Screening for variants in TPMT did not reduce the proportions of patients with hematologic ADRs during thiopurine treatment for IBD. However, there was a 10-fold reduction in hematologic ADRs among variant carriers who were identified and received a dose reduction, compared with variant carriers who did not, without differences in treatment efficacy. ClinicalTrials.gov number: NCT00521950.
Background and aims
The COVID-19 risk and disease course in inflammatory bowel disease (IBD) patients remains uncertain. Therefore, we aimed to assess the clinical presentation, disease course and outcomes of COVID-19 in IBD patients. Second, we determined COVID-19 incidences in IBD patients and compared this with the general population.
Methods
We conducted a multicenter, nationwide IBD cohort study in the Netherlands and identified patients with COVID-19. First, we assessed the COVID-19 disease course and outcomes. Second, we compared COVID-19 incidences between our IBD study cohort and the general Dutch population.
Results
We established an IBD cohort of 34,763 patients. COVID-19 was diagnosed in 100/34,763 patients (0.29%). 20/100 patients (20%) had severe COVID-19 defined as admission to the intensive care unit, mechanical ventilation, and/or death. Hospitalization occurred in 59/100 (59.0%) patients and 13/100 (13.0%) died. All patients who deceased had comorbidities and all but one were > 65 years. In line, we identified > 1 comorbidity as an independent risk factor for hospitalization (OR 4.20, 95% CI 1.58-11.17, p = 0.004). Incidences of COVID-19 between the IBD study cohort and the general population were comparable (287.6 (95% CI 236.6-349.7) versus 333.0 (95% CI 329.3-336.7) per 100,000 patients, respectively; p = 0.15).
Conclusions
Of 100 cases with IBD and COVID-19, 20% developed severe COVID-19, 59% was hospitalized and 13% died. A comparable COVID-19 risk was found between the IBD cohort (100/34,763 = 0.29%) and the general Dutch population. The presence of > 1 comorbidities was an independent risk factor for hospitalization due to COVID-19.
Summary
Background
Infliximab biosimilars have become available for treatment of inflammatory bowel disease (IBD). However, data showing long‐term safety and effectiveness of biosimilars in IBD patients are limited.
Aim
To study prospectively the switch from infliximab innovator to biosimilar in an IBD cohort with 12 months follow‐up to evaluate safety and effectiveness.
Methods
Adult IBD patients from two hospitals treated with infliximab innovator (Remicade; Janssen Biotech, Horsham , Pennsylvania, USA) were switched to infliximab biosimilar (Inflectra; Hospira, Lake Forest, Illinois, USA) as part of routine care, but in a controlled setting. Blood samples were taken just before the first, second, fourth and seventh infusion of biosimilar. Infliximab trough levels, antibodies‐to‐infliximab (ATI), CRP and ESR were measured and disease activity scores were calculated.
Results
Our cohort consisted of 133 IBD patients (64% CD, 36% UC). Before switching we found widely varying infliximab levels (median 3.5 μg/mL). ATI were detected in eight patients (6%). Most patients were in remission or had mild disease (CD: 82% UC: 90%). After switching to biosimilar, 35 patients (26%) discontinued therapy within 12 months, mostly due to subjective higher disease activity (9%) and adverse events (AE, 9.8%). AE included general malaise/fatigue (n = 7), arthralgia (n = 2), skin problems (n = 2) and infusion reactions (n = 2). No differences in IFX levels, CRP, and disease activity scores were found between the four time points (P ≥ .0917).
Conclusions
We found no differences in drug levels and disease activity between infliximab innovator and biosimilar in our IBD cohort, indicating that biosimilars are safe and effective. The high proportions of discontinuers were mostly due to elective withdrawal or subjective disease worsening.
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