ABSTRACT
Background: The prevalence of nonadherence to major treatments and the subsequent adverse outcomes in IBD patients during the first wave of COVID-19 pandemic remain scarce Aim: To investigate the risk of early disease relapse in a cohort of IBD patients under immunosuppressants and/or biologics who decided themselves to discontinue their IBD-related major treatments without previous medical advice during the first wave of COVID-19 pandemic Methods: All consecutive patients with inactive IBD under immunosuppressants and/or biologics who acknowledged having withdrawn their major therapy for IBD without previous medical advice during the first wave of COVID-19 (from March 2020 to December 2020) were enrolled. The primary endpoint was the survival rate without disease relapse. Kaplan-Meier curves were plotted for time from inclusion to IBD relapse and a logistic regression model with uni- and multivariate analyses was performed to identify predictors of relapse after drug discontinuation Results: During the study period, among the 862 IBD patients followed as outpatients either treated with infliximab or vedolizumab (outpatient clinics n= 368) or treated with oral azathioprine, adalimumab golimumab or ustekinumab alone or in combination (n= 494), 54 patients (6.2 %) (42 CD, 12 UC, 28 F, median age 36 years) who had discontinued themselves their IBD-related major therapy without previous medical advice were included. The median duration of drug withdrawal was 7.0 weeks (range 2-24) and the median time to relapse was 9.0 weeks (range 4-20). The most treatments withdrawn were adalimumab (n=19), ustekinumab (n=19), azathioprine (n= 12), golimumab (n=1) and a lesser degree infliximab (n=7) eand vedolizumab (n=6). During the median follow-up period of 24 weeks (range 5-42), 22 out of 54 patients (40.7 %) who discontinued their IBD treatment experienced a relapse in whom 6 requiring administration of oral steroids, 4 hospitalization and 2 IBD-related surgery By univariate analysis, past IBD related surgery was identified as the only predictor of disease relapse after drug withdrawal (OR=3.3 CI 95 % [1.08-10.38] Conclusion(s): In IBD patients, major treatment discontinuation by the patients themselves without medical advices during the first wave of pandemic Covid-19 including the lockdown was associated with a substantial risk of disease relapse occurring in around 4 out of 10 patients and subsequent further risk of need for steroids, hospitalization and surgery. Strategies targeting the adherence to therapy and patient's informations about the real risks leading to drug discontinuation are of paramount interest, especially during health crisis to minimize such issues.
ABSTRACT
Background: Case reports of IBD flares after COVID-19 vaccination have been reported. These cases appear to be rare. In a recent study analyzing adverse event rates and impact on clinical activity of IBD after COVID-19 vaccination, the authors reported a rate of IBD reactivation in 2% of cases defined as reactivation of symptoms associated with a change in therapy (Prevent COVID Study) (Weaver et al. IBD 2022). Method(s): Any patient with IBD, followed as an outpatient in our department and having accepted to be vaccinated against COVID-19, was proposed this study. All the patients included in the study had to contact the department if, within one month of receiving the COVID-19 vaccine, they presented a clinical picture suggestive of an IBD relapse. The patients were reviewed in emergency and an assessment of IBD activity was made: Clinical activity score, CRP and/or calprotectin dosage, short endoscopy in case of UC, colonoscopy or MRI in case of CD. The link between vaccine and relapse was defined by the absence of clinical activity for at least 3 months before vaccination and relapse of the disease at the latest within 30 days after vaccination without therapeutic modification in between. Result(s): 231 patients (mean age: 44.6 years, sex ratio M/F=1.1, 43.3% MC) were eligible. 176 patients had at least three doses of vaccine, all with mRNA, and 55 with no more than two doses. 97 patients (42%) were infected at least once with COVID 19, confirmed by PCR after at least one dose of vaccine, all without resorting to hospitalization, resuscitation or death. 29 patients (12.5%) developed IBD after vaccination (43.6% MC, sex ratio=1, 80% of cases after 3 doses of vaccine) after a median time of 8.5 days (5-17 days). Patient characteristics, treatment received, number of vaccinations, or Covid infection were comparable between groups with and without reactivation after COVID-19 vaccine (P=NS). The risk of relapse after vaccination was 29 per 646 vaccine doses (4.4%). Table 1 reports pre-exacerbation treatments and proposed treatment changes as well as medium-term response. For IBD flares, no severe forms, hospitalization or surgery were observed. Fifteen patients were optimized on their treatment and 18 were switched to another treatment. All were put into clinical remission of their disease. In univariate analysis, no clinical parameter (type of IBD, age, sex, smoking), the number of previous vaccinations, a previous infection with covid 19 or the type of treatment was associated with a significant risk of relapse after vaccination. Conclusion(s): The risk of IBD relapse in patients in durable clinical remission is possible after COVID-19 mRNA vaccination but remains low (4%). No risk factors were isolated in this work.
ABSTRACT
Background: In the context of the Sars-Cov2 pandemic, the management of patients with chronic diseases and/or receiving immunosuppressive drugs was of concern due to lack of data to dictate their management. The objectives of our study were to evaluate the characteristics and prognosis of COVID-19 among IBD patients and to study the factors associated with severe COVID-19. Methods: We carried out a multicentre bispective study in 30 French GETAID centres. Participating centres were asked to report all consecutive COVID19 cases occurring in their IBD-cohort between March,1st and December,31st 2020. The cases had to be confirmed by a PCR test, or by a chest CT scan demonstrating COVID19 lesions. In addition to the baseline examination, patients were scheduled for a follow up visit within 3-6 months following their infection. Demographics, disease characteristics, treatments, and the clinical course of IBD were prospectively recorded. Severe COVID-19 was defined as admission to the hospital >1 day and/or use of oxygen therapy and/or death. Predictive factors for developing severe COVID-19 were explored using univariate and multivariate logistic regression. Results: A total of 719 IBD patients with COVID 19 were included;54.2% were women, median age was 42 years, 64.4% had Crohn's disease (CD), and median disease duration was 10.8 years. 13.3% of the patients were active smokers;12.7% had a BMI>30. With respect to the treatment, 72(10%) patients were not on any IBD medication, 75(10.4%) were only receiving 5-ASA, 164(22.8%) received conventional immunosuppressants, and 509(70.8%) biologics.21.6% of the patients developed either diarrhoea in remitters, or an exacerbation of diarrhoea in active patients. IBD treatments were maintained unchanged, suspended or discontinued in 73.4%, 25.5%, and 1.1% of the patients. Over the follow-up period, 13.2% of the patients had a flare. A total of 68 patients developed severe COVID 19, 67(9.3%) were hospitalized for a median duration of 6 days, and 4(0.6%) patients died. In multivariate analysis, age > 50 years (OR: 2.0,CI:1.06-3.72;p=0.031), obesity (OR: 2.01,CI:1.05-4.09;p=0.037), and comorbidities (OR: 3.28,CI:1.76-6.09;p=0.0002) were factors associated with the occurrence of severe COVID 19;while immunomodulatory treatment (biologic and/or immunosuppressant) was a protective factor for developing severe COVID 19 (OR: 0.38,CI: 0.22-0.69;p=0.0012). Conclusion: Rate of severe COVID 19 in this cohort of IBD patients was corresponding to the general population with similar risk factors for severity, i.e., age, obesity and comorbidities. Prescription of immunomodulators was protective against severe COVID 19, raising the hypothesis of their potential immunological effect on the immune storm phase of Sars-Cov2.