It’s been a big year in rheumatology, with covid vaccines, JAK inhibitor safety and drug news dominating headlines.
2021 told through our most-read stories.
It’s been a big year in rheumatology, with covid vaccines and JAK inhibitor safety dominating headlines – and also our most-read stories.
The PBAC recommendation to give rituximab an unrestricted listing and the availability of the Shingrix recombinant subunit adjuvanted zoster vaccine also aroused a fair bit of interest, as did the looming end to image-based prescribing – though it has just been announced that the cease date has been extended to 31 March 2022. And it was great to see the important PMR research by Dr Jessica Leung and Dr Georgia Harris gain a lot of traction in our community.
The most-read story of the year by a long way was when Gilead withdrew its TGA application for filgotinib (Jyseleca) for use in Australia back in March.
The decision took Australian rheumatologists by surprise: filgotinib was recommended for scheduling in December 2020 and was due to be raised at the March 2021 PBAC meeting for inclusion in the PBS, where it was expected to get the green light. However, it followed Gilead’s December 2020 decision in the US to withdraw its application to the FDA.
This led to one of the year’s top feature articles, What now for JAK inhibitors?.
It focused mainly on the filgotinib story and the concerns about its risk-benefit profile, especially for male fertility, although there were also commercial elements to Gilead’s decision.
The article also touched on the tofacitinib safety studies, which at that stage indicated there were higher rates of adverse cardiovascular events and malignancies but had not yet led to FDA safety warnings.
The safety warnings came in due course and were extended to baricitinib and upadacitinib.
In a black box blow for all JAK inhibitors, the FDA issued a drug safety communication in September requiring warnings about increased risk of serious heart-related events, cancer, blood clots and death for JAK inhibitors that treat arthritis and ulcerative colitis.
In the wake of the boxed warnings, RR deputy editor Dr David Liew invited Associate Professor Helen Keen and Associate Professor Andrew Östör to put aside their magnanimity, don their best debating jackets, and make their case for and against the contention that JAK inhibitors have failed to meet their promise.
Of course, what everyone was waiting for was the full data from the ORAL surveillance studies.
While still not published, the data was given a fair bit of coverage at ACR 2021. Findings presented in plenary, poster and abstract sessions started to flesh out what led to the FDA boxed warnings, with the FDA also sharing some of their thinking behind the extension to baricitinib and upadacitinib.
Amid the JAK inhibitor dramas and controversies, there was plenty of news action on covid and its impacts on rheumatology patients.
The American College of Rheumatology drafted its guidelines for vaccines earlier in the year, and in February held a town hall to explain its rationale and address clinicians’ queries and concerns about methotrexate and abatacept withholding time frames, flares, antibody testing and more.
With data on covid vaccines and immunogenicity gradually filtering in from both real life and lab studies, another big covid story was on the ATAGi booster recommendations. To address the risk of suboptimal or non-response to the standard two-dose vaccination schedule, ATAGI recommended a booster for everyone over 12 with a condition or on medication leading to severe immunocompromise.
However, rheumatologists raised questions about some aspects of the advice, including which patients should get the booster, which vaccine is best and what to do with patients on JAK inhibitors or SSZ/HCQ combination therapy.
And so, on to the rest of the year’s most-read stories …
In an under-the-radar intracycle meeting in September, PBAC recommended that the PBS listings for all listed brands of rituximab be changed from authority required to unrestricted benefit listings.
The potential implications are enormous: provided the federal government accepts the recommendation and listing arrangements are finalised, this will be the first immunomodulatory biologic to be made available without restriction on the PBS, and potentially opens the door to subsidised treatment for patients with conditions that are currently not adequately catered for.
In other drug news, ATAGI issued a statement on zoster vaccines for older adults where it recommended Shingrix for the prevention of herpes zoster and associated complications in immunocompromised adults.
Shingrix became available on the Australian market in July, though it is not currently included in the National Immunisation Program (NIP).
After years of flying under the radar, polymyalgia rheumatica (PMR) is finally getting some airtime. Rheumatologist Dr Jessica Leung and intern Dr Georgia Harris researched the PMR patient experience at Melbourne’s Austin Hospital and presented the findings at APLAR 2021. They spoke to the Rheumatology Republic’s In conversation podcast about their research.
Digital image prescriptions allow a doctor to send a photo or fax of a paper script to a pharmacy and were introduced as an interim measure to support telehealth during covid – the key word here being interim. It was scheduled to end in September, leaving only electronic prescribing which was not compatible with practice management software used by most specialists.
However, there was in the end a stay of execution to 31 December, and it was announced on 22 December that it has been further extended to 31 March 2022.
With covid still stymying attempts to hobnob with the latest and greatest in rheumatology research, the 2021 ARA ASM went ahead in a hybrid format, live in Sydney and with hubs available in other cities. As well as local experts, e-guests included Professor Mikkel Østergaard (Denmark), Associate Professor Alexis Ogdie-Beatty (USA), Professor Dan Solomon (USA), Professor Peter Merkel (USA) and Dr Kanta Kumar (UK).
But forget an aircraft hangar brimful of posters – they were all online. A total of 126 posters were submitted and a four-person judging committee rated each poster for scientific merit and clarity of message. We presented their top ten.
