ABSTRACT
Introduction: The exhaustive registry of COVID-19 cases in patients with IBD is a unique opportunity to learn how to deal with this infection, especially in reference to the management of immunosuppressive treatment, isolation measures or if the disease is more severe in IBD patients due to immunosuppression. Aims & Methods: Aims: The aims of this study were to know the incidence and characteristics of COVID-19 in the ENEIDA cohort during the first wave of the pandemic;the outcomes among those under immunosuppressants/ biologics for IBD;the risk factors for contracting the infection and poor outcomes;and the impact of the infection after three-month followup. Methods: Prospective observational cohort study of all IBD patients with COVID-19 included in the ENEIDA registry (with 60.512 patients in that period) between March and July 2020, with at least 3 months of follow-up. Any patient with a confirmed (by PCR or SARS-CoV-2 serology) or probable (suggestive clinical picture) infection was considered as a case. Results: A total of 482 patients with COVID-19 from 63 centres were included: 247 Crohn's disease, 221 ulcerative colitis and 14 unclassified colitis;median age 52 years (IQR: 42-61), 48% women and 44% 1 comorbidity. Diagnosis was made by PCR: 62% and serology: 35%. The most frequent symptoms: fever (69%), followed by cough (63%) and asthenia (38%). During lockdown 78% followed strict isolation. 35% required hospital admission (ICU: 2.7%) and 12% fulfilled criteria for SIRS upon admission. 18 patients died from COVID-19 (mortality:3.7%). 12% stop IBD medication during COVID-19. At 3 months, taken into account all included cases, 76% were in remission of IBD. Age 50 years (OR 2.09;95% CI:1.27-3.4;p=0.004), 1 comorbidities (OR 2.28;95% CI:1.4-3.6;p=0.001), and systemic steroids <3 months before infection (OR 1.3;95%CI:1-1.6;p= 0.003), were risk factors for hospitalisation due to COVID-19. A Charlson score 2 (OR 5.4;95%CI:1.5-20.1;p=0.01) was associated with ICU admission. Age 60 years (OR 7.1;95%CI:1.8-27.4;p=0.004) and having 2 comorbidities (OR 3.9;95% CI:1.3-11.6;p=0.01) were risk factors for COVID- 19 related death. Conclusion: IBD does not seem to worsen the prognosis of COVID-19, even when immunosuppressants and biological drugs are used. Age and comorbidity are the most important prognostic factors for more severe COVID-19 in IBD patients.
ABSTRACT
Introduction: The information regarding IBD patients with COVID-19 suggests that the factors related to bad outcome are older age and comorbidity whereas immunosuppressants do not have a significant impact worsening the disease evolution. Aims & Methods: Aims: To assess if there are differences in epidemiological, demographical, and clinical characteristics between infected and non-infected IBD patients. Methods: Case-control study in IBD patients with COVID-19 (cases) compared to IBD without COVID-19 (controls) in the period March-July/2020 within the ENEIDA registry (promoted by GETECCU and with more than 60.000 IBD patients included). Cases were matched 1:2 by age (±5y), type of disease (CD/UC), gender, and centre. All controls were selected from only one investigator blind to other clinical characteristics of the patients to avoid selection bias. Results: 482 cases and 964 controls from 63 Spanish centres were included. No differences were found within the basal characteristics including CD location, CD behaviour, extraintestinal manifestations, family history of IBD or smoking habits. Cases had ≥ 1 comorbidities (cases:43%vs. controls: 35%, p=0.01) and occupational risk (cases:27% vs. controls:10.6%, p<0.0001) in a higher proportion. Strict lock-down was the only measure demonstrating protection against COVID-19 (cases:49% vs. controls:70%, p<0.0001). There were no differences in the use of systemic steroids (p=0.19), immunosuppressants (p=0.39) or biologics (p=0.28) between cases and controls. Cases were more often treated with aminosalycilates (42% vs.34%, p=0.003). Having ≥ 1 comorbidities (OR:1.6, 95%CI: 1.2-2.1), occupational risk (OR:1.95, 95%CI:1.39-2.7) and the use of aminosalycilates (OR:1.4, 95%CI: 1-1.8) were risk factors for COVID-19. On the other hand, strict lockdown was a protective factor (OR:0.38, CI:0.29-0.49). Conclusion: Comorbidities and epidemiological risk factors are the most relevant aspects for the risk of COVID-19 in IBD patients. This risk of COVID- 19 seems to be increased by aminosalycilates but not by immunosuppressants or biologics. The attitude regarding treating IBD patients with aminosalicylates during COVID-19 pandemic deserves a deeper analysis. (Table Presented).
