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Phase II LOTUS results presented at a European dermatology meeting found that about 43% of patients receiving either abdakibart dose reached HiSCR75 at week 16, compared with about 25% on placebo. The investigational IL-1 beta inhibitor also separated from placebo on several measures as early as week 4, according to the study presenter; longer-term efficacy and safety remain unknown.
Abdakibart, an investigational interleukin-1 beta inhibitor, produced a higher week-16 response rate than placebo in a Phase II trial involving people with hidradenitis suppurativa, according to findings presented at the European Academy of Dermatology and Venereology meeting in Vienna. About 43% of patients in each of two dose groups reached the trial’s HiSCR75 measure, compared with about 25% of those given placebo, offering an early efficacy signal ahead of planned Phase III testing.
The results came from the Phase II LOTUS study, which included more than 240 participants, with about 80 assigned to each of three groups: two abdakibart dose groups and a placebo group. The primary results reported were measured at week 16. HiSCR75, or Hidradenitis Suppurativa Clinical Response 75, is a higher-depth response measure used in the trial; the supplied report does not provide further detail about its calculation.
Martina J. Porter, MD, of Beth Israel Deaconess Medical Center, presented the findings and discussed them in a MedPage Today video published November 4, 2026. Porter said the drug groups separated from placebo on several study endpoints as early as week 4. The report does not give numerical week-four results, confidence intervals, or a statistical significance assessment for the comparisons, so the size and reliability of that early separation cannot be determined from the information provided.
Porter described the 16-week safety findings as reassuring, reporting no apparent increase in infection risk and saying injection-site reactions occurred to a similar degree across placebo and abdakibart groups. Headaches were among the most common side effects observed. The account does not supply event counts, a full adverse-event table, or detailed information about treatment discontinuations, so it cannot establish the drug’s safety profile beyond the presenter’s summary of this trial period.
A New Target for HS Treatment
The results add an investigational approach to research for hidradenitis suppurativa (HS), a chronic inflammatory skin disease. The key reported difference—about 43% versus 25% reaching HiSCR75 at week 16—makes abdakibart a candidate for further testing, but it is not proof that the medicine will benefit patients in routine care or outperform available treatments. The comparison is from one Phase II study, and the supplied account does not include statistical details needed to judge how precisely the difference was estimated.
The early separation from placebo and the presenter’s summary of the short-term safety findings are relevant questions for later-stage research. If Phase III studies reproduce the response and provide longer follow-up, they could clarify whether IL-1 beta inhibition has a durable role in HS care. For now, patients and clinicians should treat the findings as early clinical evidence, not as a treatment recommendation or confirmation of long-term benefit.
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What the LOTUS Trial Measured
LOTUS tested abdakibart, which the report identifies as an IL-1 beta inhibitor, in a Phase II study with two active-dose groups and a placebo group. The results discussed were the week-16 primary endpoint findings, presented at the European Academy of Dermatology and Venereology meeting in Vienna. Avalo Therapeutics was identified as the company behind the study.
Porter said the study had more than 240 participants and characterized its size as large for a Phase II HS trial. She also noted that HS trials commonly assess response at week 16, while longer follow-up matters because disease severity may continue to change over six months, a year, or more. The source report provides no detailed trial protocol, participant characteristics, full endpoint results, or comparison with other medicines, so broader conclusions about how abdakibart compares with existing care are not supported by these figures alone.
Long-Term Results Still Pending
The findings are an early Phase II result, and the reported percentages do not by themselves show whether abdakibart will produce a statistically reliable or clinically meaningful advantage. The supplied report does not include confidence intervals, p-values, full endpoint data, or detailed participant information. It also does not state how many participants completed treatment or provide a comprehensive breakdown of adverse events.
Follow-up beyond 16 weeks is not reported here. It remains unclear whether the response will persist or improve over time, how the two doses compare with each other, and whether longer use could reveal safety issues not apparent in this trial period. The presenter’s comments about infection risk and other side effects should be understood as a summary of the available 16-week findings, not as evidence that risks are absent.
Phase III Testing and Follow-Up
Porter said abdakibart is expected to move into Phase III, where larger and longer studies can test whether the week-16 result holds up. The supplied report does not give a trial start date, planned enrollment, dosing schedule, or expected results date. Those details, along with the full Phase II data, will be needed to assess the strength of the evidence.
Further follow-up should address whether patients maintain or gain response at six months and one year, as well as the treatment’s safety over a longer period. Until those results are available and regulators review the evidence, abdakibart remains investigational; the Phase II findings do not establish that it is approved or available as an HS treatment.
Key Questions
What did the Phase II LOTUS study find?
At week 16, about 43% of patients in each abdakibart dose group reached HiSCR75, compared with about 25% in the placebo group, according to results presented by Martina J. Porter, MD.
What is abdakibart?
Abdakibart is an investigational IL-1 beta inhibitor being studied for hidradenitis suppurativa. The report describes it as a drug developed by Avalo Therapeutics.
Does the study show that abdakibart is approved for HS?
No. The report describes Phase II trial findings and says the drug is expected to move into Phase III. It does not report regulatory approval or availability as a treatment.
How certain are the efficacy and safety findings?
The results are an early signal from a study with more than 240 participants and 16 weeks of reported follow-up. The supplied account does not include statistical measures, full adverse-event counts, or long-term data, so the durability of benefit and longer-term safety remain unclear.
Source: medpagetoday.com
