After its approval by the FDA, no new safety findings were reported on weekly dosing of the biologic.
Koremasa Hayama, MD, PhD
A recent investigation from Japan into the monoclonal antibody adalimumab found that the biologic was a well-tolerated and effective treatment for patients affected by hidradenitis suppurativa.
Adalimumab had previously been approved as a treatment for the disease in Europe, the US, and Japan. Though phase 3 trials of adalimumab had proven effective for the management of hidradenitis suppurativa, no new safety findings were reported on weekly dosing of the biologic after its approval.
Investigators led by Koremasa Hayama, MD, PhD, Nihon University School of Medicine, evaluated the long-term safety and efficacy of adalimumab for the treatment of moderate-to-severe hidradenitis suppurativa in Japanese patients.
From April 23, 2019 to February 14, 2020, investigators collected patient data from participating physicians who were in charge of the study using case report forms, which were later submitted to the study sponsor at the end of the observation period using an internet-based electronic data capture system.
Eligible patients included those who were prescribed adalimumab for the first time by their treating physicians. In keeping with routine clinical practice, patients were eligible for adalimumab treatment only after all existing treatment options proved ineffective.
Adalimumab was administered at 160 mg for the first dose, followed by a 80 mg dose after 2 weeks. The third dose (4 weeks after the initial dose) and all subsequent doses were 40 mg every week or 80 mg every 2 weeks.
The observation period for the study was 52 weeks from the start of adalimumab treatment. If treatment discontinued before 52 weeks, the occurrence of adverse events (AE) was observed up to 70 days after the final dose.
Regarding patient information, investigators collected data on age, sex, bodyweight, disease period, severity of disease, family history of hidradenitis suppurativa, history of smoking, affected site, medical history, previous and concomitant treatment for hidradenitis suppurativa, concomitant drugs for diseases other than hidradenitis suppurativa, adverse events, and effectiveness evaluation.
The primary endpoint was defined safety and included the number and percentage of patients who reported any serious infection, any adverse drug reaction (ADR), any infection, and any safety event of special interest during the study.
A total of 83 patients were included in the study, with 65 (78.3%) being male with the mean age being 42 years old.
Investigators observed that among the 83 patients, 61.4% had Hurley stage III disease with 39.8% citing a disease duration ≥10 years, and 7.2% had a family history of hidradenitis suppurativa.
The most common affected sites from the disease were the axilla (60.2%), buttocks (59.0%), and the inguinal and femoral regions (47.0%).
The most common comorbidities reported were diabetes mellitus, hypertension, and chronic kidney disease. Additionally, 57.8% of all participants had a comorbidity.
No patient reported a serious infection or any safety event of special interest. However, 1 patient died from a serious adverse event of cardiac failure unrelated to adalimumab.
Promisingly, 57.4% of patients achieved an appropriate clinical response and significant reductions from baseline in skin pain, DLQI (both p < 0.0001), and CRP (p = 0.0029).
“The safety and effectiveness data reported here are consistent with the data from previous clinical trials, and no new safety concerns were observed in patients with HS in real-world clinical practice,” the team wrote.
The study, "Real-world safety and effectiveness of adalimumab in patients with hidradenitis suppurativa: 12-week interim analysis of post-marketing surveillance in Japan," was published online in the Journal of Dermatology.