Abstract
Background and aim
Although exposure during drug administration and susceptibility to coronavirus disease-19 (COVID-19) infection secondary to immunomodulatory effects constitute potential risks for patients with chronic spontaneous urticaria (CSU) or asthma on omalizumab (OMZ), there is a risk of loss of response following discontinuation of OMZ. There are few studies describing the clinical course of COVID-19 in patients receiving OMZ.
Materials and methods
A total of 103 patients on OMZ were included in the study between February 2021 and January 2022.
Results
Fourteen (13.6%) of the patients participating in the study had SARS-CoV-2 infection, of whom 3 (21.4%) required hospitalization and 11 (78.6%) were treated in an outpatient clinic. During the pandemic, 17 (16.5%) of the patients interrupted their OMZ treatment. Patients on OMZ for six months or less had a lower rate of interruption (2.5%) than those on OMZ for more than 6 months (25.4%). Patients interrupted treatment for the following reasons: 3 (17.6%) had COVID-19, 10 (58.9%) did not attend the hospital visit due to concern about contamination with SARS-CoV-2, and 4 (23.5%) thought that OMZ treatment would facilitate contamination with SARS-CoV-2. After interrupting OMZ, 3 (25%) female patients and 5 (100%) male patients presented no worsening of their symptoms. Three (13%) of the patients on OMZ for asthma and 11 (13.8%) of those on the drug for urticaria had COVID-19 infection. Patients presenting CSU and severe asthma are completely different, with different potential consequences of OMZ interruption. Nine (52.9%) patients had aggravated symptoms following interruption of OMZ treatment. Three of them described worsening of asthma symptoms and a need to increment their maintenance therapy due to asthma exacerbation after nearly three weeks of interruption, and 6 of them had hives and pruritus as urticaria exacerbation nearly four weeks after interruption of OMZ. The asthma patients did not stop their other treatments, including inhaled corticosteroids.
Conclusion
Use of OMZ does not increase the risk of SARS-CoV-2 infection, COVID-19-related pneumonia, or COVID-19-related hospitalization. We advise patients not to interrupt OMZ treatment during the COVID-19 pandemic unless advised to do so by their doctors, and we recommend that they receive instruction concerning self-administration of OMZ to avoid visiting hospitals in the event of a pandemic.
Keywords: COVID-19, Omalizumab, Urticaria, Asthma
Résumé
Buts de l’étude
Bien que l’exposition lors de l’administration du médicament et la susceptibilité individuelle à l’infection par le coronavirus-19 (COVID-19) secondaire aux effets immunomodulateurs soient des risques potentiels pour le patient victime d’urticaire chronique idiopathique (UCI) ou d’asthme recevant de l’omalizumab (OMZ), il existe également un risque de perte de réponse au traitement à la suite de l’arrêt de l’OMZ.
Matériels et méthodes
Un total de 103 patients recevant de l’OMZ ont été inclus dans l’étude entre février 2021 et janvier 2022.
Résultats
Quatorze (13,6 %) patients participant à l’étude ont été victimes d’une infection à coronavirus, 3 d’entre eux (21,4 %) ont été hospitalisés et 11 (78,6 %) ont été traités en ambulatoire. Durant la pandémie, 17 (16,5 %) patients arrêtèrent le traitement par OMZ. Le taux d’arrêt était plus faible (2,5 %) chez les patients recevant l’OMZ depuis 6 mois ou moins par rapport aux patients recevant l’OMZ depuis plus de 6 mois (25,4 %). L’arrêt du traitement était motivé par l’infection COVID-19 dans 3 cas (17,6 %), par une non-fréquentation de l’hôpital par crainte de contagion dans 10 cas (58,9 %), et dans 4 cas (23,5 %) parce qu’ils pensaient que l’OMZ favorisait l’infection COVID-19. Après l’arrêt de l’OMZ, 3 (25 %) femmes et 5 (100 %) hommes n’ont présenté aucune aggravation de leurs symptômes. Trois (13 %) patients recevant de l’OMZ pour asthme et 11 (13,8 %) pour de l’UCI présentèrent une infection par COVID-19. Les patients souffrant d’UCI ou d’asthme sévère étaient totalement différents, avec des conséquences potentielles différentes de l’interruption de l’OMZ. Neuf (52,9 %) patients aggravèrent leurs symptômes à l’arrêt de l’OMZ. Trois d’entre eux décrivirent une accentuation des symptômes d’asthme avec besoin d’augmenter leur traitement de fond pour exacerbation d’asthme après près de 3 semaines d’arrêt, et 6 d’entre eux présentèrent une exacerbation de l’urticaire avec papules et prurit après près de 4 semaines d’arrêt de l’OMZ. Les asthmatiques n’arrêtèrent pas les autres médicaments dont les corticostéroïdes inhalés.
