The results of two studies on the efficacy and safety of bimekizumab in the treatment of adult patients suffering from are positive hidradenitis suppurativa (Hs) moderate to severe. Data from Phase 3 studies (Be Heard I and Be Heard II) show that the drug achieved clinically meaningful and consistent improvements in Hs manifestations and symptoms at week 16 compared to placebo – in some cases as early as the first dose and at the fourth week – which were maintained until week 48. The pharmaceutical company UCB announces it during a ‘late-breaking’ presentation, on the occasion of the annual congress of the American Academy of Dermatology (AAD) 2023 where other abstracts were also presented with results from studies in psoriasis and psoriatic arthritis.
Bimekizumab – explains the pharmaceutical company in a note – is a humanized monoclonal IgG1 antibody designed to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), two “key” cytokines in inflammatory processes. Clinical responses with bimekizumab were seen as early as the first dose, with some patients achieving HiSCR50 (Hidradenitis Suppurativa Clinical Response 50) at week 4. Hidradenitis suppurativa is a chronic, recurring, painful and debilitating inflammatory skin disease. The main symptoms are lumps, abscesses and pus-releasing fistulas, typically found in the armpits, groin and buttocks. People with Hs experience flare-ups of the disease and severe pain, which can have a very negative impact on quality of life.
“Hydradenitis suppurativa is a chronic and debilitating skin disease for which there is only one approved treatment available today,” said lead investigator of the studies, Alexa B. Kimball, of Beth Israel Deaconess Medical Center and professor of dermatology at the Harvard Medical School of Boston – Treatment of moderate to severe cases with bimekizumab has shown promising results in Phase 3 trials, with sustained improvement after one year.” The studies – involving 505 patients in Be Heard I and 509 in Be Heard II – evaluated two dosing regimens of bimekizumab – 320 mg every two weeks (Q2W) and 320 mg every four weeks (Q4W) – comparing them to treatment with the placebo over the initial 16 weeks; patients then continued treatment with the drug for an additional 32-week maintenance period.
Data presented at AAD 2023 show that: A significantly higher proportion of patients treated with bimekizumab (Q2W) achieved HiSCR50 (Hidradenitis Suppurativa Clinical Response 50, primary endpoint) at week 16 – 47.8% vs. 28.7% and 52.0% vs. 32.2%; a greater proportion of treated patients (Q4W) than placebo achieved the HiSCR50 at week 16 (45.3% vs. 28.7% and 53.8% vs. 32.2%, respectively); treated patients demonstrated high levels of clinical response, with a higher rate of HiSCR75 response than placebo, at week 16, a key secondary endpoint, with statistical significance with both dosing regimens in Be Heard II, and with Q2W dosing in Be Heard I.
Patients treated with bimekizumab reported an improvement in health-related quality of life (change from baseline in Dermatology Quality of Life Index) compared with placebo at week 16 with both regimens. Clinical responses (HiSCR50 and HiSCR75) were maintained with continued treatment with bimekizumab: over 75% of patients achieved HiSCR50 and over 55% achieved HiSCR75 at week 48. “These results – says Emmanuel Caeymaex, Executive Vicepresident, Head of PV Immunology & US Solutions of UCB – highlight the significant clinical results obtained, identifying as a target interlukine 17F in addition to 17A. We are now focused on the next steps regarding the authorization process of bimekizumab in hidradenitis suppurativa with the Regulators, expected by the end of the year”.
The treatment safety profile in the 2 studies was consistent with previous studies, with no new safety concerns being observed. The most common adverse events were oral candidiasis, headache, and diarrhea. UCB – concludes the note – expects to submit to the European Medicines Agency (EMA) the application for approval of bimekizumab in moderate to severe HS starting in the third quarter of 2023. In the United States, the efficacy and safety has not been established for any indication and the drug is not yet approved by the Food and Drug Administration (Fda). In the European Union and Great Britain, bimekizumab has been approved for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. The pharmaceutical company is testing bimekizumab in HS, but its efficacy and safety for this disease have not yet been established, and the drug has not been approved for this indication by any regulatory authority globally.
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