Long-term use of adalimumab is an effective and safe treatment for moderate to severe hidradenitis suppurativa (HS), study data published in the Journal of Dermatology suggests.
The study was an open-label phase 3 trial that included Japanese patients with moderate to severe HS from multiple centers. A total of 15 patients in the study received 160 mg subcutaneous adalimumab at week 0, 80 mg at week 2, and 40 mg at week 4 and thereafter. After 52 weeks, patients were able to receive 80 mg adalimumab every other week or remain on 40 mg weekly.
Achievement of HS Clinical response (HiSCR) at week 24 comprised the primary endpoint. Secondary endpoints were total abscess and inflammatory nodule (AN) count, 30% or more and 1 unit or more reduction in Patient’s Global Assessment of Skin Pain Numeric Rating Scale (NRS30), modified Sartorius score, and quality of life (QoL).
After 12 weeks, approximately 86.7% of patients achieved HiSCR. The achievement of HiSCR was sustained through week 52 in 66.7% of participants. At week 12, improvements were observed in 73.3% patients who achieved an AN count of 0 to 2, which was generally maintained through week 52 and up to 124 weeks. The NRS30 response rates were 33.3% at week 2, 66.7% at week 12, and 55.6% at week 52. These responses were also maintained for 124 weeks. Patients treated with adalimumab also had improvements in several QoL assessments at up to 52 weeks.
No new safety findings were reported for the 40 mg weekly dose. Also, the investigators reported no differences between patients who switched to 80 mg every other week vs patients who remained on the weekly 40 mg dose in terms of safety.
Limitations of the study included its open-label design, the lack of a placebo group or comparator arm, as well as the small number of participants.
The QoL findings from this study are particularly notable, according to the researchers, as “QoL assessment scores for patients with HS are often worse than QoL scores for patients with other dermatological conditions, malignant neoplasms, Parkinson’s disease, and stroke.”
Disclosure: This clinical trial was supported by AbbVie. Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Morita A, Takahashi H, Ozawa K, et al. Long-term analysis of adalimumab in Japanese patients with moderate to severe hidradenitis suppurativa: Open-label phase 3 results. Published online October 7, 2020. J Dermatol. doi:10.1111/1346-8138.15605