Real-Life Comparison of Different Anti-TNF Biologic Therapies for Ulcerative Colitis Treatment: A Retrospective Cohort Study

Abstract

Background: Head-to-head comparison studies evaluating the effectiveness and tolerability of anti-tumor necrosis factor (anti-TNF) drugs in inflammatory bowel disease patients are lacking. Aim: To compare the effectiveness and tolerability of anti-TNF-α drugs used in clinical practice in a cohort of patients with moderate-to-severe ulcerative colitis (UC). Methods: Retrospectively, 122 UC patients treated with infliximab (IFX) originator and biosimilar, adalimumab (ADA), and golimumab (GOL) were included. We performed an ITT analysis to evaluate clinical response and remission, steroid-free clinical remission, and endoscopy response according to the different time points of the follow-up. Baseline and post indErledigt ((Please, could you write "post induction" and remove "postinduction"?))uction predictor factors of these outcomes were evaluated using multivariate logistic regression models. Moreover, a propensity score-based weighting analysis was performed. Data were analyzed using R and STATA11 software. Results: The overall clinical response was 77% after induction, 81.4% at 30 weeks, and 76.9% at 52 weeks, while the steroid-free clinical remission was 39.7, 46, and 54.6%, respectively. After induction, a higher rate of treatment failure was observed in the GOL group. At the end of follow-up, lower rates of steroid-free clinical remission and clinical response were obtained by GOL. At week 52, endoscopic response was achieved by 46.5% of the population. Conclusions: Among the different anti-TNF treatments, moderate-to-severe UC seems to respond better to IFX and ADA, whereas GOL seems to be less effective, despite a similar good safety profile.

Adalimumab biosimilars, ABP501 and SB5, are equally effective and safe as adalimumab originator

“…Prognosis dramatically changed after the introduction of biological agents, including anti-Tumor Necrosis Factor-alpha (TNF-α) 6 , which can control flares, prevent complications and halt disease progression 7 , 8 . Among these agents, Adalimumab (ADA) originator, Humira, a fully human IgG1 monoclonal antibody directed against TNF-α, was introduced in 2002 and soon became one of the mainstays of therapy for moderate to severe IBD 7 , 9 – 11 .…”

“…and halt disease progression 7,8 . Among these agents, Adalimumab (ADA) originator, Humira, a fully human IgG1 monoclonal antibody directed against TNF-α, was introduced in 2002 and soon became one of the mainstays of therapy for moderate to severe IBD 7,[9][10][11] .…”

Long-term, Real-life, Observational Study in Treating Outpatient Ulcerative Colitis with Golimumab

“…Why this unfavorable result occurs remains therefore unknown, however, some speculative hypotheses can be made. Firstly, real-life data found that anti-TNF antibodies work less in UC, both originator or biosimilars [21,30,31]; secondly several studies found GOL less effective than adalimumab and infliximab in UC patients [21,29,32]; thirdly, Jung et al [33] found recently that, in UC, GOL initiators had a higher risk of non-persistence and switching than infliximab initiators, in particular when using corticosteroids. This last point could in part explain our results.…”

“…PURSUIT trials found s.c. GOL effective in obtaining and maintaining remission in moderate-to-severe UC [11,12], while no effectiveness was found when the drug was administered by the intravenous route [13]. Several real-life studies have been published on patients with UC treated with golimumab in daily clinical practice [14][15][16][17][18][19][20][21] and have identified some factors possibly associated with a better response rate to GOL, such as a lack of previous exposure to anti-TNF antibodies and short duration of disease. However, these studies had generally a relatively small sample size, thus limiting the generalizability of their results and, more important, demonstrating a limited follow-up.…”

Incidence comparison of adverse events in patients with inflammatory bowel disease receiving different biologic agents: retrospective long-term evaluation

“…In particular, anti-tumor necrosis factor (TNF) therapies such as infliximab, adalimumab (ADA), and golimumab have greatly improved treatment expectations in IBD patients refractory or intolerant to standard treatments, allowing achievement and maintenance of clinical remission and mucosal healing. [5][6][7][8][9][10][11] Moreover, these drugs are able to halt IBD progression, improve the quality of life of the patients and control the disability associated with IBD. 2,[12][13][14][15][16][17]…”