Online survey – Steroid PRO study

Are you being treated with steroids for your rheumatic condition? We need your help to test a new questionnaire about steroid impact on quality of life for people living in the UK, USA or Australia.  

UWE Bristol has launched a study looking  into the impact of rare rheumatic diseases on peoples’ health related quality of life. They have performed in-depth interviews with 60 patients in the UK, USA and Australia to identify the most important impacts of being treated with steroids and how that impacts on peoples’ quality of life. The interview data has been used to develop a questionnaire which should be useful for anyone treated with steroids for their rheumatic disease, e.g. vasculitis, lupus, scleroderma, Sjogren’s, myositis, polymyalgia rheumatica and giant cell arteritis.

The final Steroid PRO questionnaire will be used in clinics or clinical trials to measure the impact of steroids on peoples’ quality of life (and hopefully highlight the true benefits of novel treatments that reduce the need for steroids in the future). 

Here’s the direct link to the survey if you would like to read more or take part: https://bit.ly/3Hqy2GS

Guidance on Covid-19 vaccination for the severely immunosuppressed

As the pandemic continues to develop and new variants emerge, we will be using this article to make sure everyone has access to important information regarding COVID-19 and what it means for people with rare autoimmune rheumatic diseases.

We’ll be updating this post regularly as new data and information emerges.

Background

People with a weakened immune system who are classified as severely immunosuppressed either due to underlying health conditions or medical treatment are being identified and offered a third primary dose of COVID-19 vaccination to help reduce their risk of getting seriously ill. 

It is recommended that the third dose be given at least eight weeks after the second, as part of the primary course of immunisation, but if your GP or consultant believes that a different interval should be offered, because of ongoing treatment or starting treatment which will suppress the individual’s immune system, then this timing may be altered.

The JCVI also recommends a booster dose for this group a minimum of three months (91 days) after the third primary dose.


Eligibility

Who is eligible for a third primary COVID-19 dose? 

Guidance from the Joint Committee on Vaccination and Immunisation (JCVI) recommends that a third dose be offered to individuals aged 12 years and over with severe immunosuppression. 

This includes people who had or have:

  • a blood cancer (such as leukaemia or lymphoma)
  • a weakened immune system due to a treatment (such as steroid medicine, biological therapy, chemotherapy or radiotherapy)
  • an organ or bone marrow transplant
  • a condition that means you have a very high risk of getting infections
  • a condition or treatment your specialist advises makes you eligible for a third dose

Further information about the eligibility criteria for a third dose has been published by the JCVI and is available here

Do I need a third primary dose or a booster dose?

RAIRDA has developed a vaccine flowchart below, in partnership with Versus Arthritis and The Arthritis and Musculoskeletal Alliance (ARMA) to help people work out if they are eligible for for a third dose, booster or neither which is available here.


Getting vaccinated

Included below is all the information someone needs to get vaccinated if they’re severely immunosuppressed.  

How to get your third dose of a COVID-19 vaccine

If you’re eligible for a third dose, your GP or hospital consultant should contact you to let you know. You may also have received a letter from the NHS advising that you may be eligible and to discuss this with your doctor. 

Your doctor will discuss with you how you can get your vaccine. You’ll usually get vaccinated at your local hospital or a local NHS service, such as a GP surgery.

If you are aged 18 or over and have a letter from a GP or hospital consultant confirming your eligibility for a third dose, you can also book your vaccination appointment online through the National Booking System or attend a walk-in vaccination site if you bring the letter with you to your appointment. 

If you are eligible and you do not have a referral letter from your GP or hospital consultant, you can still opt for a walk-in vaccination appointment, but you will need to present relevant medical documentation confirming your condition and have an assessment on site by a qualified healthcare professional. 

It’s important to be aware that not every walk-in site is able to offer vaccination for people who are severely immunosuppressed, so please use the NHS online walk-in site finder to make sure you choose the right site for you. 

Examples of medical evidence that can be used to confirm your eligibility includes, but is not limited to: 

  • A hospital letter describing your condition at the time of your 1st and/or 2nd dose
  • Evidence of prescribed medication at the time of your 1st/2nd dose – either in a hospital letter that describes the medication being prescribed, a prescription copy or a medication box with your name and the date on it

How to get your COVID-19 booster (fourth dose) 

If you are aged 18 and over and have already received a third dose of the vaccine, you should get a booster three months after your third vaccination. 

If you are eligible for a booster, your GP or hospital consultant should contact you to let you know and invite you to book your appointment. Your doctor will discuss with you how you can get your vaccine. You’ll usually get vaccinated at your local hospital or a local NHS service, such as a GP surgery.

If it has been three months since your third dose and you haven’t heard from your doctor yet, you should contact them to discuss your vaccination. 

Alternatively, if you already have a letter from a GP or hospital consultant confirming your eligibility for a third dose, you will be able to get a booster at a walk-in vaccination site if you take the letter with you, subject to assessment on site by a qualified healthcare professional. 

What adjustments are being made to support people who are severely immunosuppressed attending walk-in vaccination appointments?

