Physician Views: FirstWord is polling pulmonologists and PCPs to ask if Novartis' FLAME data will fuel LABA/LAMA use in COPD

To coincide with the upcoming publication of an update to our COPD Therapy Trends report, FirstWord is polling US and EU5-based pulmonologists and primary care practitioners (PCPs) about the potential impact of data from Novartis' FLAME study, which was released earlier this year and presented at the European Respiratory Society (ERS) International Congress last month.

In the trial, a once-daily version of Novartis' LABA/LAMA combination Ultibro Breezhaler demonstrated a significant benefit over GlaxoSmithKline's twice-daily LABA/ICS combination Seretide/Advair in reducing chronic obstructive pulmonary disease (COPD) exacerbation rates, irrespective of patient severity and age, over the course of a year in those with a history of at least one exacerbation in the previous 12 months. In FLAME, Ultibro also proved superior to Seretide/Advair against a number of secondary endpoints.

To what extent data from FLAME will impact prescribing habits in COPD is somewhat unclear. Critically, for example, Novartis' once-daily version of Ultibro is not available in the US market (although analysts expect the company to provide an update on whether it will seek to replicate the FLAME data in an additional US-focused trial in by the end of 2016).

Furthermore, the treatment paradigm for COPD is expected to evolve from 2017 onwards if GlaxoSmithKline successfully secures approval for the first 'closed triple' combination therapy (combining a LABA/LAMA and ICS). See Physician Views Poll Results: 237 pulmonologists and primary care practitioners provide feedback on how they will use triple therapy combinations for the treatment of COPD.

Key opinion leaders recently interviewed by FirstWord expect triple combination therapy to prove popular with physicians, but note recent Phase III data presented by both GlaxoSmithKline and Chiesi compares their triple combinations to ICS/LABA pairings. Data comparing them to LABA/LAMA combinations could prove critical in driving the rate of adoption, they add, particularly if results from the FLAME trial have a positive effect on LABA/LAMA usage.

In the meantime, FirstWord's latest Physician Views poll seeks to provide further clarity on how pulmonologists and PCPs are using LABA/LAMA combinations in current practice. Specifically we are asking them…

How comfortable are you switching COPD patients from ICS/LABA to LABA/LAMA therapy?

Not comfortable

Marginally comfortable

Moderately comfortable

Very comfortable

Extremely comfortable

In the 52-week FLAME study, Ultibro Breezhaler, an inhaled, once-daily combined LABA/LAMA met its primary endpoint of non-inferiority versus Seretide/Advair (twice-daily LABA/ICS). It also demonstrated superiority in reducing the annual rate of all COPD exacerbations which was 11% lower in the Ultibro arm (3.59 vs 4.03, p=0.003) and superiority across further exacerbation and other endpoints, irrespective of disease severity or eosinophil levels.

Ultibro patients showed a longer time to first exacerbation than those on Advair (71 days vs 51 days); a 17% lower annual rate of moderate or severe COPD exacerbations; a longer time to first moderate-to-severe exacerbation (127 days vs 87 days) and 19% lower risk of first severe exacerbation. The annual rate of severe COPD exacerbations (0.15 vs 0.17) was not significantly different.

Do you expect these data to have a meaningful impact on clinical practice for the treatment of COPD? (i.e. in switching patients to/starting patients on LABA/LAMA therapy)

No

Yes – marginal impact

Yes – moderate impact

Yes – significant impact

Yes – very significant impact

Do you think these, and any additional (with similar results), data supporting use of LABA/LAMA therapy will limit the adoption of 'closed triple' therapies (i.e. LABA/LAMA/ICS) once available?

No

Yes – marginally

Yes – moderately

Yes – significantly

Yes – very significantly 

Do you think these data increase the importance of future Phase III data readouts showing whether closed triple combinations reduce the annual rate of moderate to severe exacerbations compared with LABA/LAMA combinations (i.e. GlaxoSmithKline's IMPACT study)?

No

Yes – marginally

Yes – moderately

Yes – significant

Yes – very significantly

How comfortable are you with the idea of limiting the use of ICS therapy to COPD patients who test positive high blood eosinophil count – i.e. prescribing those patients a triple LABA/LAMA/ICS combination versus a LABA/LAMA combination?

Not comfortable

Marginally comfortable

Moderately comfortable

Very comfortable

Extremely comfortable

Results and related analysis will be published for FirstWord Pharma PLUS subscribers to read, with the opportunity for non-FirstWord Pharma PLUS subscribers to purchase these findings. To be notified when poll results and analysis become available, please click here.

As always, FirstWord would very much like to receive your feedback and suggestions. Note: FirstWord Polls are powered by MedePolls, a fast-turnaround service to conduct instant polls of up to five questions with guaranteed samples that include physicians from dozens of specialties and over 100 markets. To conduct this poll with a different audience, or an entirely different poll, contact us at info@firstwordpharma.com

To read more Physician Views articles, click here.