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Three months of daily sublingual therapy cuts UTI recurrences by more than half

NEJM Evidence
Reuters Health - 03/02/2022 - A collection of inactivated bacteria, given sublingually for three months, can dramatically reduce the risk of urinary-tract infection in women who have recurrent episodes.

In a randomized test of 240 women in Spain and the United Kingdom, three months of daily administration of the experimental treatment, known as MV140, helped keep 56% of women free of UTIs for one year compared to 25% of the women treated with placebo, a significant difference.

A third group of women received the inactivated bacteria for six months, but the longer duration didn't seem to produce a significantly better outcome - 58% were UTI-free by the end of the study.

"Women receiving MV140 experienced a sustained improvement" in their quality of life, said the team, led by Dr. Maria-Fernanda Lorenzo-Gomez of University Hospital of Salamanca, in Spain.

Although the treatment is given every day for months, the researchers are characterizing it as a vaccine, specifically "a very novel mucosal-based vaccine that is administered under the tongue and the immunity is transferred to mucosal surfaces such as the vagina, urethra and most importantly, the bladder," co-author Dr. J. Curtis Nickel told Reuters Health by email. "It is a very slow vaccination process that is exceedingly safe and effective."

The number of registered adverse events was 48 with six months of therapy, 76 with three months, and 81 with placebo, and "we did not observe clinically concerning side effects," the researchers said.

The results are published in NEJM Evidence. Initial results were most recently released October 17 at the International Continence Society congress.

"The response has been overwhelmingly positive," said Dr. Nickel, professor of urology at Queens University in Kingston, Canada. "Physicians know that the management of recurrent UTI has been a major unmet need in women's health."

The treatment, available in some countries under a special access program, is sold by Madrid-based Inmunotek S.L. under the brand name Uromune. The company helped finance the test.

Roughly 5% to 10% of women suffer from recurrent UTIs, which means they have two or more infections during a six-month span or three or more infections over a year.

Antibiotic therapy to prevent recurrent infections impacts the microbiome, is not durable and leads to an increase in antibiotic resistance, Dr. Nickel said. "This approach should be less expensive, cause fewer side effects and lead to better antibiotic stewardship. In other words, it will be a game changer for women who suffer from recurrent UTIs."

In the new test, all the volunteers reported at least five uncomplicated cystitis episodes in the previous year. All continued to receive treatment under European Association of Urology guidelines, including antibiotic therapy.

MV140 treatment included inactivated strains of four bacteria species contained in a solution that was sprayed twice under the tongue each day.

During the nine-month follow-up, during which a third of the women were still taking the treatment for the first three months, the median number of UTI episodes was 3.0 in the placebo group and 0.0 in the two groups receiving MV140.

Forty-two of the 65 placebo recipients who completed the study had three or more UTIs. That compared to 12 of the 67 volunteers in the three-month group and nine of 61 in the six-month group.

The team estimated that 3.26 women needed to be treated for three months to prevent one UTI. In the six-month group, 3.03 needed to be treated.

Because six months of treatment did not appear to produce a significant additional benefit, "we do not think there is justification for extending the administration beyond 3 months," the researchers write.

In addition, "based on theory, experience and early trial and error, it appears that 3 months is the minimum period of vaccination required for most patients," said Dr. Nickel. "Although some patients see a decrease in UTIs very early, most require at least 3 months of active therapy for maximum benefit."

Even when it works, protection may not be permanent.

"Observational studies in Europe (specifically Spain) for a period of up to 2 years suggest that for some, revaccination is required after one year if the patient starts to have recurrent UTIs again," Dr. Nickel said.

"There is an ongoing safety study for patients in Europe who have received the vaccine under special access programs (called Named Patient Programs)," he added. "We have collected data on more than 20,000 patients and we note that some patients over the years have applied for revaccination. That would suggest that at least for some patients, the vaccination benefit may fade over time."

There are "very few treatment-related side effects, most of which are mild and resolve quickly," he said. "Only one of my personal patients (I have treated over 60 patients) stopped the vaccine because of a side effect. In that patient the side effect was vaccine anxiety."

SOURCE: https://bit.ly/3GnglXy NEJM Evidence, online January 21, 2022.

By Gene Emery

© 2023 The Author(s). Published by Medicom Medical Publishers.
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