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Clinical Implementation of Biologics and Small Molecules in the Treatment of Hidradenitis Suppurativa.

Hidradenitis suppurativa (HS) is a chronic, recurrent, auto-inflammatory skin disease originating from the hair follicles. The typical inflammatory nodules, abscesses, and draining sinus tracts (tunnels) are characterized by a massive influx of neutrophils, macrophages, B-cells, plasma cells, T helper (Th)1, Th17 cells and upregulation of pro-inflammatory cytokines such as IL-1, IL-17, IL-12/23, and TNF-α. Over the last decades, several clinical trials evaluated the clinical efficacy of different biologics targeting these pro-inflammatory cytokines, in particular TNF-α and IL-1. However, adali

Health outcomes of 1000 children born to mothers with inflammatory bowel disease in their first 5 years of life.

OBJECTIVE: The aim of this study was to describe the long-term health outcomes of children born to mothers with inflammatory bowel disease (IBD) and to assess the impact of maternal IBD medication use on these outcomes. DESIGN: We performed a multicentre retrospective study in The Netherlands. Women with IBD who gave birth between 1999 and 2018 were enrolled from 20 participating hospitals. Information regarding disease characteristics, medication use, lifestyle, pregnancy outcomes and long-term health outcomes of children was retrieved from mothers and medical charts. After consent of both p

Clinical course and outcomes of diagnosing Inflammatory Bowel Disease in children 10 years and under: retrospective cohort study from two tertiary centres in the United Kingdom and in Italy.

BACKGROUND: Most children with Inflammatory Bowel Disease (IBD) are diagnosed between 11 and 16 years of age, commonly presenting with features of typical IBD. Children with onset of gut inflammation under 5 years of age often have a different underlying pathophysiology, one that is genetically and phenotypically distinct from other children with IBD. We therefore set out to assess whether children diagnosed after the age of 5 years, but before the age of 11, have a different clinical presentation and outcome when compared to those presenting later. METHODS: Retrospective cohort study conduct

Lipid profile of rheumatoid arthritis patients treated with anti-tumor necrosis factor-alpha drugs changes according to disease activity and predicts clinical response.

Patients with active rheumatoid arthritis (RA) frequently show an atherogenic lipid profile, which has been linked with the inflammatory reaction. Inflammatory cytokines, and particularly tumor necrosis factor-alpha (TNF-α), are implicated in the pathogenesis of both atherosclerosis and RA, and also involved in the development of the impaired lipid profile detected in active RA. Although anti-TNF-α agents have been proven effective in controlling joint damage and systemic inflammation, controversy remains about the effect of these drugs on the lipid profile; therefore, the aim of our study was

Biologic treatment or immunomodulation is not associated with postoperative anastomotic complications in abdominal surgery for Crohn's disease.

OBJECTIVES: There are concerns that biologic treatments or immunomodulation may negatively influence anastomotic healing. This study investigates the relationship between these treatments and anastomotic complications after surgery for Crohn's disease. PATIENTS AND METHODS: Retrospective study on 417 operations for Crohn's disease performed at four Danish hospitals in 2000-2007. Thirty-two patients were preoperatively treated with biologics and 166 were on immunomodulation. In total, 154 were treated with corticosteroids of which 66 had prednisolone 20 mg or more. RESULTS: Anastomotic compli

Immunotherapies in rheumatologic disorders.

Over the past several decades, rheumatology has directed its focus to understanding and countering the immune dysregulation underlying autoimmune diseases with rheumatologic manifestations. Older therapies, effective though poorly understood, are being scrutinized anew and are yielding the immune-modulating mechanisms behind their efficacy. New therapies, the "biologics," are drugs tailored to address specific immune defects and imbalances. This article discusses the current standard and biologic immunotherapies of the rheumatic diseases, correlating our current understanding of their mechanis

[Rheumatoid arthritis: current status of therapy].

Rheumatoid Arthritis (RA) is a frequent chronic inflammatory disease characterized by distal, bilateral and symmetrical lesions, leading to joint distortions and articular destructions. RA can also cause severe extra-articular manifestations associated with a poor prognosis. Recent advances in the field of immunopathology of RA have oriented treatment targeting the pro-inflammatory cytokines like tumor necrosis factor-alpha (TNF alpha), interleukin (IL) and IL6. These biotherapies are considered as an important therapeutic progress in the treatment of RA acting at the level of cellular process

[Increased risk of infection with biological immunomodifying antirheumatic agents. Clear guidelines are necessary as shown by case reports].

Several potent immunosuppressive drugs have become available in the new millennium for patients with rheumatologic diseases, Crohn's disease and other autoimmune disorders. Five patient cases from Växjö central hospital (uptake area 178 000 individuals) with Listeria meningitis, Pneumocystis jiroveci and tuberculosis pneumonia, Listeria sepsis, Legionella pneumonia and E coli sepsis are described. A doubled risk for infections has previously been observed for RA patients, as compared to healthy individuals. There is clearly an increased risk of tuberculosis (depending on the actual and histori

Patient Characteristics, Health Care Resource Utilization, and Costs Associated with Treatment-Regimen Failure with Biologics in the Treatment of Psoriasis.

