A recent trial has revealed that ixekizumab, when used off-label, shows potential in restoring clinical response for hidradenitis suppurativa (HS) patients who have developed secondary resistance to adalimumab.
HS is a chronic inflammatory skin condition with approved treatments including adalimumab, secukinumab, and bimekizumab. Adalimumab, a tumor necrosis factor-alpha inhibitor, is typically administered via subcutaneous injection at a dose of 40 mg weekly or 80 mg every other week. Ixekizumab, an interleukin-17A inhibitor, has only been evaluated in a few HS cases for off-label use.
This study was a retrospective case series involving 10 HS patients in Germany, mostly females with a mean age of 39.7 years and a median age at diagnosis of 34 years. All patients had experienced secondary resistance to adalimumab, defined as the recurrence of at least one fistula or a worsening of the disease response by at least 75% after 16 weeks of treatment.
In 2019, when adalimumab was the only approved biologic for HS, these patients began receiving off-label ixekizumab treatment. The dosing regimen was 80 mg every two weeks for the first three months, followed by every four weeks. Clinical outcomes were measured using the International Hidradenitis Suppurativa Severity Score System (IHS4), with scores above 11 indicating severe disease. The Dermatology Life Quality Index (DLQI), a 10-item scale, was used to assess quality of life, with measurements taken at baseline and after 16 weeks of treatment.
Results showed that the average IHS4 score decreased from 13.6 at baseline to 9.6 after 16 weeks. Seven patients experienced a significant reduction in inflammatory lesions during treatment, although three developed new lesions during the trial period. At 16 weeks, five patients achieved an IHS4-55 response, meaning their IHS4 score decreased by 55% compared to baseline. However, three patients showed no response, and one patient’s condition worsened despite initial improvement at week four. The average DLQI score dropped nearly four points from 11.7 to 7.8, with two patients experiencing a reduction of over ten points.
Despite limited prior research, existing case studies support these findings. Studies by Wu et al. and Iannone et al. reported reduced lesion swelling with few recurrences and no adverse events, showing a “trend toward efficacy and safety” as the authors noted.
However, the trial had limitations, including its retrospective design, short duration, and small, homogeneous sample size. Additionally, IHS4 score assessments may be subjective. Future research should include larger, open-label, placebo-controlled studies to evaluate the long-term efficacy and safety of ixekizumab in HS patients, particularly those who have failed adalimumab.
“From experience with psoriasis and other chronic inflammatory diseases, there is a need for a variety of targeted treatments, especially considering the potential for secondary loss of efficacy or primary non-response,” the authors concluded.
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