Conclusion
L’OMZ n’augmente pas les risques d’infection par COVID-19, ni les pneumopathies liées à l’infection COVID-19, ni les hospitalisations dues au COVID-19. Nous prévenons les patients de ne pas interrompre leur traitement par OMZ pendant la pandémie par COVID-19 sans avis médical, et nous recommandons une éducation thérapeutique pour l’auto-administration d’OMZ pour éviter les séjours hospitaliers en cas de pandémie.
Mots clés: COVID-19, Omalizumab, Urticaire, Asthme
1. Introduction
Omalizumab (OMZ) is a recombinant humanized monoclonal immunoglobulin G1 (IgG1) anti-IgE antibody approved by the Food and Drug Administration (FDA) for treatment of moderate-to-severe allergic asthma and H1-antihistamine-refractory chronic spontaneous urticaria (CSU) in patients aged 12 years and over. OMZ blocks IgE binding to its high-affinity FcɛRI receptor, resulting in reduction of free IgE. Further, IgE-mediated reactions and downregulation of FcɛRI expression occur. OMZ has additional effects other than its anti-IgE activity; it reduces the duration of rhinovirus infection, improves inadequate antiviral response, and decreases viral shedding, especially in pediatric patients with allergic asthma [1]. OMZ may thus exert protective effects against SARS-CoV-2-like viruses. Although exposure during drug administration and susceptibility to coronavirus disease-19 (COVID-19) infection secondary to immunomodulatory effects constitute potential risks for patients on CSU or asthma patients on OMZ, there is a risk of loss of response following OMZ discontinuation [2].
Although guidelines exist, as well as several case reports [3], [4], [5], stating that OMZ may be used in CSU patients during the COVID-19 pandemic, there are limited studies presenting the clinical course of COVID-19 in patients on OMZ [6]. Continuation of OMZ is recommended in patients with mild-to-moderate COVID-19 infection. In the event of severe disease, recommendation on extending the dose intervals or interrupting treatment is based on individual patient risk-benefit analysis [7].
The aim of this study was, thus, to evaluate the prevalence of COVID-19, to learn the opinions of patients about the effect of OMZ on their COVID-19, and to determine the OMZ interruption rate as well as the clinical course of diseases after treatment interruption in patients treaeted with OMZ.
2. Methods
2.1. Study design
The study included patients aged over 18 years being followed up for OMZ administration by an experienced nurse in a hospital outpatient clinic at a tertiary allergy clinic in Manisa, Turkey, between February 2021 and January 2022. Diagnosis of SARS-CoV-2 was based either on a positive Polymerase Chain Reaction (PCR) test for patients presenting clinical signs consistent with COVID-19 or on consistent computed tomography findings. Participants submitted signed written informed consent forms before enrolment in the study, which was approved by the Manisa Celal Bayar University Ethics Comittee (decision number: 2021/749). A questionnaire was completed to establish the following: demographic data, treatment duration, indications for OMZ, comorbidities, history of COVID-19 infection, patient opinions about the effect of OMZ treatment on their COVID-19, OMZ interruption rate, reasons for interruption, and post-interruption exacerbation of symptoms.
2.2. Statistical analysis
The data obtained were evaluated using descriptive statistics (number, percentage distribution, mean, median, standard deviation, etc.), continuous numerical variables, t-test for independent groups (Mann-Whitney U-test in the absence of normal distribution), and one-way analysis of variance (Kruskal-Wallis test in the absence of normal distribution). Categorical variables were evaluated using a Chi2 test. A P-value < 0.05 was considered statistically significant.
3. Results
A total of 103 patients participated in the study: mean age was 42.76 (±12.9) years, and 71 (68.9%) patients were women. The mean age was 43.61 (±12.26) years for females and 40.88 (±14.35) years for males. Table 1 provides details of comorbidities (including diabetes mellitus, hypertension, asthma, and rheumatological, oncological and thyroid diseases), OMZ indication, COVID-19 infection history, COVID-19 severity, and treatment interruption for study participants. Fourteen (13.6%) study participants had SARS-CoV-2 infection, as diagnosed by PCR test, with 3 patients (21.4%) requiring hospitalization and 11 (78.6%) being treated in an outpatient clinic (Table 1).
