of the patients in each group were using ICS at baseline. 96% of patients completed the study. The number of patients who discontinued was similar in both groups. Spirometry: Glycopyrronium met the criteria for non-inferiority to tiotropium for improvement in trough FEV1 after 12 weeks of treatment (least squares means [LSM] treatment difference 0ml, 95% CI: -32, 31ml, p<0.001). At week 12, peak FEV1, FEV1 at all time points from 0-4h and 24h and FEV1 AUC0-4h was comparable between glycopyrronium and tiotropium. No statistically significant difference was observed between the two treatment groups. Glycopyrronium demonstrated rapid bronchodilation following the first dose on day 1, with significantly higher FEV1 at all time points from 0-4h post-dose versus tiotropium (all p<0.001). 3 Chapman K, Beeh K, Beier J et al. A blinded evaluation of the efficacy and safety of glycopyrronium, a once-daily long-acting muscarinic antagonist, versus tiotropium, in patients with COPD: the GLOW5 study. BMC pulmonary medicine 2014; 14; 4 3 | P a g e Symptoms, health status and exacerbations: Glycopyrronium demonstrated comparable improvements to tiotropium in TDI focal score, SGRQ total score, rescue medication use and the rate of COPD exacerbations. A similar proportion of patients in both groups experienced a clinically meaningful improvement in TDI focal score (≥1 point) [odds ratio 1.06; p = 0.753] and clinically meaningful improvement in SGRQ total score (≥ 4 point reduction) [OR 1.11; p = 0.575]. The number of patients who experienced a moderate or severe COPD exacerbation was similar in both groups (9.7% with glycopyrronium versus 7.5% with tiotropium). Patients on glycopyrronium also had a significantly lower total COPD symptom score versus patients on tiotropium after 12 weeks (treatment difference -0.3, p = 0.035), although the criteria for clinical significance was not defined for this parameter. The use of rescue medication in the two treatment groups was comparable. Safety: Adverse events were reported by a similar percentage of patients receiving glycopyrronium (40.4%) and tiotropium (40.6%). The most frequently reported adverse event was COPD worsening (17.6% in the tiotropium group compared to 15.3% in the glycopyrronium group). Serious adverse events and adverse events leading to discontinuation occurred in a comparable number of patients in both groups. Limitations: The trial was conducted over 12 weeks – a longer timeframe would normally be required for assessment of drug efficacy on outcomes such as exacerbation rates. GEM3 Study5: Long term safety of glycopyrrolate: A randomised study in patients with moderate to severe COPD (GEM3) Mahler et al conducted a multi-centre double-blind study comparing glycopyrronium 15.6micrograms twice daily to indacaterol 75micrograms once daily, both delivered via the Neohaler® device, over 52 weeks (n=511).
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