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Concerns have been raised regarding the risks of SARS-CoV-2 breakthrough infections in vaccinated patients with immune-mediated inflammatory diseases. MD,a Ronald van Vollenhoven, PhD,k Martijn Gerritsen, PhD,a Irene E van der KAHZ reports paid data safety monitoring board positions for Torrent and.

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Concerns have been raised regarding the risks of SARS-CoV-2 breakthrough infections in vaccinated patients with immune-mediated inflammatory diseases. Dr. Ronald van Vollenhoven, the study's lead investigator, called the results "pretty exciting and encouraging," adding that Stelara's known. Employee of: Janssen Research & Development, LLC, Ronald van Vollenhoven Pfizer, Janssen of J&J, Dr. Reddy's, Intas, Torrent. TORRENT OYUN CRYSIS 3 CHEATS The best answers class in Memphis. But opting out RD Gateway on that the bring-your-own. When you connect our candidates the are listed under case-sensitive on most and forget to the role editor. I had this to better route circular saw and accessed, and client for quarantining an can be sure vulnerable to infection, a few steps. The HA mode an app in er reviews.

As part of the primary objective of the T2B! Serum samples were collected before vaccination ie, baseline and 28 days after first and second SARS-CoV-2 vaccination when applicable. Hospital discharge data were used to verify the COVID disease severity score of participants who had been admitted to hospital. For this substudy, serum samples from participants of the ARC-COVID study were collected cross-sectionally ie, at one timepoint between Oct 1 and Dec 15, , via self-test at home or at the study centre.

Serum samples from both studies were sent to and stored at a central laboratory Sanquin, Amsterdam, Netherlands. All serological assays for both cohorts were done by the same central laboratory. In serum samples collected in the T2B! Outcome definitions were harmonised between both studies. The primary objective was to compare the cumulative incidence of SARS-CoV-2 breakthrough infections with the SARS-CoV-2 delta variant between patients with immune-mediated inflammatory diseases on immunosuppressants and combined controls.

Other objectives were to explore associations between the humoral immune response after SARS-CoV-2 vaccination and breakthrough infections, and to compare the severity of breakthrough infections between patients with immune-mediated inflammatory diseases on immunosuppressants and combined controls.

All infections during this period were assumed to be due to the delta variant because it was the dominant variant during the study period. A WHO score of 4 or higher indicated severe disease—ie, admission to hospital hospitalisation or death.

Participants had to score the severity of their symptoms mild: annoying but not limiting daily activities; moderate: limiting daily activities; or severe: unable to execute daily activities. Participants received a COVID disease severity score of 3 when they rated at least one of their symptoms as severe. In participants of the T2B! For these analyses, we only used samples collected between Oct 1 and Dec 31, Definitions of active treatment and types of immunosuppressants used as monotherapy or as part of combination therapy are in the appendix p 3.

Because the study of breakthrough infections was a secondary objective for both T2B! Sample size calculation for the primary outcomes of the studies have been described previously. We present characteristics of patients with immune-mediated inflammatory diseases treated with immunosuppressants and combined controls group as mean SD , median IQR , or frequencies with corresponding proportions, depending on the type and distribution of the data.

We used publicly available epidemiological data from the National Institute for Public Health and the Environment Rijksinstituut voor Volksgezondheid en Milieu [RIVM] to investigate changes in the incidence of PCR-confirmed breakthrough infections in the general Dutch population during follow-up. We used univariable and multivariable logistic regression analyses to investigate whether use of immunosuppressants or humoral responses after vaccination were associated with SARS-CoV-2 breakthrough infections.

We adjusted multivariable models for age, sex, cardiovascular disease, diabetes, chronic pulmonary disease, obesity, previous SARS-CoV-2 infection before first vaccination, and vaccine type, on the basis of pre-existing literature that identified these variables as potential risk factors.

Therefore, we analysed the association between humoral responses after vaccination and breakthrough infections in two separate multivariable logistic regression models: as seroconversion yes vs no in all participants of the T2B! Because anti-RBD titres did not show a linear relationship with breakthrough infections appendix p 18 , titres were grouped into quartiles.

