Deucravacitinib can now be initiated by rheumatologists as well as dermatologists.
Rheumatologists and general physicians can now prescribe subsidised deucravacitinib (Sotyktu) and apremilast (Otezla) for adults with plaque psoriasis, after the PBS in June widened the prescriber group from dermatologists only.
The PBS streamlined authority listing criteria for both oral agents say the patient must be unable to take methotrexate or have failed to respond to six weeks’ methotrexate treatment, can only be on one of the two agents, and cannot also be on PBS-subsidised ciclosporin or biologics.
Patients who don’t respond to apremilast and deucravacitinib must have a Psoriasis Area and Severity Index (PASI) assessment before transitioning to biologics.
Deucravacitinib, the TYK2 inhibitor beat placebo and apremilast in the year-long phase III POETYK PSO-1 RCT in adults with moderate to severe plaque psoriasis, with 58% of subjects on deucravacitinib achieving a 75% reduction in PASI score vs 35% on apremilast.
Dr Anna Antony, a consultant rheumatologist at Monash Health, said the expansion was welcome, given only around 60% of patients were able to achieve minimal disease activity.
“The psoriasis efficacy data clearly favours deucravacitinib over apremilast,” Dr Antony told Rheumatology Republic.
“There were similar risks of nasopharyngitis in both arms, but the risk of URTIs was higher in the deucravacitinib group while the risks of headache, nausea, and diarrhoea were higher in the apremilast group. The EAIR/100PY for Zoster infections was 1.2 in the deucravacitinib arm at 52 weeks, but there were fewer adverse event-related discontinuations in the deucravacitinib arm.”
In patients with psoriatic arthritis, the POETYK PSO-1 trial also found that 30% of those on deucravacitinib had a 50% improvement in joint pain after 24 weeks, compared with 16% of patients on apremilast.
“The main benefit of this broadening of streamlined prescribing is that rheumatologists are able to prescribe these agents in patients with moderate-to-severe skin PsO, in order to optimise their skin and joint disease activity,” Dr Antony said.
“This is particularly beneficial for patients who do not meet PBS criteria for a bDMARD/other tsDMARD on the PsO or PsA pathways or have difficulties accessing a dermatologist.
“If the patient is being worked up towards accessing a biologic on the psoriasis pathway in the future, it is important to document an assessment of PASI after six weeks of treatment commencement or within four weeks of cessation as this information is necessary for psoriasis PBS biologic applications. The use of these agents do not contribute to PsA PBS biologic applications, which is an important consideration.
“Pre-screening for latent infections remains important, as is the monitoring for ongoing infections, increased triglycerides, abnormal liver function tests and asymptomatic CPK elevation. Long-term data is needed for other adverse events potentially associated with JAK-pathway inhibition in PsA patients.”
Both deucravacitinib and apremilast can be continued by GPs in agreement with a treating rheumatologist or dermatologist. Dr Antony said this was particularly useful for patients who had trouble seeing a non-GP specialist, but stressed the importance of communicating the risks.
Last year when deucravicitinib was first PBS-listed, Associate Professor Peter Foley, a dermatologist at St Vincent’s Hospital, Melbourne, said the listing was a “major milestone in helping to address the substantial, unmet, clinical need for these patients”.
“With Sotyktu, we’ve got an agent that approaches the efficacy of some of the biologics without knocking the biologics out of the ranking as the most effective agents we have,” he said.
“It is the best oral agent we have available in 2023 in terms of its response rate and its safety profile.”
