Long-term clinical and real-world experience with Crohn’s disease treated with anti-tumor necrosis factor-α antibodies

Abstract

Background/Aims: Although anti-tumor necrosis factor (TNF)-α agents are important therapeutic drugs for Crohn’s disease (CD), data regarding their long-term sustained effects are limited. Herein, we evaluated the long-term loss of response (LOR) to anti-TNF-α agents in patients with CD.Methods: This retrospective study included patients with CD who started treatment with infliximab or adalimumab as a first-line therapeutic approach. The cumulative event-free, retention, and surgery-free rates after the start of biological therapy were analyzed. Secondary LOR was analyzed in patients who achieved corticosteroid-free clinical remission after the start of biological therapy. Cox proportional hazards models were used to analyze the predictive factors of secondary LOR.Results: The cumulative event-free rates at 1, 2, 5, and 10 years were 83.3%, 75.1%, 37.4%, and 23.3%, respectively. The incidence of LOR was 10.6% per patient-year of follow-up. At 12–14 weeks after the start of biological therapy, the proportion of patients with a C-reactive protein to albumin (CRP/ALB) ratio ≥0.18 was significantly higher in patients with LOR (<i>P</i><0.001). Multivariate analysis indicates that a CRP/ALB ratio ≥0.18 (hazard ratio [HR], 5.86; 95% confidence interval [CI], 1.56–22.0; <i>P</i>=0.009) and upper gastrointestinal tract inflammation (HR, 3.00; 95% CI, 1.26–7.13; <i>P</i>=0.013) were predictive factors of secondary LOR.Conclusions: Although anti-TNF-α agents contributed to long-term clinical remission of CD, the annual incidence of secondary LOR was 10.6%. The CRP/ALB ratio at 3 months after the start of biological therapy and upper gastrointestinal tract inflammation were identified as predictive factors of secondary LOR.

Impact of age at diagnosis on long‐term prognosis in patients with intestinal Behçet's disease

“…While treatment strategies for intestinal BD are, in large part, dependent on the physician's discretion, 5 general treatment has been performed in a manner similar to CD, namely, step-up therapy according to disease severity. 2,31,32 Immunosuppressants, including thiopurines, methotrexate, and tacrolimus, are indicated for patients with moderate-to-severe disease activity or corticosteroid dependency. 5,33,34 In our study, more patients in the early-onset group required immunosuppressants than in the adult-onset and late-onset groups.…”

“…24 Clinical disease activity was assessed according to the DAIBD, which consists of eight items: general well-being, fever, EIM, abdominal pain, abdominal mass, abdominal tenderness, intestinal complications, and number of liquid stools, with scores ranging from 0 to 325. Based on calculated DAIBD score, disease severity was classified into four disease groups: quiescent (≤ 19); mild (20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30)(31)(32)(33)(34)(35)(36)(37)(38)(39); moderate ; and severe (≥ 75). 25 Typical ulcers were defined as large, oval-shaped, and deep-penetrating ulcers with discrete borders in the ileocecal area.…”

Usefulness of Serum Leucine-rich Alpha 2 Glycoprotein in Crohn’s Disease: Is There Any Difference between Small Intestine and Colonic Lesions?

“… 19 We previously reported that CRP level at the introduction of anti-TNFα agents is a predictor of reduced therapeutic effects in patients with CD, 26 and that CRP/Alb ratio at 3 months after the introduction of anti-TNFα agents is a predictor of secondary failure. 27 A previous report on patients with CD who started treatment with anti-TNFα agents showed that treat-to-target strategies based on CRP or Alb were useful for preventing hospitalization, surgery, and discontinuation of biological therapy for CD. 28 Thus, a combination of CRP and Alb, which are simple biomarkers, can improve the ability to predict mucosal healing.…”

Effectiveness of Switching to Subcutaneous Infliximab in Ulcerative Colitis Patients Experiencing Intravenous Infliximab Failure

“… 11 - 13 However, a significant proportion of IBD patients treated with intravenous (IV) infliximab experience nonresponse or loss of response (LOR), thus necessitating either a dose escalation of IV infliximab or switching to another biologic/small molecule agent. 14 - 16 Unfortunately, in several countries, including South Korea, the healthcare system or insurance programs do not permit the dose escalation of IV infliximab in such cases (e.g., up to 10 mg/kg every 8 weeks or 5 mg/kg every 4 weeks). Recently, a new subcutaneous (SC) formulation of infliximab, namely, CT-P13 SC, has been developed, 17 and it has shown comparable efficacy and safety with improved acceptability.…”