Adalimumab Improves Symptoms of Inflammatory Disease at First Stage of Clinical Trials - European Medical Journal

Adalimumab Improves Symptoms of Inflammatory Disease at First Stage of Clinical Trials

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THE RESULTS of two Phase III clinical trials have shown that the tumour necrosis factor (TNF)-inhibitor adalimumab can improve the symptoms of hidradenitis suppurativa (HS).

The findings of the PIONEER I and PIONEER II trials showed that HS patients receiving weekly doses of adalimumab had significantly higher response rates of symptom reduction when compared to a placebo group at Week 12.

HS is a long-term skin disease that causes abscesses and scarring on the skin, usually around the armpits, breasts, buttocks, and groin. Speaking about the disease and the results of the recent clinical trials, Prof Alexandra Kimball, Harvard Medical School, Boston, Massachusetts, USA, explained: “Both physical functioning and quality of life are severely affected, and while many treatments are used to relieve symptoms and try to get the disease under control, this largest set of placebo-controlled information to date clearly shows that improvement can result for patients.”

More than 300 patients with moderate-to-severe HS were enrolled in each of the trials and randomised into two groups. For the first stage of each trial, which lasted 12 weeks, the control group received weekly 40 mg adalimumab doses, whilst the second group received a placebo. The primary end-point was a clinical response, defined as a minimum 50% reduction from baseline in the abscess and inflammatory-nodule count, with no increase in abscess or draining-fistula counts, at Week 12. The clinical response rates at Week 12 were significantly higher for the control group (PIONEER I: 41.8%, PIONEER II: 58.9%) when compared with the placebo group (PIONEER I: 26.0%, PIONEER II: 27.6%).

At the second stage, which lasted until Week 24, patients were reassigned to receive, or to continue to receive, adalimumab weekly or every other weekly dose, or a placebo. The results showed no significant difference between patients continuing to receive a weekly dose, patients switched to a dose every other week, and those shifted to placebo. However, Prof Kimball noted that symptom severity of HS varies, and the protocol of the study resulted in treatment discontinuation for patients whose symptoms stopped responding to the drug. Therefore, larger scale studies are needed to determine the ideal length and frequency of treatment.

Nevertheless, the results do provide significant cause for optimism amongst hidradenitis suppurativa patients.


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