Table 1.
General characteristics, OMZ indication, COVID-19 history and clinic, patient opinion concerning the effects of OMZ on their COVID-19 infection, treatment interruption in participants.
| General characteristics (n = 103) | Number of participants (%) |
|---|---|
| Gender | |
| Female | 71 (68.9) |
| Male | 32 (31.1) |
| Comorbidities | |
| (+) | 42 (40.8) |
| (−) | 61 (59.2) |
| OMZ indication | |
| Asthma | 23 (22.3) |
| Urticaria | 80 (77.7) |
| COVID-19 | |
| (+) | 14 (13.6) |
| (−) | 89 (86.4) |
| COVID-19 severity | |
| Mild | 11 (78.6) |
| Severe | 3 (21.4) |
| Patient opinion on the effect of OMZ on COVID-19 | |
| No effect | 90 (87.4) |
| Protective | 8 (7.8) |
| Facilitator | 5 (4.9) |
| Treatment interruption | |
| (+) | 17 (16.5) |
| (−) | 86 (83.5) |
COVID-19: coronavirus disease-19; OMZ: omalizumab.
During the pandemic, 17 (16.5%) patients interrupted their OMZ treatment. Only 1 (5.9%) of patients interrupting their treatment had been using OMZ for 6 months or less, and this population had a lower interruption rate (2.5%) than patients on OMZ for over 6 months (25.4%). The difference was statistically significant (P = 0.005) (Table 2 ).
Table 2.
Comparison of patients interrupting and not interrupting OMZ treatment.
| General characteristics (n = 103) | OMZ interrupted (n = 17) (%) | OMZ not interrupted (n = 86) (%) | P |
|---|---|---|---|
| Gender | 1.000a | ||
| Female | 12 (16.9) | 59 (83.1) | |
| Male | 5 (15.6) | 27 (84.4) | |
| Comorbidities | 0.748a | ||
| (+) | 6 (14) | 37 (86) | |
| (−) | 11 (18.3) | 49 (81.7) | |
| Duration of OMZ usage | 0.005a | ||
| ≤ 6 months | 1 (2.5) | 39 (97.5) | |
| > 6 months | 16 (25.4) | 47 (74.6) | |
| COVID-19 history | 0.698b | ||
| (+) | 3 (17.6) | 11 (12.8) | |
| (−) | 14 (82.4) | 75 (87.2) |
COVID-19: coronavirus disease-19; OMZ: omalizumab.
Continuity correction.
Fisher's exact test.
Most (70.6%) patients interrupted the treatment for 3 months or less. In this study, patients interrupted treatment for the following reasons: 3 (17.6%) had COVID-19, 10 (58.9%) did not attend a hospital visit due to concerns about SARS-CoV-2 contamination, and 4 (23.5%) thought that OMZ treatment would facilitate SARS-CoV-2 contamination.
Of the patients on OMZ, 90 (87.4%) felt that OMZ had no effect on COVID-19 susceptibility, 8 (7.8%) thought that OMZ offered protection, and 5 (4.8%) felt that it was a facilitator for COVID-19.
Three (17.6%) of 17 patients interrupting treatment and 11 (12.8%) of 86 patients not interrupting treatment had COVID-19. While 3 (27.3%) of the female study participants were hospitalized due to COVID-19, none of the males were hospitalized. One (33.3%) patient on OMZ for asthma was hospitalized vs. two (18.2%) patients on OMZ for CSU. None of these patients required admission to an ICU. There was no statistically significant difference in terms of COVID-19 severity and gender, comorbidities, indication for OMZ, or treatment interruption (P > 0.05).
There was no statistically significant difference in term of indications for OMZ and COVID-19 history, patients’ opinions about the effect of OMZ on COVID-19, OMZ interruption rates, or rate of worsening of symptoms following interruption of OMZ treatment (P > 0.05).
Patients presenting CSU are completely different from severe asthma patients, with different potential consequences being entailed for interruption of OMZ. Nine (52.9%) patients had aggravated symptoms on interruption of OMZ treatment. Three patients described exacerbation of asthma symptoms and the need for dose incrementation of their maintenance therapy for this exacerbation after nearly three weeks of interruption, while 6 presented hives and pruritus as urticaria exacerbation after nearly four weeks of interruption of OMZ treatment. Asthma patients did not stop their other treatments, including inhaled corticosteroids.
