NEW YORK (Reuters Health) – The anti-inflammatory drug adalimumab can provide significant relief for about a quarter of people who suffer from a moderate-to-severe case of the chronic skin condition hidradenitis suppurativa, according to two 36-week trials.
But the drug – which would cost over $104,000 per year for the weekly injections used in the study, according to data from Drugs.com – usually did not cure patients and its effectiveness seemed to fade a bit after the initial 12 weeks of therapy. Still, researchers say it’s a promising advance against a devastating skin condition that has no cure.
The new findings appear in the Aug. 4 New England Journal of Medicine.
Hidradenitis suppurativa, also known as acne inversa, often affects body areas where the skin folds, such as the armpits, the groin and under the breasts, producing clusters of abscesses and areas that look as if they’re infected. It’s found in 1% of the population and is more common in women.
“It’s often disabling. The lesions can be extremely painful and emotionally this is traumatizing,” said Dr. Jeffrey Sobell, an assistant professor of dermatology at Tufts University School of Medicine in Boston, who was not connected with the research. “For such a devastating disease, this is really a big victory for patients.”
Because many doctors are unaware of it, it takes an average of seven years for the condition to be diagnosed. “Patients go from emergency room to emergency room to be treated for boils,” Dr. Sobell told Reuters Health by phone.
In one test, involving 307 volunteers, 41.8% of the patients getting 40 mg of the drug weekly showed a reduction of at least 50% in the number of abscesses and inflammatory nodules. The reduction rate among placebo recipients was 26.0% (p=0.003).
The second test, reported in the same paper, produced comparable results in a group of 326 patients; the drug elicited a 58.9% response rate versus 27.6% for placebo group (p<0.001).
“The magnitude of improvement with adalimumab treatment in our patients was relatively modest as compared with adalimumab treatment in patients with other diseases, and our patients were unlikely to have complete resolution of their symptoms,” writes the team, led by Dr. Alexa Kimball of Harvard Medical School in Boston.
But Dr. Kimball told Reuters Health in a telephone interview that continued treatment may improve the success rate.
“It is a disease that really takes a long time to get a handle on,” said Dr. Kimball. “It’s exciting to have this as a treatment option for patients and it can help them get some relief. We have a long way to go but this is a huge step forward.”
AbbVie, which sells the drug under the brand name Humira, paid for and was directly involved in the studies, known as PIONEER I and II. The drug is also used to treat rheumatoid arthritis, Crohn’s disease, and psoriasis.
No serious side effects were seen.
The tests were conducted at 101 sites in 14 countries. In PIONEER I, volunteers receiving oral antibiotic therapy had to stop treatment at least 28 days before baseline; in PIONEER II they did not.
“I can’t emphasize how important this is for this community that has had very little data-driven research and no previously approved drug,” said Dr. Kimball. “There’s a huge level of suffering – there’s pain, odor, disfigurement and lack of knowledge. This is the beginning, I think, of a real era of progress.”
Several of Dr. Kimball’s co-authors reported financial ties to AbbVie, including employment.
SOURCE: http://bit.ly/2aCUHoM; N Engl J Med 2016.