An evidence-based guide to SARS-CoV-2 vaccination of patients on immunotherapies in dermatology

Gresham, Louise; Marzario, Barbara; Dutz, Jan P.; Kirchhof, Mark G.

doi:10.1016/j.jaad.2021.01.047

Cited by 42 publications

(72 citation statements)

References 155 publications

(138 reference statements)

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“…Studies examining vaccine responses with concomitant immunomodulatory treatment are relevant to the ongoing COVID-19 pandemic. In light of the new SARS-Cov-2 vaccines, a recent review 18 suggests that most concomitantly administered biologics are associated with appropriate antibody responses to all vaccine subtypes, a conclusion supported by the data presented here and by a similar trial of an anti-IL-4/anti-IL-13 biologic. 13 The effect of tralokinumab on vaccines against viral-borne diseases (such as influenza), however, was not examined, which may be an area for future study to inform vaccination programs and guidelines.…”

Section: Discussionsupporting

confidence: 65%

Tralokinumab does not impact vaccine-induced immune responses: Results from a 30-week, randomized, placebo-controlled trial in adults with moderate-to-severe atopic dermatitis

Merola

Bagel²,

Almgren

et al. 2021

Journal of the American Academy of Dermatology

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Background: Atopic dermatitis (AD) is a chronic inflammatory skin disease. Interleukin (IL) 13 is a type 2 cytokine that is key to the inflammation underlying AD. Tralokinumab is a first-in-class, fully human, monoclonal antibody that specifically binds with high affinity to IL-13, neutralizing it in AD. Immunomodulatory treatments may impair vaccine-induced immune responses.Objective: Assess the immune responses to standard vaccines in adults with moderate-to-severe AD who are undergoing treatment with tralokinumab.Methods: ECZema TRAlokinumab Trial No. 5 (ECZTRA 5; NCT03562377) was a phase 2, double-blind, randomized, placebo-controlled trial taking place over 30 weeks. Eligible adults were randomized 1:1, with 107 patients receiving tralokinumab 300 mg and 108 patients receiving a placebo every 2 weeks for 16 weeks. All patients received Tdap (tetanus/diphtheria/pertussis) and meningococcal vaccines at week 12. The primary end points were positive antitetanus and antimeningococcal responses between weeks 12 and 16 (noninferiority margin, À25%; responder, [3-fold increase in IgG). Results:The noninferiority of tralokinumab versus placebo for immune response to Tdap (91.9% vs 96.1%) and meningococcal (86.0% vs 84.2%) vaccines was demonstrated at week 16. During treatment, the rates of adverse events were lower for tralokinumab than for the placebo, with most events being mild or moderate.Limitations: Responses to other vaccines (including influenza) were not examined.Conclusions: Treatment with tralokinumab 300 mg every 2 weeks did not affect immune responses to Tdap and meningococcal vaccines. Treatment was well tolerated when administered concomitantly with the vaccines and demonstrated a safety profile comparable to phase 3 trials.

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Section: Discussionsupporting

confidence: 65%

Tralokinumab does not impact vaccine-induced immune responses: Results from a 30-week, randomized, placebo-controlled trial in adults with moderate-to-severe atopic dermatitis

Merola

Bagel²,

Almgren

et al. 2021

Journal of the American Academy of Dermatology

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“…Up to 20 mg/day of prednisone seems to not have any effect on patients' immune response to vaccines. For the COVID‐19 vaccine, it is speculated that regardless of the type of vaccine, systemic corticosteroids have “no or minimal risk” in patients' immune response 4 …”

Section: Figurementioning

confidence: 99%

Leukocytoclastic vasculitis flare following the COVID‐19 vaccine

et al. 2021

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“…Although clinical efficacy of COVID vaccine in immunocompromised patients was unknown, many societies had recommended vaccination of this highly vulnerable patient population. [6] , [7] , [8] , [9] It has been suggested, based on circumstantial evidence, that it is prudent to vaccinate immunocompromised subjects since the benefits outweigh the risks. 10 , 11 However, a recent study reported that only 17% of organ transplant recipients developed detectable antibody to SARS-CoV-2 spike protein after the first dose of mRNA vaccines.…”

Section: Introductionmentioning

confidence: 99%

Analysis of antibody responses after COVID-19 vaccination in liver transplant recipients and those with chronic liver diseases

Thuluvath

Robarts

Chauhan

2021

Journal of Hepatology

135

192

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Background &Aims Liver transplant (LT) recipients or other immunocompromised patients were not included in the registration trials of vaccine studies against SARS-CoV-2. Although clinical efficacy of COVID vaccines in immunocompromised patients was unknown, many societies had recommended vaccination of this highly vulnerable patient population. Methods In this prospective study, we determined antibody (Ab) response to spike protein, 4 weeks after the 2 nd dose of mRNA vaccines or after the single dose of Johnson & Johnson vaccine, in LT recipients and those with chronic liver diseases (CLD) with and without cirrhosis. Results Of the 233 patients enrolled so far, 62 had LT, 79 had cirrhosis (10 decompensated) and 92 had CLD without cirrhosis. Ab titers were defined as undetectable (<0.40 U/mL), suboptimal (0.40 - 250 U/mL) and adequate (>250 U/mL). Of the 62 patients who had LT, Ab levels were undetectable in 11 patients and suboptimal (median titer 17.6, range 0.47 - 212 U/mL) in 27 patients. Among 79 patients with cirrhosis, 3 had undetectable Ab and 15 had suboptimal (median titer 41.3, range 0.49 - 221 U/L) response. Of the 92 patients without cirrhosis, four had undetectable Ab and 19 had suboptimal (median titer 95.5, range 4.9 - 234 U/L) Ab response. Liver transplantation, use of 2 or more immunosuppression medications and vaccination with a single dose of Johnson & Johnson vaccine were associated with poor immune response on multivariable analysis. No patient had any serious adverse events. Conclusions Poor antibody response after SARS-CoV-2 vaccination was seen in 61% of LT recipients and 24% of those with CLD. Lay summary The clinical efficacy of COVID vaccines in immunocompromised patients is unknown. We did a prospective study to evaluate immune responses to COVID vaccines (Moderna, Pfizer or Johnson & Johnson) in 62 liver transplant recipients, 79 subjects with cirrhosis and 92 subjects with chronic liver diseases without cirrhosis. We found that 17.8% of liver transplant recipients, 3.8% of those with cirrhosis and 4.3% of those with chronic liver diseases without cirrhosis had undetectable antibody levels. In total, 61.3% of liver transplant recipients and 24% of those with chronic liver diseases (with or without cirrhosis) had poor antibody response (undetectable or suboptimal). Liver transplantation, use of immunosuppressive medications and vaccination with a single dose of Johnson & Johnson vaccine were associated with poor antibody response when adjusted for other factors.

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An evidence-based guide to SARS-CoV-2 vaccination of patients on immunotherapies in dermatology

Cited by 42 publications

References 155 publications

Tralokinumab does not impact vaccine-induced immune responses: Results from a 30-week, randomized, placebo-controlled trial in adults with moderate-to-severe atopic dermatitis

Tralokinumab does not impact vaccine-induced immune responses: Results from a 30-week, randomized, placebo-controlled trial in adults with moderate-to-severe atopic dermatitis

Leukocytoclastic vasculitis flare following the COVID‐19 vaccine

Analysis of antibody responses after COVID-19 vaccination in liver transplant recipients and those with chronic liver diseases

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