Patients experience painful cysts, abscesses and draining fistula, particularly under the arms and in the groin. Treatment options are limited and although it may only affect up to 1% of the population, it can take up to a decade for a patient to be diagnosed.
A potential treatment is being developed by AbbVie. Lutikizumab is a dual variable domain interleukin 1α/1β antagonist; both subtypes have been shown to be elevated in HS lesions.1
The results of a Phase II trial have been reported recently via press release. In the study, 153 adults with moderate to severe HS who had previously failed treatment with anti-TNF agents were given 300 mg subcutaneous doses of lutikizumab either every other week or every week, 100 mg doses every other week or a placebo.
For the primary endpoint of achieving the “HS clinical response 50” at week 16, both groups treated with 300 mg doses had a higher response rate (59.5% and 48.7%, respectively) compared with the placebo (35.0%).
Higher response rates were also achieved with treatment for a “skin pain” secondary endpoint at both 300 mg regimens. The 100 mg dose did not show improved efficacy compared with the placebo.
It was generally well tolerated at all doses, with the incidence of treatment-emergent adverse events being broadly similar for the combined lutikizumab treatment arms (70.8%) and the placebo (75%).
The most common adverse events were HS, diarrhoea, headache, pruritus, contact dermatitis, eczema and nasopharyngitis.
Phase III trials are now being planned. The drug has also been evaluated in other autoimmune conditions, but with less success.
For example, in a Phase II trial in knee osteoarthritis patients with synovitis, 350 patients were randomised to receive 25, 100 or 200 mg subcutaneous doses of lutikizumab or a placebo every 2 weeks for 50 weeks.
Primary endpoints were the WOMAC pain score at week 16 and change from baseline in synovitis — as assessed by MRI — at week 26.2
There was a significant improvement compared with the placebo in those given 100 mg doses, but not with the higher or lower doses. After week 16, the pain score was lower in all groups, but without a significant difference from the placebo.
Similarly, there was no significant difference in synovitis from baseline. In another trial, 132 patients with erosive hand osteoarthritis were given 200 mg subcutaneous doses or a placebo every 2 weeks for 24 weeks.3
There were no differences in pain scores or other imaging and clinical endpoints between the groups at week 16, despite assessments indicating that IL1 blockade was occurring.
References
- S.E. Lacy, et al., MAbs 7, 605 (2015).
- R.M. Fleischmann, et al., Arthritis Rheumatol. 71, 1056 (2019).
- M. Kloppenburg, et al., Ann. Rheum. Dis. 78, 413 (2019).