Vantage BioTrials Successfully Manages Real-World Effectiveness of Adalimumab in Patients with Moderate-to-Severe Hidradenitis Suppurativa: the 1-Year SOLACE Study
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 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 (IHS4). A post hoc analysis further explored the HiSCR response by abscess and inflammatory nodule (AN) count at 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 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.
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.
For more information about this article or to download the full PDF version, click here or read about it in JEADV (The Journal of the European Academy of Dermatology and Venereology) by visiting the Wiley Online Library.
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