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Remarkable effects of infliximab on severe radiation-induced side effects in a patient with uterine cervical cancer: a case report.

Pelvic radiotherapy is a powerful treatment for a broad range of cancers, including gynecological, prostate, rectal, and anal cancers. Despi … adiation-induced intestinal side effects was treated with the tumor necrosis factor-alpha inhibitor infliximab with a dose of 3 mg/kg every 4 to 6 weeks. With infliximab treatment, a remarkable improvement in her bowel health was observed. The patient's late bowel toxicity was reduced from Grade 2 to Grade 0 (RTOG/EORTC Late Radiation Morbidity Scale). Altho …

Infliximab decreases inflammatory activity but has no effect on small fiber neuropathy related symptoms in Dutch patients with sarcoidosis.

BACKGROUND AND AIM: Small fiber neuropathy (SFN) may present as complication in sarcoidosis.(1) SFN can potentially result into a large range of symptoms with a high impact on quality of life.(2) Although treatment of the underlying disease of SFN is paramount, little research has been performed to investigate SFN improvement as consequence of sarcoidosis treatment. This retrospective study investigates whether there is an association between the anti-inflammatory effects of infliximab and SFN-symptoms Methods: The Small Fiber Neuropathy Screening List (SFNSL) was used to measure changes in SF…

Comparative safety of infliximab and adalimumab on pregnancy outcomes of women with inflammatory bowel diseases: a systematic review & meta-analysis.

BACKGROUND: Inflammatory bowel disease (IBD) is a condition that affects most of the digestive tract. There is no report of fertility reduction in medically managed IBD women compared with the general population. On the other hand, active IBD can lead to significantly decreased fertility. Over the previous 2 decades, anti-tumor necrosis factor (anti-TNF) has been an effective treatment for managing patients with IBD, increasing the use of infliximab and adalimumab in clinical practice. However, it is unclear which biologics are better for pregnant women with IBD. AIM: We conducted a systemati…

Safety, efficacy, and drug survival of the infliximab biosimilar CT-P13 in post-marketing surveillance of Japanese patients with psoriasis.

Based on extrapolation of similar clinical outcomes in rheumatoid arthritis to the originator infliximab (IFX) in randomized clinical trials, the first biosimilar antibody CT-P13 was approved for the treatment of psoriasis. To evaluate the safety, efficacy, and drug survival of CT-P13 for psoriasis in real-world clinical practice, prospective post-marketing surveillance was conducted in 165 Japanese psoriasis patients. During a 1-year follow-up period, adverse drug reactions (ADRs) occurred in 29 patients (17.6%). Infusion reaction was the most frequent ADR (6.7%), and mild pneumonia was repor…

Combining Nivolumab and Ipilimumab with Infliximab or Certolizumab in Patients with Advanced Melanoma: First Results of a Phase Ib Clinical Trial.

PURPOSE: TNF blockers can be used to manage gastrointestinal inflammatory side effects following nivolumab and/or ipilimumab treatment in patients with advanced melanoma. Our preclinical data showed that anti-TNF could promote the efficacy of immune checkpoint inhibitors. PATIENTS AND METHODS: TICIMEL (NTC03293784) is an open-label, two-arm phase Ib clinical trial. Fourteen patients with advanced and/or metastatic melanoma (stage IIIc/IV) were enrolled. Patients were treated with nivolumab (1 mg/kg) and ipilimumab (3 mg/kg) combined to infliximab (5 mg/kg, N = 6) or certolizumab (400/200 mg, …

Comparative clinical efficacy and safety of the proposed biosimilar ABP 710 with infliximab reference product in patients with rheumatoid arthritis.

BACKGROUND: ABP 710 is being developed as a biosimilar to infliximab reference product (RP). Analytical similarity and pharmacokinetic equivalence between the two have been previously demonstrated. Here we report results from a comparative clinical study that evaluated the efficacy and safety of ABP 710 relative to the RP in patients with rheumatoid arthritis (RA). METHODS: In this multicenter, randomized, double-blind, 50-week equivalence study, patients with moderate to severe active RA despite methotrexate received 3-mg/kg infusions of ABP 710 or RP at predetermined intervals based on init…

The potential of circulating microRNA-125a and microRNA-125b as markers for inflammation and clinical response to infliximab in rheumatoid arthritis patients.