ABSTRACT
Introduction: Adalimumab (ADA) intensification is recommended for inadequate or loss of response in inflammatory bowel disease (IBD) patients. A new presentation of ADA 80mg administered every other week (eow) has been approved as an alternative to ADA 40mg every week (ew). Data regarding impact of ADA 80mg eow in clinical practice is still scarce. The aim of this study was to assess long-term durability, safety and cost-effectiveness of treatment with ADA 80mg eow in patients with IBD. Aims & Methods: The aim of this study was to assess long-term durability, safety and cost-effectiveness of treatment with ADA 80mg eow in patients with IBD. A retrospective cohort study in a tertiary hospital that included all IBD patients under intensified maintenance therapy with ADA 80mg eow was performed. Durability was calculated considering the time from the first dose to treatment withdrawn or to the end of follow-up. Biological remission (BR) was defined as CR together with fecal calprotectin (FC) <250 μg/g and C-reactive protein (CRP) <5mg/dl. A descriptive analysis was carried out and the data are presented as percentage, median and interquartile range (IQR). A Kaplan-Meier analysis was used to assess durability, multivariate step-by-step analysis using Cox model to investigate factors potentially associated with treatment withdrawn and Wilcoxon signed rank test to compare differences in FC, RCP and ADA levels before and after intensification. Economic impact of ADA 80 eow was estimated considering current price of both ADA 40mg and ADA 80mg pens at our centre: we estimated the cost of 2 ADA 40mg pens for each ADA 80mg used in our patients Results: Eighty-seven patients (72 CD and 15 CU) were included;median age 50 (IQR 40-60), 58% male;median duration of the disease before ADA of 14 years (IQR 7-22);27% were active smokers. Among CD patients, 47% had ileal disease, 14% colonic and 23% ileocolonic. The inflammatory behavior was the most frequent (53%) and 32% had perianal disease. In UC, 47% had extensive colitis. 61 patients (71%) were bio-naïve and 44 (51%) received immunosuppressants at baseline. At the time of escalation, 57 patients (66%) were symptomatic. After intensification, 75 (86%) patients (CD 61 [85%] and UC 14 [93%]) achieved CR and 69 (79.3%) BR. The changes in the levels of FC (median: 176 vs 70), CRP (median: 3.8 vs 1.7) and ADA (4.17 vs 8.53) were significant (p <0.001). 24 patients (28%) discontinued treatment after a median of 6.5 (IQR 4.5- 10.5) months due to: 11 no clinical response (46%), 5 loss of response (21%), 3 adverse events (12%) (psoriasis), 4 endoscopic progression (17%) and 1 fear of COVID-19 (4%). 63 patients (72%) remained under treatment and in CR (median follow-up 19 months, IQR 13-25) and with a median ADA levels of 10.68 mg/l (IQR 7.67-15). 83 patients (95%) reported being satisfied with the administration of ADA 80 mg eow. Use of ADA 80 eow regimen saved 356100€ in patients who maintained treatment. In the multivariate analysis, being in CR when intensifying reduced the risk of treatment discontinuation by 83% (HR 0.17, 95% CI 0.02-1.26;p = 0.02), having reached BR by 96.8% (HR 0.03, 95% CI 0.01-0.09;p <0.001) and having ADA levels ≥5 mg/l after intensification by 48% (HR 0.52, 95% CI 0.3-0.92;p = 0.02). Conclusion: ADA intensification to 80mg eow in IBD patients is safe, effective and may reduce costs in real life clinical practice. Early intensification, even in CR, may enhance ADA treatment durability.