Guselkumab Approved for Psoriatic Arthritis

July 14, 2020
Rheumatology Network Editorial Staff

The U.S. Food and Drug Administration has approved the first IL-23 inhibitor for moderate to severe psoriatic arthritis. The newly approved treatment, guselkumab, has been shown to improve the signs and symptoms of fatigue associated with PsA.

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The U.S. Food and Drug Administration has approved the IL-23 inhibitor guselkumab (Tremfya, Janssen Biotech) for patients with moderate to severe psoriatic arthritis (PsA) who are candidates for systemic therapy or phototherapy.

It is the first IL-23 inhibitor for psoriatic arthritis and like other approved biologic therapies, it has been shown to improve fatigue in patients.

“Tremfya represents a significant milestone in the treatment of moderate to severe plaque psoriasis as evidenced by the proven skin clearance demonstrated in the majority of study patients receiving this IL-23–specific therapy at week 16 and up to week 48,” said study investigator Andrew Blauvelt, M.D., M.B.A., in a statement issued by Janssen Biotech. “We continue to make progress in understanding the science of psoriasis and the important role IL-23 plays in the pathogenesis of this disease.”

There are a number of other biologics approved for psoriatic arthritis, which include tumor necrosis factor inhibitor (TNFi) biologics etanercept, infliximab, adalimumab, golimumab, certolizumab pegol; the IL-12/23 inhibitor ustekinumab; the IL-17 inhibitor secukinumab, ixekizumab and brodalumab; the JAK inhibitor tofacitinib; and abatacept which targets CTLA4-Ig.

Existing treatments have been shown to effectively treat the signs and symptoms of fatigue which, if left untreated, can heighten disease activity, inflammation, and chronic pain leading to sleep disorders, a diminished quality of life and the increased occurrence of anxiety and depression.

“The intensity of fatigue varies significantly among chronically sick patients; however, many persons regard this symptom as one of the most troublesome,” according to Magdalena Krajewska-Wlodarczyk, the author of a 2017 review published in Reumatologia called, “Fatigue – an underestimated symptom in psoriatic arthritis.”

Guselkumab, which was previously approved to treat moderate to severe plaque psoriasis, underwent two phase three clinical trials, DISCOVER-1 and DISCOVER-2. The results, which were published in The Lancet, showed that a significant percentage of patients treated with guselkumab achieved the primary endpoint of ACR20 at 24 weeks with 52 and 64 percent of patients achieving an ACR20 response compared to 22 and 33 percent in patients treated with placebo in DISCOVER-1 and DISCOVER-2, respectively.

In addition to improving fatigue, the treatment was effective in improving psoriasis manifestations, physical function and in enthesitis and dactylitis.

Guselkumab is administered as a 100 mg subcutaneous injection every eight weeks, following two starter doses at baseline and week four. It can be used as monotherapy or in combination with a conventional Disease Modifying Anti-Rheumatic Drug (DMARD).