WROCLAW, Poland — When methotrexate is added to adalimumab (Humira, AbbVie) or infliximab (Remicade, Janssen), patients with severe hidradenitis suppurativa are less likely to develop antibody resistance and more likely to see symptom improvement, new research shows.
"I think we can change dermatology by prescribing an anti-TNF with methotrexate at the beginning of treatment" for the hardest-hit hidradenitis suppurativa patients, said Pierre-Andre Becherel, MD, from Antony Hospital in France.
"This could be an important change in practice," he told Medscape Medical News. "Methotrexate is readily available and is a very well-tolerated molecule," so the approach "seems promising."
Adalimumab is the only biologic approved by both the US Food and Drug Administration and European Medicines Agency for hidradenitis suppurativa, but off-label infliximab is commonly used for the chronic inflammatory skin condition.
However, a large number of patients become resistant after developing antibodies to the drugs, reducing serum levels over time, Becherel explained.
He presented preliminary findings from the first 32 of 240 study patients here at the Conference of the European Hidradenitis Suppurativa Foundation 2019.
Early Finding, More Work to be Done
Participants received adalimumab or infliximab alone or in combination with methotrexate 20 mg per week. All patients were categorized as stage 2 or 3 on the Hurley disease-severity scale, and average age in the preliminary cohort was 34 years.
Clinical evaluations were conducted at 3 and 6 months. Clinical response — a reduction in abscesses and inflammatory nodules of at least 50% — was measured with the Hidradenitis Suppurativa Clinical Response (HiSCR) score. Anti-drug antibodies to adalimumab or infliximab were tracked and linked to clinical response in each patient.
More patients taking the biologic-plus-methotrexate combination than biologic monotherapy achieved a clinical response at 6 months (75% vs 50%).
At month 3 and month 6, the better clinical response in the combination groups correlated with higher serum levels of the biologic — adalimumab or infliximab — and lower levels of anti-drug antibodies.
These findings were received with enthusiasm by the more than 200 members of the audience.
"I think it's a good approach to an important question, because a lot of good studies show a loss of efficacy in adalimumab and infliximab over time," said Wayne Gulliver, MD, from Memorial University of Newfoundland in St. John's, Canada.
"This is a good strategy," he told Medscape Medical News. Of the more than 500 patients with hidradenitis suppurativa he has treated over the past 15 years, about 60% have experienced drug resistance to biologic therapies, he added.
Becherel reports financial relationships with AbbVie, Novartis, and Janssen. Gulliver reports financial relationships with AbbVie, Amgen, Eli Lilly, Novartis, Pfizer, Actelion, Amgen, Arylide, Boehringer, Celgene, Cipher, Galderma, Janssen, Tribute, Astellas, LEO Pharma, and Regeneron.
Conference of the European Hidradenitis Suppurativa Foundation (EHSF) 2019: Abstract 022 OS04-05. Presented February 7, 2019.
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Cite this: Methotrexate Added to Biologic Eases Inflamed Skin - Medscape - Feb 08, 2019.