Source:

Puente Maestu L, et al. ALERT: COPD. Presented at: European Respiratory Society International Congress; Sept. 5-8, 2021 (virtual meeting).

Disclosures: Puente Maestu reports receiving grants and research support from AstraZeneca, Chiesi, GlaxoSmithKline, Esteve and Menairini; receiving honoraria or consultant fees from AstraZeneca and GlaxoSmithKline; and participating in company-sponsored bureaus for Merck. Brusselle reports serving as a member of the scientific committee and board of directors for GINA and advisory boards for AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, MSD, Novartis, Sanofi and Teva, and receives lecture fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis, Sanofi and Teva. Andreas reports receiving grants/personal fees from Boehringer Ingelheim and personal fees from AstraZeneca, Chiesi, GlaxoSmithKline, Merini and Novartis.
September 08, 2021
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Sublingual bacterial immunotherapy to prevent COPD exacerbations shows promise

Source:

Puente Maestu L, et al. ALERT: COPD. Presented at: European Respiratory Society International Congress; Sept. 5-8, 2021 (virtual meeting).

Disclosures: Puente Maestu reports receiving grants and research support from AstraZeneca, Chiesi, GlaxoSmithKline, Esteve and Menairini; receiving honoraria or consultant fees from AstraZeneca and GlaxoSmithKline; and participating in company-sponsored bureaus for Merck. Brusselle reports serving as a member of the scientific committee and board of directors for GINA and advisory boards for AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, MSD, Novartis, Sanofi and Teva, and receives lecture fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis, Sanofi and Teva. Andreas reports receiving grants/personal fees from Boehringer Ingelheim and personal fees from AstraZeneca, Chiesi, GlaxoSmithKline, Merini and Novartis.
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Therapeutic immunomodulation with a sublingual mucosal bacterial vaccine in adults with COPD reduced the number and length of exacerbations and antibiotic use, researchers reported at the European Respiratory Society International Congress.

MV130 (Immunotek) is a whole-cell heat-inactivated mucosal immunotherapy that is based on whole inactivated bacteria. Sublingual immunization stimulates systemic and mucosal immune responses across a broad range of tissues and stimulates the growth rate of tissues, particularly in the upper and lower respiratory tracts, Luis Puente Maestu, MD, PhD, head of the department of pneumonology service at Gregorio Marañón University General Hospital, Madrid, said during a presentation.

COPD
Source: Adobe Stock.

“There is some evidence on mucosal bacterial vaccines. These are a class of medications whose potential benefit results from the stimulation of the monospecific component of the immune system,” Puente Maestu said.

The treatment schedule for MV130 is two puffs per day for 3 to 12 months.

Puente Maestu reported results of a randomized, double-blind, placebo-controlled, phase 3 trial that included 198 patients with COPD aged 35 to 85 years. All patients had three COPD exacerbations in the previous year or two exacerbations with one hospitalization. Patients were randomly assigned to receive MV130 (n = 97) or placebo (n = 101) daily for 12 months, with follow-up out to 18 months. The trial was conducted at seven hospitals in Spain.

The primary outcome was the number of COPD exacerbations over 18 months. Secondary outcomes included safety, decrease in severity of COPD exacerbations, health care resource use, quality of life and immunological parameters.

After 18 months, total COPD exacerbations were reduced by 30% in the MV130 group vs. placebo. Researchers observed a median of two COPD exacerbations among patients assigned MV130 compared with three exacerbations among those treated with placebo (P < .01). There was a stronger MV130 treatment effect among patients with severe and moderate exacerbations, Puente Maestu said.

MV130 reduced the duration of COPD exacerbations by 50% compared with placebo (median number of days, 10 vs. 20; P < .01) and reduced antibiotic use by 60% (median number of days antibiotics used, 12 vs. 29; P < .01) compared with placebo.

According to Puente Maestu, there were 115 reported adverse effects or first events among patients assigned MV130 compared with 140 among those assigned placebo. Two drug-related adverse events occurred; one was a nonserious urticaria systemic reaction in the placebo group and the other was nonserious cutaneous itching as a systemic reaction in the MV130 group, he said.

“These are very impressive results,” Guy Brusselle, MD, PhD, with the department of respiratory medicine at Ghent University Hospital, Belgium, said during a discussion of the results. “My question, of course, is: Is this too good to be true?”

Brusselle referenced a study recently published in the American Journal of Respiratory and Critical Care Medicine by Nieto and colleagues that evaluated MV130 for prevention of recurrent wheezing in children. Results of this randomized, double-blind, placebo-controlled trial demonstrated that MV130 was safe and effective for prevention of recurrent wheezing attacks in children.

Taken together, “can we use the same MV130 for these two totally different patient populations,” Bruselles asked.

For a second study presented during the same session, Stefan Andreas, MD, with the department of cardiology and pneumonology at University Medical Center Göttingen, Germany, evaluated whether vaccination against non-typeable Haemophilus influenzae (NTHi) and Moraxella catarrhalis (Mcat) would reduce exacerbations in patients with COPD.

The randomized, placebo-controlled, phase 2b trial enrolled 606 adults with COPD and at least one moderate or severe acute exacerbation of COPD in the prior year. Patients were recruited from November 2017 to November 2018 at 67 centers worldwide. Patients were randomly assigned to two intramuscular injections of the NTHi-Mcat vaccine (GlaxoSmithKline) or placebo, given 60 days apart.

“This is the first randomized controlled trial investigating vaccination against these two specific bacteria in COPD,” Andreas said. The vaccine created a strong immune response against these two bacteria in previous small studies, including one conducted in elderly smokers, he said.

The primary objective of reducing the number of moderate and severe acute exacerbations of COPD within 1 year was not met (P = .8157), nor was the number of mild acute exacerbations of COPD (P = .756). The secondary objective of reducing the number of severe exacerbations, which were much less common, trended toward a reduction with the vaccine (P = .075), Andreas said.

No safety concerns were identified. Fewer reports of COPD leading to hospitalization occurred in the vaccine group compared with the placebo group.

The candidate vaccine induced antigen-specific immune response, he said.

“The primary efficacy objective of reducing the frequency of moderate and severe acute exacerbations was not met. However, immunogenicity and possible reduction in the frequency of severe acute exacerbations of COPD in the vaccine group may encourage further investigations, as does the reduction in mortality (one vs. 10),” Andreas said.

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