News · Longevity & Aging
A daily pill beat placebo for hidradenitis suppurativa across two trials of 619 patients
Hidradenitis suppurativa is painful, common and badly served by existing drugs. Two phase 3 trials tested an oral treatment where almost everything available is injected.
- About 40% of treated patients halved their abscess and nodule count, against about 30% on placebo.
- Both trials found the same result, which is unusual in this condition.
- The two doses tested performed about the same as each other.
- Acne was the commonest side effect, in roughly one in five.
- Most patients on the drug did not reach the response threshold.
Hidradenitis suppurativa is more common than psoriasis and far less known. It produces painful abscesses in the armpits, groin and under the breasts, it scars, and patients typically spend years being treated for recurrent boils before anyone names it.
The treatments that work are injected antibodies. They are expensive, need refrigeration, and require a specialist to prescribe them, which in practice means many patients get antibiotics and surgery instead.
How the two hidradenitis trials were run
Writing in Nature Medicine, researchers ran two parallel phase 3 trials of an oral drug that dampens a specific immune signaling pathway, at two different doses against placebo.
Running two trials at once is the design choice worth noticing. In a condition with a large placebo response and a noisy outcome measure, a single positive trial is a weaker claim than the same result arriving twice.
How many patients halved their lesion count
In the first trial, about 40% of patients on either dose halved their count of abscesses and inflammatory lumps, against about 30% on placebo.
In the second, about 42% on either dose reached the same mark, against about 29% on placebo.
The two doses performed about the same as each other, which suggests the lower one is already at the top of the dose-response curve. That is useful information, because the higher dose of a drug like this carries more risk without apparently buying more benefit.
Why most patients on the drug did not respond
A ten-point gap over placebo is real. It is also a long way from clearing the disease.
Three in five patients on the drug did not halve their lesion count. The yardstick itself measures halving rather than resolution, so even the responders were not necessarily well. This is a condition where treatments are judged against a low bar because the bar is where the evidence is.
That is not a reason to dismiss it. It is a reason to describe it accurately: a modest, replicated benefit, delivered in tablet form, in a disease where the alternative is an injection or nothing.
What 54 weeks of povorcitinib cost in side effects
Through the first twelve weeks, serious adverse events occurred in about 1-2% of patients on the drug and 2-3% on placebo, which is to say no signal.
Over 54 weeks of continued treatment they rose to about 5-6%. The commonest ordinary side effect was acne, in roughly one in five, followed by colds and upper respiratory infections. One death was reported and judged unrelated to treatment.
Drugs in this class carry class-wide warnings that a year of follow-up in a few hundred patients cannot settle. Nothing unexpected appeared here, which is different from nothing existing.
Why a tablet reaches patients an injection does not
There are many different problems and conditions which can affect your skin, and they vary enormously in how seriously they are taken.
Hidradenitis suppurativa has been undertreated partly because effective therapy meant specialist biologics. A tablet with a modest effect that a general dermatologist can prescribe may reach more people than a better drug that most patients never get offered.
That is the argument for this result mattering more than its effect size suggests, and it depends entirely on whether regulators agree.
People also ask
What did the trials find?
In STOP-HS1, 40% on 45 mg and 41% on 75 mg achieved HiSCR50 against 30% on placebo (odds ratio 1.6 for both doses; P = .0240 and P = .0214). In STOP-HS2 the figures were 42% for both doses against 29% (odds ratios 1.8 and 1.9; P = .0035 and P = .0033). Serious adverse events occurred in 1-2% on the drug and 2-3% on placebo through week 12.
What is hidradenitis suppurativa?
A long-term inflammatory skin disease producing painful lumps and abscesses where skin rubs together, typically the armpits and groin. It scars, it recurs, and it is frequently misdiagnosed as ordinary boils for years.
What does HiSCR50 mean?
A 50% reduction in the count of abscesses and inflammatory nodules, with no increase in draining tunnels or abscesses. It is the standard yardstick in this condition and it measures halving rather than clearing.
Is a 10-point gap over placebo impressive?
It is a genuine effect and a modest one. The more sobering way to read the same numbers is that roughly three in five patients on the drug did not reach the threshold, which is normal for this disease and not a reason to celebrate.
Why does an oral option matter?
Because the effective treatments in this condition are mostly injected biologics, which require refrigeration, needles and specialist prescribing. A tablet changes who can realistically be treated and how quickly.
What were the side effects?
Acne in roughly one in five, alongside common infections such as colds and upper respiratory infections. Serious adverse events were no more frequent than on placebo at 12 weeks, rising to 5-6% over 54 weeks of continued treatment.
Should a patient ask for this?
It is not yet an approved treatment and availability will depend on regulators. Anyone with painful recurrent lumps in those areas is worth referring to a dermatologist regardless. This is general information rather than medical advice.