OBJECTIVE: This study was to investigate the changes in circulating microRNA (miR)-125a and miR-125b during infliximab (IFX) treatment, and their value in predicting clinical response to IFX in rheumatoid arthritis (RA) patients. METHODS: The plasma samples were obtained from 96 active RA patients who underwent 24-week IFX treatment and from 96 healthy controls to detect miR-125a and miR-125b expressions by RT-qPCR. Clinical response was assessed according to EULAR criteria based on disease activity alleviation at week 4, week 12, and week 24. RESULTS: MiR-125a and miR-125b expressions were …

Infliximab induces clinical resolution of sacroiliitis that coincides with increased circulating FOXP3+ T cells in a patient with IPEX syndrome.

Immune dysregulation, polyendocrinopathy, enteropathy, X-linked (IPEX) syndrome is a rare monogenic primary immunodeficiency due to mutation … eveloped severe exacerbation of inflammatory low back pain in relation to sacroiliitis. Eventually, infliximab was initiated to control his back pain with rapid resolution as well as digestive improvement and also reduced biological inflammatory markers. In parallel, flow cytometry analysis revealed an increase in the frequency of circulating FOXP3+ CD4+ Tre …

Infliximab biosimilar for treating neurosarcoidosis: tolerance and efficacy in a retrospective study including switch from the originator and initiation of treatment.

OBJECTIVES: Infliximab is increasingly used to treat neurosarcoidosis. We aimed to determine the efficacy and tolerance of an infliximab biosimilar for treating neurosarcoidosis. METHODS: We conducted a retrospective single-center study to describe the efficacy, safety and immunogenicity of an infliximab biosimilar in neurosarcoidosis patients. We compared the survival time without relapse while receiving the biosimilar or previous originator-infliximab treatment. RESULTS: Twenty patients with histologically documented neurosarcoidosis were treated with an infliximab biosimilar (initiation o…

Diffuse large B-cell lymphoma of the colon and rectum in a patient with colonic Crohn's disease treated with infliximab and azathioprine.

A 52-year-old woman was treated for colorectal diffuse large B-cell lymphoma (DLBCL) after a prolonged treatment period of azathioprine (AZA) and infliximab (IFX) for Crohn's disease (CD). She had been diagnosed as having colonic CD at the age of 24 years and received AZA from age 29. IFX was added at 47 years of age. She experienced massive hematochezia and anal pain at the age of 52 years and was transferred to our hospital. Endoscopic examination revealed a deep rectal ulcer with arterial bleeding. A stoma constructed at the transverse colon for refractory CD relieved her symptoms. Four mon…

Efficacy of Adjunctive Infliximab vs Placebo in the Treatment of Adults With Bipolar I/II Depression: A Randomized Clinical Trial.

IMPORTANCE: To our knowledge, no study has previously evaluated whether individuals with bipolar depression enriched a priori on the basis of biochemical and/or phenotypic immuno-inflammatory activation would differentially respond to an anti-inflammatory agent for the treatment of depressive symptoms. OBJECTIVE: To assess the antidepressant efficacy of adjunctive infliximab, a monoclonal antibody targeting tumor necrosis factor, in adults with bipolar I and bipolar II depression and inflammatory conditions. DESIGN, SETTING, AND PARTICIPANTS: This 12-week, randomized, double-blind, placebo-c…

Infliximab abrogates cadmium-induced testicular damage and spermiotoxicity via enhancement of steroidogenesis and suppression of inflammation and apoptosis mediators.

Cadmium(Cd) is a serious environmental and occupational contaminant that represents a serious health hazard to humans and other animals. Reproductive health problems have been reported in men exposed to Cd. Testicular damage is one of the deleterious effects due to Cd exposure. Cd-induced testicular toxicity is mediated through oxidative stress, inflammation, testosterone inhibition and apoptosis. Thus, the present study was performed to assess the possible protective role of infliximab (IFX), anti-TNFα agent, against Cd-induced testicular damage and spermiotoxicity in rats. The rats were rand…

Clinical and quality of life improvements with golimumab or infliximab in a real-life ankylosing spondylitis population: the QUO-VADIS study.

