Safety Profile of Anti-TNF Therapy in Crohn’s Disease Management: A Brazilian Single-Center Direct Retrospective Comparison Between Infliximab and Adalimumab

Abstract

BACKGROUND: Infliximab and adalimumab are considered effective drugs in the management of Crohn’s disease. However, due to significant immunossupression, they can cause important adverse events, mostly infections. OBJECTIVE: The aim of this study was to quantify and describe adverse events derived from adalimumab and infliximab use in Crohn’s disease patients, and to compare the safety profile between these two agents. METHODS: This was an observational, single-center, longitudinal, retrospective study with Crohn’s disease patients under infliximab or adalimumab therapy. Variables analyzed: demographic characteristics (including the Montreal classification), type of agent used, concomitant immunomodulators, presence and types of adverse events observed. Patients were allocated in two groups (infliximab and adalimumab) and had their adverse events accessed and subsequently compared. RESULTS: A total of 130 patients were included (68 in infliximab and 62 in adalimumab groups, respectively). The groups were fully homogeneous in all baseline characteristics, with a median follow-up of 47.21±36.52 months in the infliximab group and 47.79±35.09 in the adalimumab group (P=0.512). Adverse events were found in 43/68 (63.2%) and 40/62 (64.5%) in each group, respectively (P=0.879). There were no differences between the groups regarding infections (P=0.094) or treatment interruption (P=0.091). There were higher rates of infusion reactions in the infliximab group (P=0.016). Cephalea and injection site reactions were more prevalent in adalimumab patients. CONCLUSION: Adverse events were found in approximately two thirds of Crohn’s disease patients under anti-TNF therapy, and there were no significant differences between infliximab or adalimumab.

Long‐term outcomes of patients with Crohn's disease who received infliximab or adalimumab as the first‐line biologics

“…The short‐term efficacy, including achievement of steroid‐free remission, and the continuation of the first anti‐TNF agent were similar between the patients treated with IFX first and those treated with ADA first, and these results were consistent with those reported in previous studies . The similarity of our patient characteristics and short‐term outcomes with those in previous studies suggests a high level of confidence in the quality of our long‐term outcome analysis, which is the highlight of the current study.…”

“…No head‐to‐head comparisons have been performed regarding which agent, IFX or ADA, should be administered first for biologic‐naïve CD patients. Therefore, several retrospective and a few prospective studies have compared the rates of clinical or steroid‐free remission, surgery, loss of response (LOR), and adverse events between patients who received IFX first and those who received ADA first . However, most of these previous reports evaluated relatively short‐term outcomes only and discontinued observation of patient clinical courses at the first episode of LOR.…”

“…Therefore, several retrospective and a few prospective studies have compared the rates of clinical or steroid-free remission, surgery, loss of response (LOR), and adverse events between patients who received IFX first and those who received ADA first. [2][3][4][5][6][7][8][9][10][11][12][13][14] However, most of these previous reports evaluated relatively short-term outcomes only and discontinued observation of patient clinical courses at the first episode of LOR. Therefore, long-term outcomes of the patients who were administered each agent as the first-line biologic have scarcely been reported.…”

Anti-TNF Therapy in Crohn’s Disease

“…Long-term therapeutic use of anti-TNF carries with it safety issues which include potential for development of skin lesions, immune reactions, peri-operative complications, infections, cancers and decreased fertility/adverse effects on pregnancy [79,110]. …”

Immune Reconstitution After Autologous Hematopoietic Stem Cell Transplantation in Crohn’s Disease: Current Status and Future Directions. A Review on Behalf of the EBMT Autoimmune Diseases Working Party and the Autologous Stem Cell Transplantation In Refractory CD—Low Intensity Therapy Evaluation Study Investigators

“…Recent single and multicenter cohort studies have reported a significant burden of adverse events with anti-TNF therapies including an increased risk of lymphoma independent of the use of concomitant thiopurine therapy ( 8 , 9 ). The anti-integrin vedolizumab and the IL-12/23 antibody ustekinumab are both licensed as second-line biologic therapy for refractory CD.…”