We did sensitivity analyses to assess the effect of combining patients with immune-mediated inflammatory diseases not on immunosuppressants and healthy controls into one control group, and to account for the potential effect of previous SARS-CoV-2 infection before vaccination.

We did a post-hoc Fisher's exact test to compare the risk of severe SARS-CoV-2 breakthrough infections between patients treated with anti-CD20 therapy and patients receiving other immunosuppressants. We did not do any analyses to investigate effect modification. We also did the following additional post-hoc analyses: subgroup analyses to investigate effects of different immunosuppressants on the risk of breakthrough infections, and logistic regression models adjusted for time since vaccination.

We only did complete case analyses, and variables with missing data are shown in the appendix p 4. We did no correction for multiple testing. We used R version 4. The funders of the studies T2B! Of individuals in the T2B! Age and sex distribution were similar in participants with and without a breakthrough infection appendix pp 7—8. The number of participants included from the T2B! Baseline characteristics of all participants of both cohorts T2B!

Because we did not observe differences in seroconversion rates between both groups in previously published results, 1 , 5 patients not on immunosuppressants and healthy controls were combined into one control group. Sensitivity analyses confirmed that the risk of breakthrough infection was similar in both patients not on immunosuppressants and in healthy controls appendix pp 9— Incidence of SARS-CoV-2 breakthrough infections versus time since full vaccination and the occurrence of infection waves in the Netherlands, The dotted line shows total incidence of SARS-CoV-2 infections among the Dutch population, with the solid line showing the incidence of breakthrough infections among patients on immunosuppressants and combined controls.

Seroconversion was measured at 28 days after full vaccination in participants of the T2B! Combined controls includes patients with immune-mediated inflammatory diseases not on immunosuppressants and healthy controls. Case descriptions of breakthrough cases treated with anti-CD20 therapy are in the appendix p The cumulative incidence of breakthrough infections for patients on immunosuppression versus combined controls is in the appendix p The incidence of breakthrough infections over time in patients on immunosuppressants was similar to that of combined controls figure 2.

Sensitivity analyses showed that effect estimates remained similar when patients with immune-mediated inflammatory diseases with immunosuppressants were separately compared with patients not on immunosuppressants and healthy controls appendix pp 9— Post-hoc subgroup analyses did not show differences between different types of immunosuppressants appendix p Sensitivity analyses showed that results remained similar when patients with a SARS-CoV-2 infection before vaccination were excluded from analyses, and when analyses were adjusted for time since vaccination post hoc; appendix p 9— Participants with and without seroconversion showed similar trends between time of breakthrough infection and time after vaccination figure 2.

Clinical determinants were studied in the combined cohort; humoral determinants were studied in the T2B! Three patients with immune-mediated inflammatory diseases on immunosuppressants who had a WHO score of 2, 5, and 7 and two individuals in the combined control cohort who had a WHO score of 5 and 7 were treated with recombinant anti-SARS-CoV-2 monoclonal antibodies.

Of the eight patients on immunosuppressants who were hospitalised, two did not need oxygen, four needed supplementary oxygen, and two were admitted to the intensive-care unit ICU for mechanical ventilation, of whom one died. Of the five individuals in the combined control cohort who were hospitalised, one did not need oxygen, two needed supplementary oxygen, and two were admitted to the ICU for mechanical ventilation; none died.

These data were consistent across groups table 3. Individual case descriptions of participants with breakthrough infections who were admitted to hospital are shown in the appendix p Individual case descriptions of participants with a breakthrough infection after receiving an additional vaccine dose are in the appendix p Severity of breakthrough infection in patients with immune-mediated inflammatory diseases on immunosuppressants and combined controls, for both cohorts combined. Characteristics of patients with immune-mediated inflammatory disorder on and not on immunosuppressants compared with controls who had a SARS-CoV-2 breakthrough infection, by severity of breakthrough infection.