OBJECTIVES: The QUO VADIS study evaluated disease activity and health-related quality-of-life (HRQoL) in ankylosing spondylitis (AS) patients treated with golimumab (GLM) or infliximab (IFX, originator) during routine clinical care. METHODS: This prospective observational study followed biologics-naïve AS patients newly treated with GLM or IFX for 6 months. Disease activity (BASDAI, BASFI, ASAS, and ASDAS) and HRQoL improvement (≥5 points of SF-36 Physical Component Summary [PCS] score; PCS response) were measured. A Classification and Regression Trees (CART) analysis evaluated association of…

The Effectiveness of Pre- and Postoperative Infliximab in Controlling Behçet's Disease Posterior Uveitis in Patients Undergoing Vitrectomy: A Preliminary Study.

Purpose. To evaluate the short-term effectiveness of infliximab in controlling ocular manifestations in Behçet's Disease (BD) patients candidate for pars plana vitrectomy, if given in a regimen before and after the planned procedure. Patients and Methods. 30 eyes of 27 adult male BD patients with a mean age of 35.56 yrs presented with refractory posterior uveitis not responding to immunosuppressive drugs and candidate for vitrectomy were included. Infliximab was given in a dose of 5 mg/kg intravenous infusion once every two weeks for 3 treatment sessions before the intended vitrectomy followed…

Improving a process to obtain hepatitis B serology among patients treated with infliximab at a large urban children's hospital.

BACKGROUND: Hepatitis B infection is a significant public health challenge despite improvements in vaccination efforts. Patients such as those on chronic immunosuppressive therapy for inflammatory bowel disease (IBD) or rheumatic disease may incur greater risk. The risk of reactivation of hepatitis B while on immunosuppressive therapy may have mortality rates up to 25%. These patients should be screened for acute or chronic infection and vaccinated if necessary. Our aim was to reliably complete hepatitis B screenings in patients receiving infliximab at Cincinnati Children's Hospital Medical Ce…

Efficacy of Switching from Infliximab to Subcutaneous Golimumab in Patients with Rheumatoid Arthritis to Control Disease Activity or Adverse Events.

BACKGROUND: Some rheumatoid arthritis (RA) patients initially respond to treatment with infliximab (IFX), but subsequently their responsiveness decreases. OBJECTIVES: Our objective was to evaluate the efficacy and safety of switching from IFX to subcutaneous golimumab (GLM-SC) in RA patients. METHODS: Thirty-three patients who had been treated for a mean 4.4 years with IFX (3-6 mg/kg/8 weeks) were switched to GLM-SC to control disease activity or adverse events. The patients with low disease activity (LDA) or remission were divided into two groups: the LDA group and the LDA every 8 weeks (q8…

Вирусная инфекция оккультного гепатита В развилась у пациента с псориатическим артритом под инфиксимабом и метотрексатом.

Несмотря на отсутствие международных руководящих принципов в отношении лечения пациентов, инфицированных оккультным гепатитом В (ОБИ), начинающих блокировать TNF-α, есть некоторые свидетельства реальной жизни, что эти лекарства безопасны у пациентов ОБИ с ревматическими заболеваниями. Напротив, управление так называемыми ложными пациентами УБН все еще не определено. Мы описываем случай острого гепатита В (ГБВ) инфекции, имевшего место в случае антиГБ и ВИЧ-положительного пациента, затронутого псориатическим артритом, который в течение пяти лет лечился инфликсимабом. Базовый анализ HBV-DNA не п

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Despite lacking of international guidelines about the management of patients with occult hepatitis B virus infection (OBI) starting TNF-α bl … nti- HBc positive patient affected by psoriatic arthritis, who had been treated for five years with infliximab. Baseline HBV-DNA analysis had not been performed. Although HBs Ag was still negative and the transaminases in the normal range, HBV-DNA serum analysis surprisingly showed high replication rate. Entecavir was added, and three months later HBV-DNA wa …