The THESEUS study was conducted to look at current HS management and the influences on treatment decisions, with the goal of informing future randomized controlled trials.
Deroofing and laser treatments were established by the Hidradenitis Suppurativa Evaluation Study for patients in the United Kingdom with hidradenitis suppurativa (HS), according to recent findings, and the study developed a network of 10 centers for future randomized control trials (RCTs).1
This research was titled the Treatment of Hidradenitis Suppurativa Evaluation Study (THESEUS), and it looked into oral treatments for HS, the effects of HS, the effects of different treatments on those with HS, and and what the most effective surgical procedures are to perform for HS patients.
One such procedure is known as deroofing, involving the precise removal of subcutaneous skin tunnels in HS by utilizing blunt skin probing, followed later by the removal of the tunnel’s roof and subsequent healing of the base.2 This process exists in various countries, though it is not performed in the UK.
The investigators of THESUS, led by John R. Ingram from the Division of Infection and Immunity at Cardiff University in the UK, also acknowledged that laser treatment of HS directed at patients’ hair follicles is also currently not employed by UK clinicians.
“The Treatment of Hidradenitis Suppurativa Evaluation Study was designed as a prospective cohort study to introduce deroofing and laser treatment for HS in the UK and to understand how conventional surgery and oral antibiotics are currently used,” Ingram and colleagues wrote.
The research team of the THESEUS study sought to better comprehend the patient pathways for those with HS, to better understand elements affecting treatment choices for patients and for physicians, and to implement such insights to design future RCTs.
They also attempted to evaluate the feasibility of enrolling those with HS into clinical trials, to fully characterize the drug and procedural interventions in THESEUS, to assess the potential feasibility and responsiveness of Outcome Measurement Instruments (OMIs) in trials related to HS, and to examine consensus-agreed recommendations for upcoming RCT studies.
The investigators utilized a design which was multicenter, prospective, and observational over 10 hospital centers found in the UK, with their design involving 5 potential options for treatment, nested process assessment with subject and physician discussions, and the use of an end-of-study consensus workshop.
The investigators drew their subjects from various types of hospital settings, with these participants being aged 18 or older and having active HS shown not to be adequately controlled by existing therapies. They allowed intervention switching by the subjects following an initial 6-month timeframe, with additional follow-up and reviews every 3 months.
The study interventions encompassed various approaches, such as oral medications, deroofing ,laser treatment, and conventional forms of surgery, with subjects’ choices being guided by physician counsel in part.
The main outcomes assessed by the investigators looked at the percentage of subjects considered eligible and hypothetically willing to take part in the interventions. The secondary outcomes assessed by the team included reasons for treatment choice and switches, participant choices, fidelity to treatment, loss to follow-up, and effectiveness estimates following half of a year.
In the period between February 2020 - July 2021, the research team involved 151 subjects were in the research, finding that follow-up rates were shown to be 89% and 83% at 3 and then 6 months. These rates dipped to being 70% and then 44% at 9 and 12 months as a result of pandemic-related delays.
The team explained that the population had an average age of about 36 years, with 81% being identified as female, 20% as Asian, Black, or Caribbean, 64% as current or former smokers, and 86% having an elevated body mass index (BMI). At baseline, the investigators noted that 69% reported moderate disease severity, 19% reported severe, and 13% reported mild.
Overall, the research team reported that laser treatments ended up having highest eligibility among participants as well as the highest hypothetical willingness at 69%. This was then followed by use of deroofing at 58%, use of conventional methods of surgery at 54%, oral clindamycin and rifampicin combination at 44%, and doxycycline at 37%.
As far as first choices for HS treatment, 41% of subjects put laser treatments. The effects of physician guidance were shown by the team to have substantially impacted willingness for such treatment, seen in both the cohort and qualitative trials.
Doxycycline fidelity was found by the team to be only 52% following 3 months as a result of ineffectiveness, general preferences, and adverse effects. The team also found procedural intervention delays were common, as only about 43% and 26% of the subjects began laser therapy or deroofing, respectively, following 3 months.
Switching, the investigators noted, was rare, and they saw no serious adverse events in the course of their work. There were daily pain score text messages initiated for 110 of the subjects, with decreasing responses observed by the team over time and the highest number being during the first 14 days.
The investigators reported that their consensus workshop ended up looking at laser treatment and deroofing as possible future interventions in RCTs.
“The nested qualitative study provided multiple insights for future trials,” they wrote. “A RCT with an active comparator will need to ensure equipoise for participants and clinicians and provide equivalent information, for example study videos, for each intervention. Flexibility should be offered where possible for in-person or remote appointments.”