PBS listing for guselkumab extended to active psoriatic arthritis


By Mardi Chapman

6 Jul 2021

The PBS listing for guselkumab (Tremfya) has been extended to include adults with active psoriatic arthritis

The selective IL-23 inhibitor targeting the p19 subunit has previously only been reimbursed for moderate to severe plaque psoriasis.

The listing for psoriatic arthritis is based on results from the DISCOVER trials, as previously reported in the limbic. DISCOVER 2 involved only biologic naive patients while DISCOVER 1 included about 30% of patients who had received one or two TNF inhibitors.

More recently the COSMOS study, presented at EULAR 2021, focussed on PsA patients with an inadequate response to TNF inhibitors.

The phase 3 RCT found a significantly higher ACR20 response rate with guselkumab versus placebo at week 24 with increasing response rates at one year.

Guselumak was also superior to placebo for all major secondary endpoints including physical function, physical aspects of health-related quality of life, and PASI 100.

Queensland rheumatologist Professor Peter Nash told the limbic the IL-23 inhibitor was very good on skin, joints, enthesitis and dactylitis.

“And what’s good about the new inhibitors [Il-17s and IL-23s] is their safety. You can’t really talk safety from clinical trials because only well people go into the trials and we are waiting for registries to confirm it, but we are not seeing serious infections, we’re not seeing opportunistic infections, we’re not seeing any TB signal which is very important in the Asia Pacific region.”

“It’s an injection every couple of months after the loading dose so it is very convenient.”

“So if safety can be confirmed then the algorithm might think about changing to the IL-17s and IL-23 s before TNF inhibitors unless there is a very specific TNF reason like uveitis.”

He said the newer drugs have rewritten the expected improvement in skin scores.

“For example, with the TNFs we were happy with a PASI 75 in 60% of people. With the new therapies, the 23s and 17s, we’re getting PASI 100 – complete clearance in up to half the patients.”

“And the other thing about the medication is that people seem to improve the longer they are on it. There doesn’t seem to be a drop off in effect over time which is what is seen in some other medications.”

Professor Nash said guselkumab, like other medications, appeared to work better before a TNF inhibitor than after.

Unlike the IL-17s, there did not appear to be any association between the IL-23 and inflammatory bowel disease.

He added that head to head studies such as against IL-17 and JAK inhibitors were required.

Disclosures: The DISCOVER and COSMOS were supported by Janssen. Professor Nash is a consultant for and on the speakers bureau of a number of pharmaceutical companies including Janssen.

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