Vaccination sites have been asked to ensure that appropriate arrangements and reasonable adjustments are in place such as priority lanes to support people who are less able to queue, including those in the severely immunosuppressed cohort. 

New antibody treatments available for immunosuppressed patients

From the 16th December high risk patients (severely immunosuppressed) who have tested positive for COVID-19 and have onset of symptoms in the last 7 days will be able to access new COVID treatments.

Am I eligible?

Patients must meet ALL of the following eligibility criteria:

  • A positive PCR test within the last 72 hours
  • Onset of symptoms of COVID-19 within the last 7 days
  • A member of a ‘highest’ risk group 

You may be at highest risk of getting seriously ill from COVID-19 if you have:

  • Down’s syndrome
  • sickle cell disease
  • HIV or AIDS
  • chronic kidney disease (CKD) stage 4 or 5
  • certain types of cancer
  • had certain types of chemotherapy in the last 12 months
  • had radiotherapy in the last 6 months
  • had an organ transplant
  • a severe liver condition (such as cirrhosis)
  • a rare condition affecting the brain or nerves (multiple sclerosis, motor neurone disease, Huntington’s disease or myasthenia gravis)
  • certain autoimmune or inflammatory conditions (such as rheumatoid arthritis or inflammatory bowel disease)
  • a condition or treatment that makes you more likely to get infections

Eligible patients will be informed by letter or email if they have a condition that may make them eligible to receive these treatments directly, should they test positive. Patients have been advised to contact their consultant or GP if they have not received a letter and believe themselves to be eligible. GPs and Consultants are asked to make an assessment on their eligibility, and if determined they are eligible, to issue them with a copy of the letter. 

Following a clinical assessment by a clinician from a COVID Medicines Delivery Unit (CMDU) the following types of treatments may be offered to patients: sotrovimab (Xevudy) and molnupiravir (Lagevrio).

PANORAMIC study

On 8 December, the UK Government announced that it has made available new COVID-19 treatment options for eligible groups of people through a new study called PANORAMIC (Platform Adaptive trial of Novel antiviRals for eArly treatment of COVID-19 In the Community).

The trial is being sponsored by Oxford University and will be used to study the efficacy of managing COVID-19 in around 10,000 vaccinated or unvaccinated individuals throughout the community, via treatment with antivirals.

Eligible patients will be contacted by the study team or a local healthcare professional (e.g. a GP or a research nurse) about enrolling in the study, or they can sign up directly at the study website: www.panoramictrial.org.

What does the trial involve?

Trial participants will be split into two groups, each of whom will be offered standard NHS COVID-19 care, with one group also receiving the treatment being tested. Currently (December 2021) this treatment is the antiviral Molnupiravir.

Allocation into one group or another will largely be randomised however individuals with the most severe health risks from COVID-19 who are least likely to benefit from vaccination, are exceptions and rather than being randomly assigned treatment they will be offered the antiviral. 

Once involved in the trial, participants will be asked to either complete a daily diary for the 28 days of treatment, or alternatively to receive a phone call on days 7, 14 and 28 from the trial teams to discuss your symptoms.

What treatments are being tested?

Lageviro (or Molunpiravir), is an oral antiviral, given in the form of a tablet which should be taken twice a day. This treatment reduces the risk of hospitalisation or death in non-hospitalised and at risk adults by at least 30%, and works by introducing mistakes into the viruses genetic code which ultimately kill it.

What does this mean for ‘high risk’ patients?

For those at the highest risk from COVID-19, Molnupiravir is accessible even if they are not taking part in PANORAMIC. Sotrovimab will be available to these individuals from the 20th December.

As more treatments are added to the PANORAMIC trial, and become available to those who are most at risk from the virus, and least protected by the vaccine, RAIRDA will keep updating our COVID-19 information with the latest news. 

Are you eligible for a third dose or a booster vaccine?

Third doses of the COVID-19 vaccine are being offered to severely immunosuppressed people, either because of a health condition or treatment.

This is because research has found that people in this group are less likely to have received a good level of protection from their first two doses of the vaccine. A third dose is being offered to this group to try to increase their initial levels of protection.

Booster jabs are being offered to everyone over 18, and some people in other age groups, three months after the last dose of their initial course, whereas a third primary dose should be taken two months after a second Covid-19 vaccination.

We have developed a vaccine flowchart below, in partnership with Versus Arthritis and The Arthritis and Musculoskeletal Alliance (ARMA) to help people work out if they are eligible for for a third dose, booster or neither.

NHS online booking system updated to include third primary dose

We are pleased to see that NHS England have updated the COVID-19 vaccination booking system on their website to include a category for third primary doses. This is a welcome update and follows RAIRDA’s calls to the government to go further in its commitment to protect vulnerable people by developing a self-referral mechanism for third primary doses, when booking a vaccination appointment. 

If you have been informed of your eligibility for a third primary dose of the COVID-19 vaccine by a GP or consultant, you can now book your appointment using the link below.

https://www.nhs.uk/conditions/coronavirus-covid-19/coronavirus-vaccination/book-coronavirus-vaccination/