Social and clinical impact of COVID-19 on patients with fibrodysplasia ossificans progressiva

Abstract

Background COVID-19, caused by the SARS-CoV-2 virus, is a severe inflammatory condition. Patients with pre-existing conditions including diabetes, hypertension, and cardiovascular disease are at particularly high risk of complications. Fibrodysplasia ossificans progressiva (FOP) is an ultra-rare and debilitating genetic disorder that is characterized by a pro-inflammatory state, which leads to progressive heterotopic ossification and complications after trauma, including intramuscular vaccinations. To better understand the impact of COVID-19 on patients with FOP, we first examined the social impact of the pandemic using data from the FOP Registry managed by the International FOP Association. We also identified patients with FOP who were exposed to or contracted the SARS-CoV-2 virus, or who received a COVID-19 vaccine, to investigate if patients with FOP were at increased risks of complications from SARS-CoV2 exposure or vaccination. Results Data from 326 individuals in 69 countries in the International FOP Association FOP Connection Registry were examined using patient-reported outcomes measurement information system (PROMIS) global health scale scores. Twenty-six (28.9%) participants aged ≥ 15 years old rated their satisfaction with their social activities and relationships as poor in 2020, which was an increase from 18 (18.9%) in 2019, prior to the SARS-CoV-2 outbreak. Similar trends were noted for physical and mental health in the pediatric population. Frequency of physician visits was not changed, but a larger portion of patients reported missing dental visits in 2020 compared with 2019 (31.5% vs. 41.7%). A second cohort with 32 subjects was tracked after SARS-CoV-2 exposure or vaccination. Ten subjects were positively diagnosed with COVID-19, 15 received a COVID-19 vaccine, and seven had high-risk SARS-CoV-2 exposure but either did not have a confirmed clinical diagnosis or tested negative. Subjects who tested positive for the virus showed no major complications or increased FOP disease activity, though our sample size is very limited. Among the 15 subjects who received a COVID-19 vaccine, using the International Clinical Council on FOP guidelines for prophylaxis with ibuprofen or acetaminophen, only one person experienced flare-like activity at the injection site. Conclusions Patients with FOP showed a significant decrease in social activities that was reflective of the isolation and mobility changes in this debilitated population. In our limited cohort, the majority of the patients with FOP who tested positive for COVID-19 showed no major complications. Also, although limited in sample size, the majority of patients who received a COVID-19 vaccination and followed guidelines from the FOP International Clinical Council tolerated vaccination well. Only one person experiencing flare activity following their injection. Thus, the risks and benefits of COVID-19 vaccination needs to be discussed carefully so as to support informed decisions.

Ilizarov technique for treating elbow stiffness caused by myositis ossificans: A case report

“…Several studies have documented a strong correlation between coronavirus disease 2019 (COVID-19) and the development of ectopic ossification[ 14 , 15 ]. Meanwhile, MO cases have occurred among patients receiving the COVID-19 vaccine[ 16 , 17 ].…”

A follow-up report on the published paper Social and clinical impact of COVID-19 on patients with fibrodysplasia ossificans progressiva

“…During the total of 22 months of observation, we found that vaccination of patients with FOP with the COVID-19 vaccines could be well tolerated, using the guidelines published in our original manuscript [ 1 ] and on the ICCFOP.org website [ 2 ]. ICC FOP guidelines for COVID-19 Vaccine Injections included taking the vaccine through its intended route, taking the vaccine at a location that is already fused, avoiding vaccination sites exposed to pressure (such as the buttocks), being flare-free for at least 2 weeks prior, using the smallest diameter needle available, and taking ibuprofen or acetaminophen before the vaccination and for 48 h after the injection.…”

“…Due to the propensity for post-traumatic flare activity and progressive HO formation characteristic of FOP, we had originally hypothesized that COVID-19 infection and vaccination may have disproportionately negative impacts on people with FOP. Our observations on a small cohort suggest that patients with FOP have similar risks as the general population to COVID-19 infection, and that patients with FOP may be able to tolerate COVID-19 vaccination when treated following a consensus protocol to mitigate flare risk [ 1 ]. Because other vaccinations and viral infections are known [ 4 – 7 ] to be associated with HO formation in patients with FOP, this information should be used to guide individual discussions about risks and benefits for vaccination within the FOP community.…”

“…We previously described 32 subjects with FOP who tested positive for SARS-CoV-2, had a high-risk exposure, or received COVID-19 vaccination that were recruited between July 14th, 2020 and August 23rd, 2021 in a study approved by the UCSF Institutional Review Board [ 1 ]. We showed that patients with FOP who received the COVID-19 vaccination and followed guidelines from the International Clinical Council (ICC) on FOP [ 2 ] generally tolerated the vaccine well.…”