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SPECIAL ARTICLE
Year : 2022  |  Volume : 67  |  Issue : 3  |  Page : 314
Evidence-based guidelines for SARS-COV-2 vaccination of patients of skin allergic diseases and patients on immuno-therapeutics


1 Department of Dermatology, KPC Medical College and Hospital, Kolkata, West Bengal, India
2 Department of Dermatology, Calcutta National Medical College and Hospital, Kolkata, West Bengal, India
3 Department of Dermatology, Dr. D. Y. Patil Medical College and Hospital, Nerul, Navi Mumbai, Maharashtra, India
4 Skin Care Centre, Rajajinagar, Bengaluru, Karnataka, India
5 Department of Dermatology, Skin Diseases Center, Nashik, Madhya Pradesh, India
6 Department of Dermatology, The Medicity, Medanta Hospital, Gurugram, Haryana, India
7 Max Super Speciality Hospital, Patparganj, New Delhi, India
8 Department of Dermatology, College of Medicine, Sagore Dutta Hospital, Kolkata, West Bengal, India
9 Department of Dermatology, BJ Medical College, Ahmedabad, Gujarat, India
10 Department of Dermatology, Institute of Child Health, Kolkata, West Bengal, India

Date of Web Publication22-Sep-2022

Correspondence Address:
Sandipan Dhar
Department of Dermatology, Institute of Child Health, Kolkata, West Bengal
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijd.ijd_440_21

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   Abstract 


There is a dearth of data regarding the safety and timing of the severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) vaccination of patients on immunosuppressive or immunomodulatory therapies. However, data from other vaccine trials may be extrapolated to get an idea regarding the recommendation of SARS-COV-2 vaccines. All the novel SARS-COV-2 vaccines are non-live, thus ensuring the safety of the vaccines. However, the vaccines may not be able to generate an equipotent immunogenic response in patients receiving immunotherapeutics, in comparison to those who are not. We have attempted to put forward certain statements, with respect to SARS-COV-2 vaccination of patients who are on treatment for different dermatological conditions. However, the risk-benefit ratio must be discussed between the patient and the physician, and the final call should be individualized.


Keywords: Allergic disease, biologics, immunomodulators, immunosuppressives, SARS-CoV-2 vaccine


How to cite this article:
Das A, De A, Godse K, Sangolli P, Zawar V, Sharma N, Girdhar M, Podder I, Shah B, Dhar S. Evidence-based guidelines for SARS-COV-2 vaccination of patients of skin allergic diseases and patients on immuno-therapeutics. Indian J Dermatol 2022;67:314

How to cite this URL:
Das A, De A, Godse K, Sangolli P, Zawar V, Sharma N, Girdhar M, Podder I, Shah B, Dhar S. Evidence-based guidelines for SARS-COV-2 vaccination of patients of skin allergic diseases and patients on immuno-therapeutics. Indian J Dermatol [serial online] 2022 [cited 2022 Sep 29];67:314. Available from: https://www.e-ijd.org/text.asp?2022/67/3/314/356735




Coronavirus Disease 2019 (COVID-19) has taken a serious toll on the physical and mental well-being of society. However, the arrival of the vaccines has shown some light of hope and positivity in the minds of physicians, patients, and the common man.[1] Dermatology is a discipline where the use of immunosuppressive drugs is rampant. Since most of the dermatological conditions being chronic and having a negative impact on the quality of life of the patients, we need to prescribe immunosuppressive drugs for a considerable duration. The purpose of this article is to guide dermatologists regarding the COVID-19 vaccine and the associated management of allergic dermatological conditions like urticaria, angioedema, and atopic dermatitis, around the crucial time zone of vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

A review of the literature was conducted by the members of the Academy of Skin Allergy Research Society. An extensive literature search was performed across different databases (MEDLINE, Embase, and PubMed) using MeSH and non-MeSH keywords (both alone and in combination), such as “SARS-CoV-2,” “COVID-19,” “atopic dermatitis,” “urticaria,” “angioedema,” “vaccination,” “antihistamine,” “prednisolone,” “corticosteroids,” “azathioprine,” “cyclosporine,” “methotrexate,” “apremilast,” “mycophenolate mofetil,” “JAK inhibitors,” “omalizumab,” “biologics,” and “IVIG.” It was followed by a consensus meeting under the effigies of the Academy of Skin Allergy Research Society of India.

This should be remembered that there are plenty of vaccines on board right now (few of them approved and few under trial) and the safety of vaccination will depend on the type of the vaccine, apart from some other factors. Live attenuated vaccines carry the maximum risk to dermatology patients on immunosuppressive drugs, because of the rare chances of conversion of the weakened wild-type virus to the original pathogenic virus. In India, at the time of publication, mainly three vaccines were approved, Covishield, Covaxin, and Sputnik V, of which the former two have already started being delivered in a large number on mass level.

