With COVID-19 vaccination about to start in Australia, rheumatology patients face a key question: should they risk a flare by skipping a dose of immunomodulator to avoid a potential blunting of response to the vaccine?

This is one of the issues addressed by an expert panel convened to develop COVID-19 vaccine guidance for rheumatology clinicians, which has this month released advice that patients with  Autoimmune Inflammatory Rheumatic Disease (AIIRD) should be prioritised  for vaccination, based on their increased risk of hospitalisation and worse outcomes.

The recommendations were developed by the American College of Rheumatology (ACR) COVID-19 Vaccine Clinical Guidance Task Force, a multi-disciplinary panel of nine rheumatologists, two infectious disease specialists, and two public health experts and based on a series of expert literature reviews.

The Task Force found no evidence to support concern or timing of immunomodulatory therapies in relation to vaccine safety. And beyond known allergies to vaccine components, the ACR found no additional contraindications to COVID-19 vaccination for autoimmune and inflammatory rheumatic disease patients.

But the group did flag evidence suggesting that many patients on systemic immunomodulatory therapies would likely experience a ‘blunted’ response to the vaccine in both ‘magnitude and duration’ compared to the general population. This prompted guidance on optimising vaccine response in patients with high disease activity and those on immunosuppressants.

This includes recommendations to modify treatments such as methotrexate, JAK inhibitors and some biologics like abatacept and rituximab in the lead up to receiving the vaccine.

While the Task Force acknowledged a moderate level of evidence for a ‘theoretical risk’ of AIIRD (Autoimmune Inflammatory Rheumatic Disease) flare or disease worsening following COVID-19 vaccination, it agreed that the benefit of COVID-19 vaccination for patients ‘outweighs the potential risk for new onset autoimmunity.’

Holding therapy is controversial: ARA

Speaking to the limbic, Australian Rheumatology Association president, Professor Catherine Hill, agreed that some patients may not get as good a response to the vaccine as the general population, but says holding therapy is controversial.

“There is data that the strategy might be beneficial around flu vaccination, which may be behind the US recommendations, but the problem is if a patient flares they might need steroids and that’s associated with increased risk. So the aim of the game is to try to keep steroids to a minimum,” she cautioned – adding that the ARA is awaiting more data before making its own recommendations on COVID-19 vaccination in patients on DMARDs.

While the US guidance states that the benefit of COVID-19 vaccination outweighs risk to rheumatology patients, Professor Hill points out the very different risk-benefit ratio the Australian setting presents.

“[COVID-19] is endemic in the US whereas we have very little community transmission here, so if a patient in Australia gets a slightly more blunted response to the vaccine but avoids the risk of flare that’s probably OK because we have so little COVID around.”

But Professor Hill said the risk-benefit ratio would be different for healthcare workers with rheumatic disease.

“I know there are a lot out there and I think it’s going to depend on background risk and potential exposure risk of the individual too. I think we’re going to have to do some more personalised thinking around the risk-benefit in stopping DMARD doses before and after vaccination,” she said.

For the moment, it’s not a strategy the ARA president is advising to patients.

“My priority is that I won’t be skipping doses unless I get more data to suggest DMARDs do significantly blunt vaccine response. I might tell patients to skip a dose of methotrexate for example because the risk of flare missing one dose of methotrexate is pretty low and if it improves the vaccine response then I’d be happy with that.”

Timing of medications

In its guidance the US taskforce recommends holding methotrexate one week after vaccine dose, for those with well-controlled disease with no modification to vaccine timing.

JAK inhibitors are also recommended to be held one week after each vaccine dose while abatacept should be held both one week prior to and one week after the first COVID-19 vaccine dose with no interruption at second dose.

Meanwhile for patients taking ritiuximab, the panel recommends  scheduling vaccination so that the vaccine series is initiated about four weeks prior to the next scheduled rituximab cycle, assuming the patient’s COVID-19 risk is low or is able to be mitigated by preventive health measures like  self-isolation, the group advised. A delay of two to four weeks is also proposed after the second vaccine dose so long as disease activity allows.

The panel suggests timing the administration of IV abatacept so that the first vaccination will occur four weeks after abatacept infusion with the subsequent abatacept infusion postponed by one week again with no adjustment at second vaccine dose.

And while there is no preference for one COVID-19 vaccine over another, with the Task Force advising that patients could receive either vaccine available to them, it did note that AIIRD patients should receive the second dose of the same vaccine, even if there are non-serious adverse events associated with receipt of the first dose.

Patients should also be counselled about the importance of household members and other close contacts undergoing COVID-19 vaccination when and if it becomes available to facilitate a cocooning effect that may help further protect patients, the Panel advises.

The ARA has created its own guidance for patients, which can be found here. The guidance is intended to be a living document that will be updated as more evidence about the COVID-19 vaccine emerges.