BACKGROUND: Psoriasis is a chronic, incurable, and immune-mediated skin disorder that is characterized by erythematous scaly papules and pla … ly initiated biologic agent for the treatment of psoriasis (etanercept, adalimumab, ustekinumab, or infliximab) between January 2010 and December 2011. The analysis included psoriasis patients aged ≥ 18 years with ≥ 1 prescription claim for a biologic and continuous enrollment 12 months pre- and post-index date. Patients with claims for a biologic in the pre …

A comprehensive review and update on Crohn's disease.

The term inflammatory bowel disease (IBD) refers principally to two major categories of chronic relapsing inflammatory intestinal disorders: … acid products, immunomodulators (Azathioprine, 6-mercaptopurine, methotrexate) and TNF inhibitors (infliximab, adalimumab, certolizumab and golimumab). Surgical interventions like bowel resection, stricturoplasty or drainage of abscess is required in up to two thirds of CD patients during their lifetime. The most common indications for surgical resection ar …

Biologic interventions for fatigue in rheumatoid arthritis.

BackgroundFatigue is a common and potentially distressing symptom for patients with rheumatoid arthritis (RA), with no accepted evidence-bas … our necrosis factor (anti-TNF) biologic agents (adalimumab, certolizumab, etanercept, golimumab and infliximab), and 12 studies focused on five non-anti-TNF biologic agents (abatacept, canakinumab, rituximab, tocilizumab and an anti-interferon gamma monoclonal antibody). All but two of the studies were double-blind randomised placebo-controlled trials. In so …

Special Article: 2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis.

OBJECTIVE: To develop an evidence-based guideline for the pharmacologic and nonpharmacologic treatment of psoriatic arthritis (PsA), as a collaboration between the American College of Rheumatology (ACR) and the National Psoriasis Foundation (NPF). METHODS: We identified critical outcomes in PsA and clinically relevant PICO (population/intervention/comparator/outcomes) questions. A Literature Review Team performed a systematic literature review to summarize evidence supporting the benefits and harms of available pharmacologic and nonpharmacologic therapies for PsA. GRADE (Grading of Recommenda

Persistence of Staphylococcus aureus colonization among individuals with immune-mediated inflammatory diseases treated with TNF-α inhibitor therapy.

OBJECTIVE: We investigated the relationship between Staphylococcus aureus colonization and the use of immunosuppressive therapies in patients with immune-mediated inflammatory diseases (IMIDs). METHODS: We prospectively enrolled IMID patients from the rheumatology and dermatology departments of Oregon Health & Science University. At enrolment, we surveyed patients for S. aureus infection risk factors and those using immune-modulating therapies, and evaluated their colonization status with bilateral nares and inguinal fold cultures. Patients were asked to follow up 6-12 months later for reasse

The Impact of Monoclonal Antibody Usage on Hearing Outcomes: A Systematic Review.

ObjectiveTo ascertain trends in ototoxicity observed with monoclonal antibodies (mABs) and understand the impact they may have on hearing function.Data sourcesPubMed, Embase, Scopus.Review methodsA systematic review was performed following PRISMA guidelines. Data were reviewed for demographics, utilized mABs with respective indication and dosing, audiometric outcomes, and treatment for otologic effects.ResultsOf 757 studies reviewed, a total of 44 were included, encompassing 18,046 patients treated with mABs. Mean age of the sample was 57.8 years old. The search yielded 18 agents of ototoxicit

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… Study | Agent | Evidence Provided | Data Barbieri | Rituximab, Infliximab, Adalimumab, Abatacept | Patient report only | Hypoacusis (rituximab—4/5 ototoxic ADRs), tinnitus (adalimumab—3/4 ototoxic ADRs), unspecified ototoxic ADRs (infliximab— n = 4) Rituximab (5/2041), Infliximab (4/2243), Adalimumab … Touma | Infliximab | Description of audiometric test results only | Case 1 (3 weeks post Cogan's diagnosis): Post infliximab, decrease in the sensation of aural fullness and vertigo and subjective improvement in hearing, associated with improvement on the audiogram in the left ear. …

[Current status of treatment of inflammatory bowel disease].

Inflammatory bowel disease encompasses a group of diseases with poorly defined etiology that affect the digestive tract. These diseases are characterized by their chronic course and by periods of disease activity, of variable severity, that alternate with periods of clinical remission. In the last few years, inflammatory bowel disease has been the object of intense research, which has increased knowledge of the physiopathogenic mechanisms involved. This has enabled the development of a new generation of biotechnological drugs effective in patients previously considered to be refractory to medi

[Tuberculosis during treatment by TNFalpha-inhibitors].