We have reviewed corticosteroids, methotrexate, azathioprine, cyclosporine, mycophenolate mofetil, omalizumab, biologics, and JAK inhibitors in the setting of studies that have evaluated the safety and effectiveness of both, non-viral and live vaccines.[2] The majority of the vaccines are safe in dermatology patients receiving non-biologic systemic immunosuppressive drugs. However, patients on systemic immunosuppressives like azathioprine, cyclosporine, methotrexate, mycophenolate mofetil, or JAK inhibitors may have a decreased immune response and vaccine immunogenicity on account of obvious reasons. Studies have been conducted on organ transplant recipients, who receive high doses of the immunosuppressive drugs, and therefore, it is difficult to comment whether the vaccine immunogenicity in dermatology patients who receive much lower doses of these drugs would be affected or not. As far as biologics are concerned, few serious adverse events have been reported with vaccines.

It is difficult to estimate the risk associated with the SARS-CoV-2 vaccine, till we get sufficient data with respect to real-world evidence. However, we can draw a few conclusions, from the limited trial data for the SARS-CoV-2 vaccines and a review of the literature for dermatology patients on immunosuppressives, immunomodulators, and vaccines.[3]

The statements have been summarized as follows[4],[5]:

Patients who are suffering from urticaria, either acute, chronic spontaneous, or chronic inducible varieties, are safe to take any SARS-CoV-2 vaccine, and their routine management for the same with antihistamines should be continued. They have to be kept under observation for 30 min after vaccination.

Patients who are getting urticaria after the first dose of the SARS-CoV-2 vaccine maybe given a second dose after complete control of urticaria with antihistamines.

Patients who are suffering from atopic dermatitis are safe to take any SARS-CoV-2 vaccine, and their routine management for the same with antihistamines, topical steroids, topical immunomodulators, and phototherapy should be continued without any disruption during the vaccine process.

Patients who are suffering from contact dermatitis are safe to take any SARS-CoV-2 vaccine, and their routine management for the same with antihistamines, topical steroids, and topical immunomodulators should be continued without any disruption during the vaccine process.

Patients who are suffering from episodes of angioedema can be given vaccines once their episodes are under total control, but with adequate protection, in a hospitalized setup.

Patients on any dose of first- or second-generation antihistamines may continue with SARS-CoV-2 vaccination and no modification of doses is required.

The risk-to-benefit ratio may favor immunization in a patient under immunosuppressive therapies if the immunosuppression is low and there is a significant risk of disease development.

In patients using systemic corticosteroids in a dose of prednisone equivalent to <20 mg/day, there is no need to change the vaccination schedule or treatment plan.

Patients on anti-IgE biologics like Omalizumab can be vaccinated with the SARS-CoV-2 vaccine and there is no requirement to change the dosing schedule of such drug.

Patients on biologics (TNF-alpha inhibitors like adalimumab, etanercept, or infliximab) and anti-IL-17 blockers like secukinumab may be safely vaccinated, without significant modification of ongoing immune therapy. It is advisable to withhold the biologics 1 week before and 1 week after the first COVID-19 vaccine dose, and no interruption is required around the second dose of vaccination.

For rituximab, it is prudent to initiate the series of vaccination 4 to 6 weeks before next scheduled rituximab cycle; after vaccination, rituximab may be delayed for 2 to 4 weeks after the final vaccine dose. This should be noted that protective antibody formation following vaccination may be severely impaired if the patient is on rituximab. Given the partial recuperation of B cells after 6 to 10 months, this time period may be preferred for vaccination in an ideal scenario.

For patients on methotrexate, the drug should be withheld for 1 week after each of the two vaccine doses and 2 weeks after single-dose COVID vaccination, provided the disease is well-controlled. Alternatively, the lowest dose possible may be used, for example, 7.5 mg/week.

For patients on cyclosporine, the drug should be withheld for 1 week after each of the 2 vaccine doses. Alternatively, the lowest dose possible may be used, for example, 2.5 mg/kg/day.[6]

No modifications to ongoing immunomodulatory therapy and timing of vaccination are required if the patient is on hydroxychloroquine, apremilast, IVIG, sulfasalazine, leflunomide, azathioprine, and oral cyclophosphamide.

Mycophenolate mofetil is not a contraindication for COVID vaccination but the drug should be withheld for 1 week following each dose of vaccination.

For patients on JAK inhibitors like tofacitinib, diminished production of antibodies following vaccination is reported. An interruption of 2 weeks (1 week before and 1 week after vaccination) may not be sufficient to generate a substantial immune response following vaccination. It is therefore prudent to ensure a treatment-free period of more than 2 weeks. However, real-world evidence needs to be generated.

