A real-world prospective cohort study of immunogenicity and reactogenicity of ChAdOx1-S[recombinant] among patients with immune-mediated dermatological diseases

Abstract

Background Immunogenicity and reactogenicity of COVID-19 vaccines have been established in various groups of immunosuppressed patients; however, studies involving patients with immune-mediated dermatological diseases (IMDDs) are scarce. Objectives To investigate the influence of IMDDs on the development of SARS-CoV-2-specific immunity and side-effects following ChAdOx1-S[recombinant] vaccination. Methods This prospective cohort study included 127 patients with IMDDs and 97 participants without immune-mediated diseases who received ChAdOx1-S[recombinant]. SARS-CoV-2-specific immunity and side-effect profiles were assessed at 1 month postvaccination and compared between groups. Immunological (primary) outcomes were the percentages of participants who tested positive for neutralizing antibodies [seroconversion rate (SR)] and those who developed T-cell-mediated immunity demonstrated by an interferon-γ-releasing assay (IGRA) [positive IGRA rate (+IGRA)]. Reactogenicity-related (secondary) outcomes were the unsolicited adverse reactions and worsening of IMDD activity reflected by the uptitration of immunosuppressants during and within 1 month of vaccination. Results Overall, the SR for the IMDD group was similar to that of participants without immune-mediated conditions (75·6 vs. 84·5, P = 0·101), whereas + IGRA was lower (72·4 vs. 88·7, P = 0·003). Reactogenicity was similar between groups. No severe adverse reaction was reported. By stratifying the participants in the IMDD group according to individual disease, the immunogenicity of the vaccine was lowest in patients with autoimmune bullous diseases (AIBD) (SR 64·5%, +IGRA 62·9%) and highest in patients with psoriasis (SR 87·7%, +IGRA 80·7%). The reverse trend was found for vaccine-related reactions. Immunosuppressants were uptitrated in 15·8% of cases; 75% of these were patients with AIBD. Conclusions Among participants with IMDDs, ChAdOx1-S[recombinant] showed good immunogenicity among patients with psoriasis, but demonstrated lower levels of immunogenicity for patients with AIBD. Some patients, especially patients with AIBD, should be closely monitored as they may require treatment escalation within 1 month postvaccination.

Optimal time for COVID-19 vaccination in rituximab-treated dermatologic patients

“…The negative impact of rituximab on vaccines’ immunogenicity has been demonstrated for many vaccines before the arrival of COVID-19 vaccines ( 27 – 29 ). Despite the differences in dosage and timing of drug administration, most patients who required repeated courses of rituximab treatment, including those with IMDD, have struggled to mount humoral immunity following COVID-19 vaccines ( 8 , 9 , 20 , 30 – 32 ). Attempts to rectify the situation by using more-immunogenic vaccine platforms (e.g., mRNA and viral vector technologies), lowering rituximab dose, or giving additional vaccine doses have not shown promising benefits ( 32 – 36 ).…”

“…This retrospective pilot cohort study screened participants of previous prospective cohort studies conducted in our institutions for eligibility. These studies evaluated either or both humoral and cellular immune responses to various types of COVID-19 vaccines in IMDD patients 28 days post-vaccination ( 20 , 25 ). Adult (≥ 18 years old) patients diagnosed with IMDD or cutaneous manifestations of connective tissue diseases (e.g., systemic lupus erythematosus with cutaneous lupus erythematosus, rheumatoid arthritis with cutaneous vasculitis, dermatomyositis, systemic sclerosis, mixed connective tissue disease) tested for SARS-CoV-2-specific humoral immunity levels after vaccination were included in this study.…”

“…Our previous study showed that rituximab use was associated with non-seroconversion following COVID-19 vaccination among autoimmune bullous disease patients ( 20 ). Avoiding vaccination while rituximab is taking effect, whereby completing vaccination 2-4 weeks before rituximab treatment, is suggested by international practice guidelines ( 21 , 22 ).…”

Risk–benefit profiles associated with receiving Moderna COVID‐19 (mRNA‐1273) vaccine as an additional pre‐booster dose in immune‐mediated dermatologic disease patients with low SARS‐CoV‐2‐specific immunity following the primary series: A prospective cohort study

“…4 Immune-mediated dermatologic diseases (IMDD) patients are among candidates for an extended primary series, as a considerable proportion demonstrated suboptimal responses to the primary series. 5,6 However, risk-benefit profiles of the additional dose in these patients are unavailable.…”

“…20220317008). 6 After informing the WHO guidance, participants chose between not receiving a third dose, receiving an additional dose, or waiting for the booster dose, which was offered as Moderna COVID-19 (mRNA-1273) vaccine. Methotrexate and mycophenolate mofetil were stopped for 1-week postvaccination while other immunosuppressants were continued.…”