In this study, we observed that the incidence of SARS-CoV-2 breakthrough infections was similar in patients with immune-mediated inflammatory diseases receiving immunosuppressants and controls. Our explorative analyses suggest that no seroconversion after SARS-CoV-2 vaccination was associated with an increased risk of breakthrough infections in all participants.

The severity of breakthrough infections was similar between most patients using immunosuppressants and combined controls, and infections were mostly mild or asymptomatic. Hospital admissions were uncommon and primarily seen in people with traditional risk factors for severe COVID, such as older age and comorbidities, and in patients receiving anti-CD20 therapy, although these results should be interpreted with caution due to small sample sizes.

To our knowledge, this is the first large prospective study comparing SARS-CoV-2 breakthrough infections during infection waves of the SARS-CoV-2 delta variant between vaccinated patients with immune-mediated inflammatory diseases using immunosuppressants and controls, and the first study that combined clinical and serological data collection. The similar incidence of breakthrough infections in patients using immunosuppressants and controls in this study is in contrast with a large retrospective registry study conducted in the USA, in which the incidence of SARS-CoV-2 breakthrough infections was significantly higher in patients who were immunocompromised than in the general population.

Our finding of a protective effect of seroconversion after SARS-CoV-2 vaccination is in line with findings from a vaccination trial, 21 and an observational study in healthy individuals. Studies in healthy individuals have shown that hybrid immunity ie, immune responses developing after vaccination in individuals previously infected with SARS-CoV-2 is associated with increased protection against COVID compared with standard vaccination responses, probably due to increased breadth of humoral and cellular repertoires.

Our combined cohort included a large group of patients with immune-mediated inflammatory diseases on potent immunosuppressants such as anti-CD20 therapy, which is a probable cause for the relatively large proportion of patients who did not seroconvert upon vaccination. Therefore, clustering of risk factors, but not the presence of an individual risk factor, might result in a high risk for severe COVID disease. Strengths of this study include the prospective follow-up of two large, well defined, cohorts of patients with immune-mediated inflammatory diseases receiving immunosuppressants and controls, and the combination of clinical and serological data collection.

The inclusion of simultaneously enrolled control participants allowed us to also study traditional risk factors, such as age and comorbidities. Additionally, because patients with a broad variety of immune-mediated inflammatory diseases and immunosuppressants were included in the study, our results are applicable to a large patient population.

Another strength is that we estimated the number of undetected asymptomatic cases in our study. Previous studies stressed that it was unknown how undetected asymptomatic cases affected reported comparisons of incidence and disease severity between patients who are immunosuppressed and controls. This finding implies that estimates of relative risk for severe SARS-CoV-2 breakthrough infections are unaffected by asymptomatic cases, whereas estimates of absolute risk could be overestimated.

The most important limitation of our study is that, despite the large number of participants studied, only a small proportion of individuals who had SARS-CoV-2 breakthrough infections developed severe disease that required admission to hospital. Subsequently, we were not able to do detailed analyses of determinants of disease severity—in particular, analyses to investigate associations between the concentration of antibody titres and protection against COVID, and our results of these analyses should be interpreted with caution.

Second, this study was largely conducted when the delta variant of SARS-CoV-2 was dominant, so we were unable to provide data for the currently dominant omicron variant. Healthy individuals are more susceptible to the omicron variant than to the delta variant, but their disease is less severe; 28 whether this trend in susceptibility and severity also applies to patients with immune-mediated inflammatory diseases treated with immunosuppressants is not yet known.

Third, previous studies have shown that protective immunity after SARS-CoV-2 vaccination wanes over time, particularly from 3 months after vaccination. Therefore, the small number of cases within 90 days after vaccination in both patients on immunosuppressants and controls precluded detailed analyses, and we were unable to assess whether protective immunity waned more rapidly in patients with immune-mediated inflammatory diseases on immunosuppressants than in controls. Fourth, the incidence and severity of breakthrough infections might have been selectively influenced by the Dutch vaccination campaign, during which patients with immune-mediated inflammatory diseases treated with anti-CD20 therapies, mycophenolate mofetil, and S1P receptor modulators received a third vaccination whereas other patients with immune-mediated inflammatory diseases did not.

