Strong Long-Term Trial Data for Adalimumab Observed for HS Patients in Real World Settings

Article

In the results of this final analysis, the hidradenitis suppurativa drug was found to be well tolerated in patients regardless of either differing demographics or clinical characteristics.

Koremasa Hayama, MD, PhD

Credit: ResearchGate

Koremasa Hayama, MD, PhD

Credit: ResearchGate

Long-term treatment of hidradenitis suppurativa (HS) patients with adalimumab is both well-tolerated and effective in real-world clinical settings, according to recent findings.1

These findings resulted from a study out of Japan examining the human monoclonal antibody’s use on tumor necrosis factor-α, as the drug has been approved in Japan for HS treatment.

The study was conducted given the lack of long-term data on the efficacy and safety of adalimumab in HS patients from Japan in a real-world clinical setting, and the research was authored by Koremasa Hayama, MD, PhD, from the Nihon University School of Medicine in Japan.

“Here we report the final analysis of the PMS study and evaluate the 52-week safety and effectiveness results of adalimumab treatment in patients with HS in real-world clinical practice in Japan,” Hayama and colleagues wrote.

Background and Findings

The investigators conducted the study at 65 different centers across Japan from March of 2019 to May of 2021. It was a prospective, open-label observational study, and the methodology was previously outlined in a 12-week interim report.2

Patient enrollment began in April of 2019 and concluded in February of 2020. The registration process involved a centralized method, and the physicians in charge of the study completed a case report form, which was then submitted through an internet-based electronic data capture system.

The study included patients diagnosed with HS who were newly prescribed adalimumab by their doctors. Patients who had previously received adalimumab and declined to participate were excluded, and the dosage and administration of the drug followed the instructions provided in the package insert.

The research team’s treatment consisted of an initial dose of 160 mg, followed then by a second dose of 80 mg after two weeks, and subsequent doses of 40 mg every week or 80 mg every 2 weeks. The team monitored the participants for 52 weeks from the start of adalimumab treatment, with additional observation for adverse events up to 70 days following treatment discontinuation.

The survey they used included various items such as patient characteristics, adalimumab treatment details, medical history, prior and concomitant therapies, seriousness and occurence of adverse events, and effectiveness evaluation.

The investigators’ safety analysis included 83 out of 84 registered patients. Adverse drug reactions (ADRs) were reported by 12% of study participants, with 2 serious ADRs, including a single person with a severe infection.

Other notable safety events included liver disorder and dermatitis psoriasiform. Most patients with ADRs were recovering or had recovered, except for 1 individual who unfortunately died due to a serious ADR of liver disorder.

In terms of effectiveness, the research team noted that 55.4% of patients achieved HS clinical response (HiSCR) at 12 weeks of treatment. This percentage was also found to have increased to 60.5% at 24 weeks and 62.8% at 52 weeks.

Additionally, substantial improvements were also observed in C-reactive protein (CRP) levels, skin pain, and Dermatology Life Quality Index (DLQI) scores at all time points compared to baseline. Overall, long-term adalimumab treatment was shown to be well-tolerated and effective.

“Unlike clinical trials, which have strict eligibility criteria and exclude patients who are using concomitant medications or have mild disease, the patients assessed in this study better reflect the real patient population in Japan,” they wrote.

References

  1. Hayashi N, Hayama K, Takahashi K, Kurokawa I, Okazaki M, Kashiwagi T, et al. Real-world safety and effectiveness of adalimumab in patients with hidradenitis suppurativa: A 52-week analysis of a postmarketing surveillance study in Japan. J Dermatol. 2023; 00: 1–11. https://doi.org/10.1111/1346-8138.16835.
  2. Hayashi N, Hayama K, Takahashi K, Kurokawa I, Okazaki M, Kashiwagi T, et al. Real-world safety and effectiveness of adalimumab in patients with hidradenitis suppurativa: 12-week interim analysis of post-marketing surveillance in Japan. J Dermatol. 2022; 49: 411– 21.
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