August 30, 2021, Montréal, Canada – Vantage BioTrials, a full service Contract Research Organization (CRO), is proud to have successfully managed, and completed approximately 12 months in advance, a Phase IV observational, multicentre, postmarketing study in adult patients with a clinical diagnosis of moderate-to-severe Hidradenitis suppurativa (HS).

The primary objective of this clinical trial was to measure real-world effectiveness of adalimumab in HS and to secondarily observe clinical </span>course of HS in the light of patients’ response.

In SOLACE, adults with moderate-to-severe HS in need for change in ongoing therapy were treated with adalimumab for up to 52 weeks as per physician s medical practice. Treatment effectiveness was measured by ’Hidradenitis Suppurativa Clinical Response (HiSCR). Inflammatory nodules, abscesses and draining fistulas were counted, Hurley stage was assessed, and disease severity was rated using the International HS Severity Scoring System&nbsp; (IHS4). A post hoc analysis further explored the HiSCR response by abscess and inflammatory nodule (AN) count at&nbsp; baseline (low, medium and high) and gender. Spontaneously reported safety events were collected.

From 23 Canadian centres, 69% of the 138 patients achieved HiSCR at week 24, which increased to 82% and 75% at week 52 in patients with medium and high AN counts, respectively. Gender (4 times the odds for female) and age&nbsp; at HS onset (5% decrease with each additional year) had an effect on achieving HiSCR. Treatment with adalimumab led to an important decrease in number of lesions in responders, with most gains observed in inflammatory nodules, more frequently in the lower body area of patients in the high AN count group. The IHS4 scores of responders were substantially lowered, with a larger decrease in patients of the high AN count group. No new safety signal was detected.

Conclusions

The effectiveness of adalimumab was maintained during this 1-year period, and an optimal gain was documented
for patients with medium and high AN counts. These real-world data support a prompt treatment of HS patients
and the use of IHS4 to monitor treatment.

About Vantage BioTrials

Vantage BioTrials is a Contract Research Organization that uses innovative clinical trial management strategies for the life science industry with a focus on patient safety &amp; advancing new therapies to market. We offer pharmaceutical, biotech &amp; medical device companies a complete and integrated set of full service clinical trial management solutions at a competitive value.