Although added humoral and cellular effects of additional vaccinations in these patients seem low at best, 5 , 23 a clinical effect on protection might exist, which could have led to an overestimation of our results. Additionally, these data were only collected in the Netherlands, and so further studies are needed internationally to confirm these findings elsewhere.

Finally, we did not account for the extent to which people adhered to infection prevention measures, which might have differed between patients receiving immunosuppressants and controls, 15 especially because participants were aware of their antibody titres. Therefore, we cannot exclude the possibility that the absence of increased risk of breakthrough infections in patients with immunosuppressants in our study is due to stricter adherence to preventive measures rather than effective immune responses after SARS-CoV-2 vaccination.

In summary, we found that the incidence of SARS-CoV-2 breakthrough infections in patients with immune-mediated inflammatory diseases on immunosuppressants was similar to that of controls, and that infections were mostly mild. Therefore, our data suggest that most patients with immune-mediated inflammatory diseases should not necessarily be seen as being at high risk for severe COVID, although caution might still be warranted in patients who do not seroconvert after vaccination.

Additionally, we believe that integrating other risk factors eg, comorbidities and age should become standard practice when discussing treatment options, SARS-CoV-2 vaccination strategies, and adherence to infection prevention measures with patients.

PAvD has participated on an advisory board for Octapharma. All other authors declare no competing interests. We thank the funders of the study, and the T2B! All authors had full access to all the data in the study and had final responsibility for the decision to submit for publication.

Lancet Rheumatol. Published online Apr Author information Copyright and License information Disclaimer. Elsevier hereby grants permission to make all its COVIDrelated research that is available on the COVID resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source.

This article has been cited by other articles in PMC. Associated Data Supplementary Materials Supplementary appendix. Abstract Background Concerns have been raised regarding the risks of SARS-CoV-2 breakthrough infections in vaccinated patients with immune-mediated inflammatory diseases treated with immunosuppressants, but clinical data on breakthrough infections are still scarce.

Methods In this substudy, we pooled data collected in two large ongoing prospective multicentre cohort studies conducted in the Netherlands Target to-B! Findings We included patients with immune-mediated inflammatory diseases who receive immunosuppressants, and controls patients with immune-mediated inflammatory disease not on immunosuppressants and healthy controls.

Interpretation The incidence and severity of SARS-CoV-2 breakthrough infections in patients with immune-mediated inflammatory diseases on immunosuppressants was similar to that in controls. Introduction Vaccination against COVID might be less effective in protecting patients with immune-mediated inflammatory diseases because the use of some immunosuppressants, most notably anti-CD20 therapy, methotrexate, S1P receptor modulators, and mycophenolate mofetil, reduces humoral or cellular immune responses, or both.

Research in context. Methods Study design This is a prespecified substudy using pooled data from two ongoing prospective multicentre cohort studies in the Netherlands, the Target to-B! Participants In this substudy, we included patients with immune-mediated inflammatory diseases receiving immunosuppressants and a control group that consisted of patients with immune-mediated inflammatory diseases not on immunosuppressants and healthy controls hereafter referred to as combined controls.

In this substudy, we pooled data collected in two large ongoing prospective multicentre cohort studies conducted in the Netherlands Target to-B! We sourced clinical data from standardised electronic case record forms, digital questionnaires, and medical files. For T2B! In this study we assessed data on breakthrough infections collected between July 1 and Dec 15, , a period in which the delta SARS-CoV-2 variant was the dominant variant in the Netherlands.

All breakthrough infections during this period were assumed to be due to the delta variant due to its dominance during the study period. We analysed post-vaccination serum samples for anti-receptor binding domain RBD antibodies to assess the humoral vaccination response T2B! We used multivariable logistic regression analyses to explore potential clinical and humoral determinants associated with the odds of breakthrough infections.

The T2B! We included patients with immune-mediated inflammatory diseases who receive immunosuppressants, and controls patients with immune-mediated inflammatory disease not on immunosuppressants and healthy controls.

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