ABSTRACT
Background: Recently, a subcutaneous formulation of biosimilar infliximab (CT-P13) (SC-IFX) has been approved for inflammatory bowel disease (IBD). The aims of this study were to evaluate efficacy, safety, pharmacokinetics and patient experience following a switching to SC-IFX in patients who are in clinical remission on IV-IFX maintenance treatment. Method(s): Multicentre, descriptive, and observational study including Crohn's disease (CD) and ulcerative colitis (UC) patients who were going to be changed from IV-IFX to SC-IFX on the ENEIDA registry (a large, prospectively maintained database of the Spanish Working Group in IBD-GETECCU). All patients were on clinical and biological remission at least 24 weeks before changing. Demographic and disease data, clinical activity (Harvey-Bradshaw index for CD and mayo index for UC), analytical data (C reactive protein (CRP) and fecal calprotectin (FC), as well as trough levels were collected at baseline, at 12 and 24 weeks. Result(s): One hundred and fifty-five patients were included: 54 UC (35%) and 91 (65%) CD;44% women and 56% men;age 45.5 years (32-55). IV-IFX was mainly administered due to active disease (72%) and perianal disease (7%) and during 32 months [range 14-56]. Preswitch, 78 (50.3%) were on 8-weekly dosing of IV-IFX, 77 (49.7%) were with intensification dose and the half (50.3%) were on concomitant immunomodulatory therapy. SC-IFX was mainly switching by COVID-19 pandemic (60%), to increase through levels (15%) or patient request (25%). The majority of patients (140, 90%) remained with standard dose, 8 (5%) required dose intensification (120 mg weekly in 4 and 240 mg every 2 weeks in 4) and 7 (4.5%) had successful de-escalation (120 mg every 3 weeks in 4 and 120 mg every 4 weeks in 3). Clinical indices, CRP levels and FC remained unchanged (Figure). Median SC-IFX levels significantly increased from baseline of 4.5 mug/ dl [range 2.6-9.2] to 14 mug/dl [range 9.5-16.2] at week 12 and 13.2 mug/ dl [range 10.4-19.7] at week 24. No factors (immunossupresor, body mass index, disease location) were associated with the increase of IFX trough levels. During 24 weeks of follow-up, 16 of the 78 patients (20.5%) stopped immunosuppressant treatment. The adverse events were recorded in 9 patients (5.8%), 4 (2.6%) were hospitalized and 4 (2.6%) had surgery (one of them for perianal disease). Nine patients (5.8%) stopped SC-IFX (1 primary failure, 2 loss of response, 4 adverse events, 1 voluntarily, and 1 surgery). Conclusion(s): The switch from IV to SC IFX maintains clinical remission safely in IBD patients, offers higher drug levels and a good patient acceptance. However, the significance of higher drug levels with SC-IFX requires further exploration.
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: Patients with Irritable bowel syndrome (IBS) have been reported to have higher anxiety and depression levels than general population, as well as dysfunctional coping skills. The total/ partial lockdown due to COVID19 pandemic has been related with an increased incidence of psychological disorders in general population;however, its effect on IBS patients and patients with other chronic GI-conditions like ulcerative colitis (UC) is not known. Aims & Methods: The main goal of this study was to compare the lockdown effect on mental health and digestive symptoms in patients with IBS, UC and healthy volunteers. During April 2020 (Spanish total lockdown), 30 IBS, 30 UC in remission and 30 healthy volunteers were invited to answer an online survey evaluating stress and anxiety levels by the STAI questionnaire and depression using the Beck questionnaire. IBS patients' symptoms were evaluated with IBS-SSS. After 6 months, in October 2020 (partial lockdown in Spain), the same subjects were contacted, and they were asked to answer again the same online questionnaires. Results: Responses were obtained from 24 IBS (67% women, aged 21-67 years), 23 UC (56% women, aged 35-55 years) and 18 healthy volunteers (68% women, aged 23-70 years). During total lockdown, IBS patients presented higher depression index (11.52±1.6) than UC patients (5.78±0.9 (p=0.008)) and healthy volunteers (4.78±4.3 (p=0.001)). IBS patients also had higher anxiety index (state 29.4±2.5 / trait 26.5±2.5) than healthy volunteers (state 15.6±2.3 (p=0.001) / trait 14.4±1.9 (p=0.002)). After 6 months (during partial lockdown) depression levels increased significatively in IBS patients (from 11.52±1.6 to 16.08±2.22 (p=0.012)), but remained unchanged in healthy subjects and UC patients (from 4.78±4.3 to 3.28±0.6 and from 5.78±0.9 to 5.91±1.17 respectively;p< 0.001 vs IBS). Anxiety scores (both state and trait) remained stable during the partial lockdown (6 months after the total lockdown) in the 3 study groups. The severity of digestive symptoms remained unchanged in IBS patients (scores 283±80 and 285±84, total and partial lockdown, respectively;p=0.837). Conclusion: During the lockdown due to COVID-19 pandemic, IBS patients presented higher depression and anxiety levels than healthy volunteers and patients with UC in remission. Additionally, the depression index worsened in IBS patients during the pandemic, while it remained stable in healthy volunteers and UC patients. During this first phase of the pandemic, the observed changes in psychological traits did not impact on abdominal symptoms, but carefully monitoring of IBS patients in the next months seems to be crucial to evaluate the potential repercussion of worsened mental health due to COVID-19 pandemic in IBS.