Targeted therapy finally on the PBS for lupus


By Mardi Chapman

2 Jul 2024

Professor Eric Morand

PBS listing of anifrolumab (Saphnelo; AstraZeneca) for the management of patients with severe SLE with high disease activity despite standard of care therapy has been welcomed by clinicians and patient organisations.

It is the first targeted treatment for lupus to be listed on the PBS.

The PBAC recommended anifrolumab at its March 2024 meeting on the basis that it “provides, for some patients, a significant improvement in efficacy over SOC alone for the management of SLE in the requested population.”

It had previously rejected as recently as March 2023 on the basis that the magnitude of benefit associated with anifrolumab was uncertain and that the economic model was highly uncertain.

Professor Eric Morand, Director of Rheumatology at Monash Health, led the global TULIP-2 trial which found the addition of anifrolumab to standard therapy resulted in a higher percentage of patients with a BICLA response compared to placebo (47.8% v 31.5%; P=0.001).

The study [link to NEJM here] resulted in the approval of anifrolumab around the world – for example by the US FDA and the European Medicines Agency in 2021.

Other evidence for anifrolumab, from post-hoc analyses of pooled data from the TULIP-1 and TULIP-2 trials, has included:

  • a benefit in skin, joint, and haematological domains of lupus [link here]
  • a glucocorticoid-sparing effect [link here]
  • a reduction in flares [link here]
  • lupus low disease activity state (LLDAS) attainment [link here]

Another analysis of pooled data from the MUSE and TULIP trials also demonstrating acceptable safety of the monoclonal antibody [link here].

Professor Morand said in a statement from Monash University, that SLE was a debilitating disease with no cure and limited treatments.

“No new therapy has been available on the PBS for SLE in Australia for 60 years and the unmet need for new medicines is urgent,” he said.

“The use of new medicines like anifrolumab is now recognised by global treatment guidelines as part of the standard of care, and it is such welcome news that Australian patients now stand to benefit from this breakthrough.”

Professor Morand said the goal of treatment in lupus was to move beyond simply managing symptoms to targeting the cause of disease, resulting in attainment of proven states of better health.

“This listing provides a much-needed treatment option to a complex and chronic disease.”

Vu Nguyen, secretary and founder of Lupus Victoria, which supports people living with lupus and fundraises to advance lupus research, also said there had been no significant advancement in lupus treatments for many years.

“It’s important that treatments like anifrolumab are listed on the PBS so that they are affordable and accessible for eligible Australians living with moderate to severe SLE,” she said.

“Lupus Victoria is dedicated to making a difference in the fight against lupus and works to raise funds for vital research to build a brighter future for those affected by this chronic disease.”

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