Eight (88.9%) of 9 patients whose symptoms worsened after treatment interruption had been using OMZ for more than 6 months (P > 0.05). After interruption of OMZ, 3 (25%) female and 5 (100%) male patients experienced no worsening of their symptoms (P = 0.009).
Three (17.6%) of 17 patients interrupting treatment and 11 (12.8%) of 86 patients not interrupting treatment had COVID-19 infection. Two (66.7%) of 3 patients infected with COVID-19 and 7 (50%) not infected with COVID-19 had aggravated symptoms during the period of interruption of OMZ treatment. The difference was not statistically significant (P > 0.05) (Table 3 ). There was no significant difference in terms of OMZ interruption status or reasons for interruption as regards gender or comorbidities in patients interrupting treatment (P > 0.05).
Table 3.
Relationship between symptoms and gender, OMZ indication, COVID-19 history, and comorbidities in patients interrupting OMZ treatment.
| Characteristics (n = 17) | Symptoms increased (%) n = 9 (52.9) |
Symptoms not increased (%) n = 8 (47.1) |
P |
|---|---|---|---|
| Gender | 0.009a | ||
| Female | 9 (75) | 3 (25) | |
| Male | 0 | 5 (100) | |
| OMZ indication | 0.576a | ||
| Asthma | 3 (75) | 1 (25) | |
| CSU | 6 (46.2) | 7 (53.8) | |
| COVID-19 history | 1.00a | ||
| (+) | 2 (66.7) | 1 (33.3) | |
| (−) | 7 (50) | 7 (50) | |
| Comorbidities | 0.131a | ||
| (−) | 4 (36.4) | 7 (63.6) | |
| (+) | 5 (83.3) | 1 (16.7) |
COVID-19: coronavirus disease-19; OMZ: omalizumab; CSU: Chronic Spontaneous Urticaria.
Fisher's exact test.
Three (13%) patients using OMZ for asthma and 11 (13.8%) patients using OMZ for urticaria had COVID-19 infection. There was no significant difference in terms of history of COVID-19 as regards gender, presentation of comorbidities, indication for OMZ and treatment interruption (P > 0.05) (Table 4 ).
Table 4.
Comparison of patients with and without a history of COVID-19 infection.
| COVID-19 history + (%) | COVID-19 history − (%) | P | |
|---|---|---|---|
| Gender | 0.541a | ||
| Female | 11 (15.5) | 60 (84.5) | |
| Male | 3 (9.4) | 29 (90.6) | |
| Comorbidities | 0.841b | ||
| (+) | 5 (35.7) | 9 (64.3) | |
| (−) | 38 (42.7) | 51 (57.3) | |
| OMZ usage duration | 0.253b | ||
| ≤ 6 months | 3 (7.5) | 37 (92.5) | |
| > 6 months | 11 (17.5) | 52 (82.5) |
COVID-19: coronavirus disease-19; OMZ: omalizumab.
Fisher's exact test.
Continuity correction.
Regarding groups of patients using OMZ for ≤ 6 months vs. those using OMZ for > 6 months, 40 (38.8%) had been on OMZ for ≤ 6 months while 63 (61.2%) had been on OMZ for > 6 months. However, there was no statistically significant difference in COVID-19 infection rates between these two groups. Three (7.5%) patients in group 1 and 11 (17.5%) in group 2 presented COVID-19 infection (P > 0.05) (Table 4).
4. Discussion
Several groups of patient with chronic diseases interrupted their treatment for various reasons during the COVID-19 pandemic. OMZ is usually administered subcutaneously every 28 days and regular hospital visits are thus required. Failure to attend such visits may result in interruption or discontinuation of treatment.
The present study led to five clinically important findings. First, during the COVID-19 pandemic, 17 (16.5%) of the 103 participants in this study interrupted their treatment for different reasons. Second, the main reason (58.8%) for treatment discontinuation was failure to attend a hospital visit because of concern about being infected with SARS-CoV-2 and patients’ opinion that OMZ treatment might facilitate infection with SARS-CoV-2 (23.5%). Third, the majority (70.6%) of patients interrupted treatment for 3 months or less. However, most patients (52.9%) interrupting their treatment presented exacerbation of their symptoms during this period. Most patients (88.9%) whose symptoms worsened after treatment interruption had been on OMZ for more than 6 months. Fourth, while exacerbation of symptoms occurred in male patients, 25% of female patients experienced no worsening of symptoms after treatment interruption. Finally, patients on OMZ for 6 months or less (2.5%) were less likely to interrupt their treatment during the COVID-19 pandemic than those using OMZ for over 6 months (25.4%).