For patients with atopic dermatitis on dupilumab, we do not expect an attenuation of vaccination-induced immunogenic response; therefore, there is no requirement for modification of drug schedule and/or vaccination.[6],[7],[8]

For patients requiring injectable drugs for the management of dermatological conditions, it is advisable to choose a different anatomical location for vaccination due to the high frequency of local and systemic reactions.[9]

Antibody titers may be checked after vaccination in patients under immunosuppressive or immunomodulatory medications and additional vaccinations may be considered in select cases, if needed, to boost the level of protective antibodies.

Patients who have an earlier history of anaphylaxis to medication or vaccination can only be vaccinated under adequate intensive care infrastructure, in the presence of qualified internists experienced to manage such attacks.

The mRNA vaccines should not be administered to individuals with a known history of severe allergic reactions to any of the components of the vaccine. Polyethylene glycol is one of the ingredients and it is reported to cause anaphylaxis.[10] Patients who had previously shown anaphylactic attack with a particular vaccine in its first dose should not be given the second dose of the same vaccine.

Conclusion: SARS-CoV-2 vaccine subtypes may be considered in dermatology patients receiving systemic immunosuppressives, immunomodulators, and biologics, without significant alteration of ongoing therapy, apart from withholding the medication for 1 to 2 weeks.[11] It is important to remember that low dose immunosuppression does not reduce the production of antibodies, following vaccination. Besides, the risk-benefit ratio must be assessed before vaccination, and the final decision should be individualized based on the severity of the disease and the dose of the drug, on which the patient is put on.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
   References Top

1.
Forni G, Mantovani A. COVID-19 commission of accademia nazionale dei lincei, Rome. COVID-19 vaccines: Where we stand and challenges ahead. Cell Death Differ 2021;28:626-39.  Back to cited text no. 1
    
2.
Zahedi Niaki O, Anadkat MJ, Chen ST. Navigating immunosuppression in a pandemic: A guide for the dermatologist from the COVID task force of the medical dermatology society and society of dermatology hospitalists. J Am Acad Dermatol 2020;83:1150-9.  Back to cited text no. 2
    
3.
Ghazawi FM, Lim M, Dutz JP, Kirchhof MG. Infection risk of dermatologic therapeutics during the COVID-19 pandemic: An evidence-based recalibration. Int J Dermatol 2020;59:1043-56.  Back to cited text no. 3
    
4.
Gresham LM, Marzario B, Dutz J, Kirchhof MG. An evidence-based guide to SARS-CoV-2 vaccination of patients on immunotherapies in dermatology. J Am Acad Dermatol 2021;84:1652-66.  Back to cited text no. 4
    
5.
Soy M, Keser G, Atagunduz P, Mutlu MY, İçaçan OC, Çelik S, et al. A practical approach for vaccinations including COVID-19 in autoimmune/autoinflammatory rheumatic diseases: A non-systematic review. Clin Rheumatol 2021;40:1-13.  Back to cited text no. 5
    
6.
Thyssen JP, Vestergaard C, Barbarot S, de Bruin-Weller MS, Bieber T, Taieb A, et al. European task force on atopic dermatitis: Position on vaccination of adult patients with atopic dermatitis against COVID-19 (SARS-CoV-2) being treated with systemic medication and biologics. J Eur Acad Dermatol Venereol 2021;35:e308-11.  Back to cited text no. 6
    
7.
Patruno C, Stingeni L, Fabbrocini G, Hansel K, Napolitano M. Dupilumab and COVID-19: What should we expect? Dermatol Ther 2020;33:e13502.  Back to cited text no. 7
    
8.
Blauvelt A, Simpson E, Tyring S, Purcell LA, Shumel B, Petro CD, et al. Dupilumab does not affect correlates of vaccine-induced immunity: A randomized, placebo-controlled trial in adults with moderate-to-severe atopic dermatitis. J Am Acad Dermatol 2019;80:158-67.e1.  Back to cited text no. 8
    
9.
Wang C, Rademaker M, Tate B, Baker C, Foley P. SARS-CoV-2 (COVID-19) vaccination in dermatology patients on immunomodulatory and biologic agents: Recommendations from the Australasian medical dermatology group. Australas J Dermatol 2021;62:151-6.  Back to cited text no. 9
    
10.
Banerji A, Wickner PG, Saff R, Stone CA Jr, Robinson LB, Long AA, et al. mRNA vaccines to prevent COVID-19 disease and reported allergic reactions: Current evidence and suggested approach. J Allergy Clin Immunol Pract 2021;9:1423-37.  Back to cited text no. 10
    
11.
Burlando M, Russo R, Cozzani E, Parodi A. COVID-19 “second wave” and vaccines: The dermatologists' perspective. Int J Dermatol 2021;60:889-90.  Back to cited text no. 11
    




 

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