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J&J Pill Helps 58% of Arthritis Patients in Major TrialHealth
In a 552-patient late-stage trial, the oral drug icotrokinra eased joint pain and swelling far better than a dummy pill — and also cleared the skin for many patients.
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A once-daily pill helped nearly six in ten patients with psoriatic arthritis reach a key improvement mark in a late-stage clinical trial, raising hopes of a needle-free option for a disease that affects both the joints and the skin. The results were announced by Johnson & Johnson on Saturday and presented at the American College of Rheumatology meeting.
The drug, icotrokinra, is sold under the brand name Icotyde and is already approved in the United States for moderate-to-severe plaque psoriasis. It is not yet approved for psoriatic arthritis; the new findings are the first late-stage evidence the same pill could help people whose disease has spread from skin into joints.
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In the Phase 3 trial, known as ICONIC-PsA 1, 552 adults with active psoriatic arthritis who had never taken a biologic medicine were given either a 200-milligram tablet once a day or a dummy pill. After 16 weeks, 58 percent of those taking icotrokinra had achieved at least a 20 percent improvement in tender and swollen joints and other disease measures, compared with 41 percent on placebo.
Benefits went beyond the joints
The benefits were not limited to the main measure. Nearly three in ten patients on the drug reached a 50 percent improvement, against 16 percent on placebo, while 13 percent reached a 70 percent improvement compared with five percent on placebo.
The pill also helped the skin. Among patients whose psoriasis covered enough skin to be measured, 57 percent of those on icotrokinra achieved clear or almost clear skin, compared with 14 percent on placebo. More than a third, 37 percent, saw their skin symptoms improve by 90 percent, against only six percent on placebo.
Improvements continued to build over time. By week 24, 69 percent of patients on the drug had reached the 20 percent improvement mark, and 64 percent had clear or almost clear skin. Safety findings through 24 weeks were in line with what is already known about the drug, with no new safety concerns identified.
What the drug does differently
Psoriatic arthritis is a long-term condition in which the immune system attacks the joints and the skin. It causes pain, stiffness and swelling, and it commonly appears between the ages of 30 and 50. Nearly three in ten people with plaque psoriasis also develop the joint disease.
Icotrokinra works differently from the injections and infusions that many patients currently rely on. It is a targeted oral peptide that precisely blocks a receptor for interleukin-23, a signal that drives the inflammation behind psoriatic disease. Patients take one tablet a day on waking, with water on an empty stomach, at least 30 minutes before eating.
Dr Joseph Merola, a rheumatologist and dermatologist involved in presenting the findings, said the joint responses showed the exciting potential for an oral option to open a new chapter in treating psoriatic arthritis, because patients need treatments that tackle the whole burden of the disease.
There are still steps before the pill could be offered for this use. The findings were presented at a medical meeting, and regulators would still need to approve it for psoriatic arthritis before doctors could prescribe it for that condition. A second trial, ICONIC-PsA 2, is testing the drug in patients who have previously taken biologic medicines, and its results have not yet been reported.
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