Boehringer’s Spiolto tops Seretide in head-to-head COPD trial

Boehringer Ingelheim’s recently-approved Spiolto is more effective than GlaxoSmithKline’s Seretide/Advair in improving lung function in patients with chronic obstructive pulmonary disease (COPD), according to new data.

The results of the ENERGITO study, presented for the first time at the European Respiratory Society (ERS) congress in Amsterdam this week, are among the first data to show that a combination of a long-acting muscarinic antagonist (LAMA) and long-acting beta agonist (LABA) is more effective than a LABA combined with an inhaled corticosteroid (ICS) in moderate-to-severe COPD.

In the study Spiolto – which combines tiotropium, the active ingredient in Boehringer’s LAMA drug Spiriva with LABA olodaterol – demonstrated a 42 percent improved in a key measure of lung function compared to Seretide (salmeterol/fluticasone propionate).

Boehringer notes that despite the known side effects of ICS and guidelines that recommend they be used only in patients with severe COPD, ICS-based therapies are still widely used “across all stages of COPD.”

The results from ENERGITO add to the data from the large-scale WISDOM trial, which was reported at last year’s ERS and showed that withdrawing the steroid component from triple therapy with LAMA/LABA/ICS had no impact on exacerbation rates in COPD.

That trial was not without its detractors – some suggested that it was flawed for including patients who did not really need triple therapy, so withdrawing the ICS component was less likely to show an impact. Nevertheless, there seems to be a general shift towards minimising ICS use in COPD.

“ICS-containing therapies certainly have a role in the management of COPD, but questions remain regarding when to use these treatments,” said Professor Kai-Michael Beeh of the Insaf GmbH Institut für Atemwegs-forschung in Germany.

He noted that the ENERGITO results suggest steroid-containing therapies “may only be required in a population of patients with more severe stages of the disease and frequent exacerbations.”

Taken together, the two trials should accelerate the uptake of LAMA/LABA combinations, which along with Spiolto include GSK’s Anoro (umeclidinium bromide/vilanterol), Novartis’ Ultibro (glycopyrronium/indacaterol) and AstraZeneca’s Duaklir (aclidinium bromide/formoterol).

On the other hand, the results suggest GSK will have its work cut out building market share for Breo (fluticasone furoate/vilanterol), its follow-up to Seretide which recently failed to show an improvement in survival in a large-scale COPD study. The latter is facing generic competition in some markets already and could see the first direct rival reach the US market either next year or in 2017.

Like Seretide, Breo is also approved for asthma so COPD is only part of the story, but anything that discourages its use in COPD will make it harder for GSK to turn around the fortunes of its embattled respiratory unit.

The prevalence of COPD continues to rise as the global population ages and people continue to engage in risky activities such as smoking, with some estimates predicting that it will become the third leading cause of death worldwide by 2030.

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