During the pandemic, 16.5% of study participants interrupted their OMZ treatment. Similarly, in a study of 36 patients in Turkey, 11.1% of patients interrupted their OMZ treatment during the pandemic [8]. In a correspondence report, the majority of patients with CSU did not stop using their medications [9]. Another study from Turkey reported that 44.1% of patients using OMZ discontinued their treatment during the pandemic. Since 194 patients were included in this study and as it was conducted in a crowded city like Istanbul, rates of failure to attend a clinic and of interruption of OMZ treatment may have been higher than in our patients [10].
In the present study, the main reasons for treatment discontinuation were concerns about SARS-CoV-2 contamination and limited access to the clinic. In many countries, OMZ can be self-administered at home without any need for hospital visits. Although the literature states that self-administration is time-saving and cost-effective, we have no experience of self-administration at our clinic [11]. We should therefore switch to self-administration at home during SARS-CoV-2 infection at our clinic. As the second reason, it was determined that patients have an opinion about OMZ treatment would facilitate the SARS-CoV-2 infection. Limited access to a clinic and concerns about SARS-CoV-2 contamination are also described in the literature as reasons for OMZ discontinuation [10].
In a study conducted in around 400 patients with CSU, the disease activity scores of male patients were found to be higher during the pandemic than before the pandemic. Further, disease control was found to be lower in males [12]. In our study, 52.9% of patients interrupting their treatment were found to have experienced exacerbation of their symptoms during the pandemic. Interestingly, all of these patients were female. The reasons for better disease control in males in our study may be explained by the limited population and by the fact that the number of males was less than half that of females. This issue should be clarified by new studies in larger populations.
Similar numbers of patients using OMZ for asthma (13%) and CSU (13.8%) had COVID-19 in our study. Three study participants (21.4%) interrupted their treatment because they had COVID-19. Worsening of urticarial symptoms was detected in 2 (66.6%) of patients interrupting their treatment due to SARS-CoV-2 infection. While all male patients participating in the study received outpatient treatment during SARS-CoV-2 infection, 27.3% of female patients were hospitalized for COVID-19. This may be due to the lower number of males than females. While 1 (33.3%) of the patients using OMZ for asthma was hospitalized, 2 (18.2%) of the patients using OMZ for CSU were hospitalized. None of the patients required admission to an ICU. This difference could be explained by hospitalization for exacerbation of asthma in the context of SARS-CoV-2 infection. An international cross-sectional, multicenter study reported that 26 of 79 CSU patients were using OMZ while presenting COVID-19 and that 92% of these 26 patients had mild symptoms of COVID-19. No statistically significant relationship was detected between COVID-19 severity and CSU treatment [13].
Three (13%) patients using OMZ for severe asthma had COVID-19 in our study. Similarly, in a retrospective study in Turkey, COVID-19 incidence was 18% in patients with severe asthma and 14.66% in patients on OMZ for severe asthma [14]. The incidence of COVID-19 was 19% in 75 patients with asthma on OMZ or mepolizumab, with a higher incidence being seen in patients interrupting their biological treatments in another study in Turkey. In their conclusion, the authors state that severe asthma may be a risk factor for COVID-19 [15].
The majority (87.4%) of patients using OMZ felt that OMZ was not associated with COVID-19 at all. In this study, 83.5% of patients continued using OMZ without interruption during the pandemic. However, 12.8% of patients who did not interrupt treatment had SARS-CoV-2 infection. In a study in 184 patients on OMZ for asthma or CSU, none of the participants tested positive for SARS-CoV-2 [16]. Another study reported that 15 (9.6%) of 233 patients with CSU tested positive for SARS-CoV-2, with 2 patients being hospitalized due to complications of SARS-CoV-2 [17]. Further, in another study, 11 (13.9%) of 79 patients with CSU who had COVID-19 were hospitalized (3 with severe symptoms and 8 with mild symptoms) [13]. Similarly, in our study, 13.6% of patients had COVID-19 infection, of whom 78.6% were treated in outpatient clinics and 21.4% required hospitalization.