The clinical forms of tuberculosis that occur during anti-TNFalpha treatment are frequently extrapulmonary or even disseminated and life-threatening. The paradoxical reactions that can occur under appropriate treatment after stopping TNFalpha inhibitors raise the question of an immune restoration phenomenon. Adverse drug reaction reporting and epidemiologic studies, despite their methodological limitations, appear to show an excess risk of tuberculosis. Experimental studies reinforce these data. The French drug agency (Afssaps) has issued guidelines for the prevention and management of tubercu

[Pharmacological treatment of COPD and future of anti-inflammatory therapy].

Chronic obstructive pulmonary disease (COPD) is characterized by airflow limitation that is not fully reversible. It is caused by chronic inflammation of the airways and the lung parenchyma. Symptomatic treatment is based on bronchodilatation, which leads to a reduction of hyperinflation and relief of dyspnea. Smoking cessation is the only known causative treatment option. Inhaled corticosteroids (ICS) reduce exacerbations and, potentially, mortality. Future therapies should ameliorate chronic inflammation and thus stop the annual decline of lung function. In face of increasing mortality and m

Сыворотка иммуноактивности к нейрофильтрации показывает высокую чувствительность и специфичность у пациентов с болезнью Бехчета.

БОДЖЕКЦЫ: Болезнь Бехчета (БД) является сложным васкулитом с аутоиммунным и ауто-воспалительным характеристиками. Несмотря на конкретные клинические особенности, не существует лабораторных тестов для диагностики БД. Недавно мы обнаружили, что BD sera демонстрировала иммуноактивность против нейрофильтрованного среднего белка (NF-M). Цель этого исследования состояла в том, чтобы воспроизвести этот вывод в независимой когорте и оценить специфичность и чувствительность NF-иммуноактивности в образцах сыворотки, полученных от пациентов БД, пациентов с систематическими волчанками (SLE), множественных

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… Colchicine, infliximab BD6 F + +/+ + + + + P JI 5 – Colchicine, azathioprine, steroid, cyclophosphamide Cyclophosphamide BD7 M + +/+ + + + + - DVT 14 – Colchicine, infliximab Colchicine, infliximab BD8 M + +/+ + + – + - JI 1 – Colchicine – BD9 F + +/+ + + + + P DVT, PE 9 Oral aphthae, arthralgia Colchicine … , steroid, infliximab Infliximab BD10 M negative +/+ + + + + P - 8 – Colchicine, azathioprine, steroid, infliximab Colchicine, infliximab BD11 M + +/+ + + – + - DVT 8 – Colchicine, steroid, interferon alpha, cyclophosphamide – BD12 M + +/+ + + + + - DVT, JI 7 – Colchicine, coumadin, infliximab, depocilin …

The efficacy and safety of thalidomide in the treatment of refractory Crohn's disease in adults: a double-center, double-blind, randomized-controlled trial.

BACKGROUND: Thalidomide is applied in therapy for refractory Crohn's disease (CD) in adults, but systematic and rigorous clinical evidence is scant. The aim was to provide theoretical references for the efficacy of thalidomide in the therapy for refractory CD in adults. METHODS: A double-center, double-blind, placebo-controlled, randomized clinical trial of refractory CD in adults in two inflammatory bowel disease centers in China. In the double-blind trial, patients were randomly assigned to 100 mg of thalidomide or placebo daily for 8 weeks. The primary outcome was considered as the clinica

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… Consistently with previous findings, the use of infliximab in refractory CD patients did not influence the time to achieve clinical remission [ 10 , 19 ]. … Although infliximab, adalimumab, and thalidomide all exert their pharmacological functions through suppressing TNF-α, the specific mechanisms may vary a lot [ 20 ]. …

Mass Spectrometry Approaches for Identification and Quantitation of Therapeutic Monoclonal Antibodies in the Clinical Laboratory.

Therapeutic monoclonal antibodies (MAbs) are an important class of drugs used to treat diseases ranging from autoimmune disorders to B cell lymphomas to other rare conditions thought to be untreatable in the past. Many advances have been made in the characterization of immunoglobulins as a result of pharmaceutical companies investing in technologies that allow them to better understand MAbs during the development phase. Mass spectrometry is one of the new advancements utilized extensively by pharma to analyze MAbs and is now beginning to be applied in the clinical laboratory setting. The rise

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… Vande Casteele N , Buurman DJ , Sturkenboom MG , Kleibeuker JH , Vermeire S , Rispens T , van der Kleij D , Gils A , Dijkstra G 2012 Detection of infliximab levels and anti-infliximab antibodies: a comparison of three different assays . … Wang SL , Ohrmund L , Hauenstein S , Salbato J , Reddy R , Monk P , Lockton S , Ling N , Singh S 2012 Development and validation of a homogeneous mobility shift assay for the measurement of infliximab and antibodies-to-infliximab levels in patient serum . …