Friday January 29th 2021, 2:30-3:30 PM CET
Attending: Esther Freeman USA (AAD/ILDS registry), Jo Lambert Belgium (SPIN), Amy Paller USA (IEC), Carle Paul France (EADV), Alain Taieb France (ISAD), Andreas Wollenberg Germany (ISAD/ETFAD), Christian Vestergaard Denmark (ETFAD), Andrea Chiricozzi Italy (DA-COVID registry), Ketty Peris Italy (DA-COVID registry), Alan Irvine Ireland (Study Lead), Carsten Flohr UK (Study lead), Phyllis Spuls NL (Study lead), Angela Bosma NL, Conor Broderick UK, Ching-Chi Chi Taiwan, Aaron Drucker Canada, Kenji Kabashima Japan, Annelie Musters NL, David Prieto-Merino Spain (Statistician), Dmitri Wall Ireland, Bernd Arents NL (Patient Representative)
Not attending: Sébastien Barbarot France (ETFAD), Emma Guttman USA (IEC), Tamar Nijsten NL (EDEN), Tim Burton UK (Patient Representative)
Welcome
AI welcomed all attendees.
Action points from last meeting:
- AC/KP to promote SECURE-AD through the Italian Society of Dermatology – THANK YOU!
- SECURE-AD Steering Group to send out email to all SECURE-AD Patients Registry participants to encourage them to contact the team if they experienced an infection episode since registration (if they were not infected at baseline) – DONE
- AM to provide the social media picture to EF and the rest of the ISAC – DONE
- EF to use social media compatible picture for forthcoming COVID derm webinars and other promotion opportunities – DONE
- SECURE-AD team to devise a concerted effort to engage with pharma companies to upload trial patient data – DONE (main contacts Leo, Lilly, Pfizer, Galderma, Abbvie, Sanofi)
- CV to include information on SECURE-AD in ETFAD newsletter in November and to mention SECURE-AD at the ETFAD Board meeting in October – DONE
Latest data from the SECURE-AD physician registry
CF: Current registration numbers: SECURE-AD physician registry: 244, SECURE-AD patients survey: 565 (diagnosed/suspected COVID-19: 209). CF walked the attendees through the current results of the SECURE-AD physician registry data.
JL mentioned that patients on topical treatment only could serve as a control group, good to promote this and try to recruit more patients on topical treatment.
JL asked if patients report that they stop their systemic treatment during COVID infection, she sees that patients stop their treatment without consulting their physician. CF: these numbers seem to be small, but the Patient Survey can possibly give a better answer to this. AW: the advice (from ETFAD) is to continue treatment). AW mentioned that he has not seen any COVID cases in his AD patients on systemics, could there be a protective factor? CF: PsoProtect is investigating this question. CF: shielding behavior could also be an explanation or maybe there is some degree of protection because of the disease itself.
AT mentioned that the population may be biased (patients with mild disease severity on systemic treatment): is the treatment influencing the disease? Is the disease influencing the COVID outcomes? Is it the disease itself preventing from COVID? Or is it the treatment? CF: you’ll need a very large power to answer these questions.
Patient recruitment
CF mentioned that there are only 3 patients from Spain in the registry. AC: hard to encourage dermatologists to report a case. In the first wave, people were more motivated. Personal emails seem to work better.
AP mentioned that she has not seen a single pediatric AD patient with COVID. She will approach the Medical Dermatology Society. She will also reach out to adult team and encourage them to recruit adult patients.
CV has seen 1 patient with AD and COVID so far, however he thinks there must be some new patients who have contracted COVID coming for follow-up visits now.
Publication plans
CF: Currently analysis for publication is being deferred to maximise recruitment during this wave of pandemic. When should we aim to publish? Extract and analyse at certain threshold of patients registered?
CF: Currently n = 244, average 1.3 patients registered/day (Jan 2020). Extract and analyse at n > 300 (estimate 1-2 months) or > 400? Or plan to analyse at a fixed timepoint?
AP suggested to wait for n > 300 patients. However, if you wait too long, journals may not be interested to publish anymore.
AC: if the rate of inclusion is still high, then wait. When activity decreases: publish.
AT mentioned that the number of COVID cases should be high, proven diagnosis is important. AI said that many cases from Italy in March where non-PCR diagnoses.
Adding vaccination questions in the physician and/or patient registry?
CF talked about the pros and cons to including vaccination questions and the potential strategies to do this.
CF: should we look at patiens’ perspective on vaccine safety? Reasons to not take the vaccine? Incorporate questions in both registries? Our preference is to incorporate questions into the Patient Survey. Should we also include patients who haven’t had COVID?
AP mentioned that the inclusion rate of patients who get a vaccine can be quite high, as everyone will receive one.
AW: could there be a problem with legal authorities if we ask questions on efficacy?
CF: we will not ask substantive questions about the vaccine itself; the focus will be on patients’ considerations and self-reported adverse events. Cave: biased to capture patients who got an allergic reaction to the vaccine.
CV: not sure if it will give any useful information. Highly selected group. Not sure if it will produce any useful knowledge. What questions will be answered by putting in these questions? It will be very Soft data
AD: I agree that the detail of question is limited. Useful information with the regard on eczema flare etc. However, if you capture people who get adverse reactions, it’s worth adding them.
KP: I will put effort in capturing side effects in such patients. Local + systemic reactions. Specific questions for these patients and ask for their perception of vaccination.
EF: AAD/ILDS registry is already capturing data on vaccination reactions. Now >100 patients. Huge range of patients, however there is a checkbox for AD. Happy to share data from AD patients.
EF: what is the goal of capturing this data? My goal is to characterize the possible skin reactions, not the incidence. Healthcare providers will be the first to get a vaccine, so people that were reporting reactions are healthcare providers. Different group than population just reporting skin manifestations of COVID. There will be different “waves” of populations getting the vaccine.
JL: IBD/Rheum/Derm research is also going on: COVID immunity / biobanking on vaccination. Now >1000 patients (different IMIDs). Easily sharable if needed. Clinical data is being collected.
CF: should we have a separate discussion on this?
PS mentioned that we should collect the different research initiatives + list them on the website, so people can connect. In the Netherlands we collect data on vaccination status in patients with IMIDs looking at different treatment groups.
Closure – Phyllis Spuls
PS closes meeting and PS/CF/AI thanked everyone for joining this meeting.
We decided that the next meeting will be planned in +/- 3 months’ time.
Action points
- ALL: to email colleagues personally and remind them to report cases of COVID-19 in their patients with AD. Also mention that cases can be entered retrospectively.
- AP: to reach out to adult team (colleagues) and encourage them to recruit adult patients.
- SECURE-AD team: to extract and analyse data at n > 300
- SECURE-AD team to look further into whether or not to add vaccination questions to the Patients Survey
- SECURE-AD team to collect different existing research initiatives on COVID vaccinations in (among others) AD patients and to publish on SECURE-AD website.