In a study investigating the impact of COVID-19 pandemic on management of CSU patients, none of the patients using OMZ tested positive for SARS-CoV-2 [10]. In a retrospective cohort study of 36 adult CSU patients treated with OMZ, only 2 patients using OMZ tested positive for SARS-CoV-2; one had a mild upper respiratory infection and the other had moderate pneumonia [8]. According to these data, OMZ does not appear to increase the risk of SARS-CoV-2 infection in CSU patients. This situation may be explained in terms of the antiviral effects of OMZ. The antiviral mechanism may have been blocking the pro-inflammatory cytokines resulting in antiviral effects. Cross-linking of IgE bound to FcɛRI on plasmacytoid dendritic cells (pDCs), which are mainly located in lung interstitium, is known to diminish IFN-α antiviral response. OMZ binds to free IgE, preventing binding of IgE to FcɛRI, and reducing expression of FcɛRI, thereby increasing IFN-α antiviral response [18]. Further, OMZ inhibits activation of mast cells and directly reduces levels of free IgE. On the other hand, the drug prevents interaction of IgE with FcɛRI and FcɛRII/CD23 located on the surface of structural airway cells and different types of immune/inflammatory cells [19], [20]. OMZ blocks the release of inflammatory agents such as histamine and protease, as well as pro-inflammatory cytokines such as IL-1, IL-6 and IL-33, by affecting mast cells [21]. Furthermore, in an experimental study OMZ was shown to reduce cytokines such as IL-1β, IL-6 and tumor necrosis factor (TNF)-α, which are also responsible for the cytokine storm caused by COVID-19 [22]. Conversely, OMZ decreases toll-like receptor 7 expression, which decreases IFN-α response and that negatively regulates innate immunity [23].
As a result, OMZ reduces free IgE that can induce the allergic cascade, helps reduce asthma-related emergency visits, the need for oral corticosteroids and the risk of severe exacerbations, while providing a significant improvement in symptoms, quality of life (QoL) and lung function [18].
Three CSU patients receiving OMZ treatment were presented in a correspondence report in which two patients were diagnosed with pneumonia and one was diagnosed with upper respiratory tract infection due to COVID-19. None of them discontinued their OMZ therapy and no exacerbations of urticaria were seen [9]. The other report in which seven CSU patients under OMZ therapy were included, none of the patients discontinued OMZ while presenting COVID-19. All of these patients were either asymptomatic or had only mild symptoms of COVID-19. No relapse of urticaria has been seen during COVID-19 [3]. In another study, 65% of patients took H1-antihistamine treatment while the remaining 35% were given a second-line treatment (40.3% OMZ, 53% prednisolone and 4.8% cyclosporine). One of 10 patients using OMZ vs. 1 of 2 in the group of patients treated with H1-antihistamine alone while presenting COVID-19 reported exacerbation of their urticaria symptoms [24]. Similarly, in our study, there was no significant difference concerning exacerbation of symptoms between patients with COVID-19 and those without. Consequently, exacerbation of urticaria was not a common finding in patients with CSU and receiving OMZ while presenting COVID-19.
Finally, patients receiving OMZ for 6 months or less (2.5%) interrupted their treatment less frequently during the COVID-19 pandemic than those using OMZ for more than 6 months (25.4%). This could be related to a hitherto uncontrolled disease (very recent introduction of OMZ) or low expectations of patients using OMZ for more than 6 months that the drug will be effective. Also, we feel that patients would benefit from more recent patient instruction regarding their treatment.
5. Conclusion
In conclusion, first, our study shows that use of OMZ does not appear to increase the risk of SARS-CoV-2 infection, COVID-19-related pneumonia or COVID-19-related hospitalization. However, case-control studies are needed to be able to establish this accurately. Second, we advise patients not to interrupt OMZ treatment during the COVID-19 pandemic unless their doctors advise it, and we recommend that they receive instruction on self-administration of OMZ to avoid the need for hospital visits in the event of a pandemic.
6. Limitations
The main limitation of the study was its limited population and the fact that the number of males was less than half that of females. In addition, retrospective design, lack of a control group and inclusion of data from a single center constituted further limitations.
Funding
Authors declare that they have no sponsor in the study design, in the collection, analysis and interpretation of data; in writing of the manuscript; and in the decision to submit the manuscript for publication.
Disclosure of interest
The authors declare that they have no competing interest.
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