News in brief: Rituximab recommended for unrestricted PBS listing; COVID-19 vaccines potentially linked with increase in GCA and PMR; Foot orthoses improve pain in kids with JIA

20 Oct 2021

Rituximab recommended for unrestricted PBS listing

Rituximab may soon have an unrestricted benefit listing on the PBS following a recommendation from the Pharmaceutical Benefits Advisory Committee.

At its September meeting the PBAC recommended that following numerous requests the PBS listings for all listed brands of rituximab be changed to Unrestricted Benefit listings. In making its decision, the PBAC said it considered that changing the rituximab listings to unrestricted would provide subsidised access to treatment for patients with conditions where there are no alternative PBS listed medicines.

And following the delisting of the reference brand of rituximab IV, MabThera, the PBAC recommended removal of the administrative notes related to the biosimilar uptake drivers for biosimilar brands such as  Riximyo and Truxima. The PBAC recommendations are subject to approval by the Federal minister for health


 GCA and PMR increases linked to COVID-19 vaccine

Giant cell arteritis (GCA) and polymyalgia rheumatica (PMR) might be linked with COVID-19 vaccination but the risk seems to be lower than that with influenza vaccines, a study has concluded.

A research team from France used VigiBase, the WHO’s global individual case safety report database, to assess whether GCA or PMR were differentially reported with COVID vaccines versus influenza vaccines.

The results, published in Rheumatology, found that up to June 30 this year there were 1,295,482 reports in VigiBase related to COVID-19 vaccines, among which there were 147 cases of GCA, 290 of PMR and 9 of GCA with PMR.

Of 317,687 reports concerning influenza vaccines, there were 78 cases of GCA, 303 of PMR, and 14 of GCA with PMR.

The researchers concluded that COVID-19 vaccines were linked with an increased reporting in GCA (reporting odds ratio [ROR] of 2.7) and PMR (2.3), but not when compared with use of influenza vaccines (0.5 and 0.2, respectively).

“Overall, our study supports a potential safety signal for GCA and PMR with COVID-19 vaccines [but] further data are needed to confirm this signal,” the researchers concluded. Nevertheless, the benefits of COVID-19 vaccines “dramatically [outweigh] this potential risk, that appears very rare according to the billions doses administered so far,” they stressed.


Foot orthoses improve pain in kids with JIA

Customised, preformed foot orthoses could help reduce pain and tender joints in children with juvenile idiopathic arthritis (JIA), an Australian study has shown.

The study assessed the efficacy of personalised versus standard, flat innersoles on pain, quality of life, lower joint swelling and tenderness, and foot and ankle disability in 66 children with JIA.

It found the innersoles customised based on biomechanical assessments reduced pain in patients at four weeks and three months post intervention and midfoot and ankle joint tenderness at six months, the authors wrote in Rheumatology, though they did not improve quality of life or disability and long-term efficacy remains unclear.

The custom device was “safe, inexpensive and well-tolerated by paediatric patients”, they added.

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