Biological therapy for inflammatory bowel disease: cyclical rather than lifelong treatment?

Inflammatory bowel disease (IBD) treatment was revolutionised with the arrival of biological therapy two decades ago. There are now multiple biologics and increasingly novel small molecules licensed for the treatment of IBD. Treatment guidelines highlight the need for effective control of inflammation and early escalation to advanced therapies to avoid long-term complications. Consequently, a large proportion of patients with IBD receive advanced therapies for a long time. Despite their beneficial risk-benefit profile, these treatments are not without risk of side effects, are costly to healthcare providers and pose a burden to the patient. It is, therefore, paramount to examine in which circumstances a temporary cessation of therapy can be attempted without undue clinical risk. Some patients may benefit from cyclical rather than continuous treatment. This review examines the risk of relapse after discontinuation of advanced therapies, how to identify patients at the lowest risk of relapse and the chance of recapturing response when flaring after discontinuation.

Impact on direct and indirect costs of switching patients with inflammatory bowel disease from intravenous to subcutaneous infliximab (CT-P13).

BACKGROUND: We aim to compare the real-life direct and indirect costs of switching patients from intravenous to subcutaneous (SC) CT-P13, an infliximab biosimilar, in a tertiary UK Inflammatory Bowel Disease (IBD) centre. METHODS: All adult patients with IBD on standard dosing CT-P13 (5 mg/kg 8 weekly) were eligible to switch. Of 169 patients eligible to switch to SC CT-P13, 98 (58%) switched within 3 months and one moved out of area. RESULTS: Total annual intravenous cost for 168 patients was £689 507.04 (direct=£653 671.20, indirect=£35 835.84). After the switch, as-treated analysis demonstrated total annual cost for 168 patients (70 intravenous and 98 SC) was £674 922.83 (direct = £654 563, indirect = £20 359.83) resulting in £891.80 higher cost to healthcare providers. Intention to treat analysis showed a total annual cost of £665 961.01 (direct = £655 200, indirect = £10 761.01) resulting in £1528.80 higher cost to healthcare providers. However, in each scenario, the significant decrease in indirect costs resulted in lower total costs after switching to SC CT-P13. CONCLUSIONS: Our real-world analysis demonstrates switching from intravenous to SC CT-P13 is broadly cost neutral to healthcare providers. SC preparations have marginally higher direct costs, switching allows for efficient use of intravenous infusion units and reduces costs to patients.

Impact of the coronavirus infectious disease (COVID-19) pandemic on the provision of inflammatory bowel disease (IBD) antenatal care and outcomes of pregnancies in women with IBD.

BACKGROUND: The impact of COVID-19 on pregnant inflammatory bowel disease (IBD) patients is currently unknown. Reconfiguration of services during the pandemic may negatively affect medical and obstetric care. We aimed to examine the impacts on IBD antenatal care and pregnancy outcomes. METHODS: Retrospective data were recorded in consecutive patients attending for IBD antenatal care including outpatient appointments, infusion unit visits and advice line encounters. RESULTS: We included 244 pregnant women with IBD, of which 75 (30.7%) were on biologics in whom the treatment was stopped in 29.3% at a median 28 weeks gestation. In addition, 9% of patients were on corticosteroids and 21.5% continued on thiopurines. The care provided during 460 patient encounters was not affected by the pandemic in 94.1% but 68.2% were performed via telephone (compared with 3% prepandemic practice; p<0.0001). One-hundred-ten women delivered 111 alive babies (mean 38.2 weeks gestation, mean birth weight 3324 g) with 12 (11.0%) giving birth before week 37. Birth occurred by vaginal delivery in 72 (56.4%) and by caesarean section in 48 (43.6%) cases. Thirty-three were elective (12 for IBD indications) and 15 emergency caesarean sections. Breast feeding rates were low (38.6%). Among 244 pregnant women with IBD, 1 suspected COVID-19 infection was recorded. CONCLUSION: IBD antenatal care adjustments during the COVID-19 pandemic have not negatively affected patient care. Despite high levels of immunosuppression, only a single COVID-19 infection occurred. Adverse pregnancy outcomes were infrequent.

Acute severe ulcerative colitis: management advice for internal medicine and emergency physicians.

Acute severe ulcerative colitis is a medical emergency that warrants in-patient management. This is best served within a multidisciplinary team setting in specialised centres or with expert consultation. Intravenous corticosteroids remain the cornerstone in the management of ASUC and should be initiated promptly, along with general management measures and close monitoring of patients. Unfortunately, one-third of patients will fail to respond to steroids. Response to intravenous corticosteroid therapy needs to be assessed on the third day and rescue therapies, including cyclosporine and infliximab, should be offered to patients not responding. Choice of rescue therapy depends on experience, drug availability and factors associated with each individual patient, such as comorbidities, previous medications or contra-indications to therapy. Patients who have not responded within 7 days to rescue therapy must be considered for surgery. Surgery is a treatment option in ASUC and should not be delayed in cases of failure of medical therapy, because such delays increase surgical morbidity and mortality. This review summarises the current management of acute severe ulcerative colitis and discusses potential future developments.

Current smoking habits in British IBD patients in the age of e-cigarettes.

BACKGROUND: Smoking has a detrimental effect on Crohn's disease (CD) while data on ulcerative colitis (UC) are conflicting. Smoking habits have changed dramatically in the UK due to a public smoking ban and the advent of e-cigarettes. We describe current smoking rates in patients with inflammatory bowel disease (IBD) and any effects on disease course. METHODS: Self-reported smoking status was elicited in outpatients with IBD, and clinical data were extracted from patient records. RESULTS: Of 465 patients (58% CD, 42% UC), 247 (53.1%) were ever-smokers (37.4% ex-smokers, 15.7% current smokers). Electronic cigarettes (e-cigarettes) were ever used by 28 patients (15 current users). All e-cigarette users had previously smoked cigarettes and 13 had stopped smoking completely. Patients with CD were more likely to currently smoke (21.5% vs 7.7%, p<0.001) than those with UC. Ever use of biological therapy was higher in current smokers compared with never smokers (49% vs 35%, p=0.034). The need for surgery was higher in current smokers compared with never smokers (43% vs 25%, p=0.006). The risk of CD complications during 21-month prospective follow-up was numerically higher for current smoker versus e-cigarette users (53% vs 17%, p=0.19).Compared with the general population, the proportion of current cigarette smokers (14.9% vs 15.1%) and e-cigarette users was similar in our cohort (4.26% vs 5.5%). CONCLUSIONS: Patients with IBD show similar smoking behaviour to the general population. E-cigarettes were used as replacement for cigarettes or by some as an intermediate step for smoking cessation. Larger, prospective studies are required to fully determine the effects of e-cigarettes on IBD.