• Keywords
• Remicade,
• MeSH
• Crohn Disease therapy   MeSH
• Gastroenterology classification   methods   trends   MeSH
• Humans MeSH
• Antibodies, Monoclonal pharmacology   therapeutic use   MeSH
• Psoriasis drug therapy   therapy   MeSH
• Consumer Product Safety MeSH
• Tumor Necrosis Factor-alpha therapeutic use   MeSH
• Colitis, Ulcerative therapy   MeSH
• Check Tag
• Humans MeSH

OBJECTIVES: To compare the efficacy, safety, immunogenicity and pharmacokinetics (PK) of SB2 to the infliximab reference product (INF) in patients with moderate to severe rheumatoid arthritis (RA) despite methotrexate therapy. METHODS: This is a phase III, randomised, double-blind, multinational, multicentre parallel group study. Patients with moderate to severe RA despite methotrexate therapy were randomised in a 1:1 ratio to receive either SB2 or INF of 3 mg/kg. The primary end point was the American College of Rheumatology 20% (ACR20) response at week 30. Inclusion of the 95% CI of the ACR20 response difference within a ±15% margin was required for equivalence. RESULTS: 584 subjects were randomised into SB2 (N=291; 290 analysed) or INF (N=293). The ACR20 response at week 30 in the per-protocol set was 64.1% in SB2 versus 66.0% in INF. The adjusted rate difference was -1.88% (95% CI -10.26% to 6.51%), which was within the predefined equivalence margin. Other efficacy outcomes such as ACR50/70, disease activity score measured by 28 joints and European League against Rheumatism response were similar between SB2 and INF. The incidence of treatment-emergent adverse events was comparable (57.6% in SB2 vs 58.0% in INF) as well as the incidence of antidrug antibodies (ADA) to infliximab up to week 30 (55.1% in SB2 vs 49.7% in INF). The PK profile was similar between SB2 and INF. Efficacy, safety and PK by ADA subgroup were comparable between SB2 and INF. CONCLUSIONS: SB2 was equivalent to INF in terms of ACR20 response at week 30. SB2 was well tolerated with a comparable safety profile, immunogenicity and PK to INF. TRIAL REGISTRATION NUMBER: NCT01936181.

• MeSH
• Antirheumatic Agents adverse effects   pharmacokinetics   therapeutic use   MeSH
• Biosimilar Pharmaceuticals adverse effects   pharmacokinetics   therapeutic use   MeSH
• Adult MeSH
• Double-Blind Method MeSH
• Infliximab adverse effects   immunology   pharmacokinetics   therapeutic use   MeSH
• Middle Aged MeSH
• Humans MeSH
• Methotrexate therapeutic use   MeSH
• Antibodies blood   MeSH
• Arthritis, Rheumatoid drug therapy   MeSH
• Aged MeSH
• Severity of Illness Index MeSH
• Therapeutic Equivalency MeSH
• Treatment Outcome MeSH
• Check Tag
• Adult MeSH
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Clinical Trial, Phase III MeSH
• Multicenter Study MeSH
• Randomized Controlled Trial MeSH
• Comparative Study MeSH

• MeSH
• Immunoconjugates administration & dosage   pharmacology   therapeutic use   MeSH
• Middle Aged MeSH
• Humans MeSH
• Arthritis, Rheumatoid drug therapy   therapy   MeSH
• Treatment Outcome MeSH
• Check Tag
• Middle Aged MeSH
• Humans MeSH
• Female MeSH
• Publication type
• Case Reports MeSH

• MeSH
• Autoimmune Diseases MeSH
• Biological Therapy MeSH
• Infliximab pharmacokinetics   pharmacology   therapeutic use   MeSH
• Publication type
• Review MeSH

• Conspectus
• Farmacie. Farmakologie
• NML Fields
• farmacie a farmakologie
• alergologie a imunologie

Crohnova choroba (MC) je chronické črevné zápalové ochorenie, ktoré môže zahŕňať rôzne časti gastrointestinálneho traktu. Je charakterizované transmurálnymi črevnými léziami u geneticky predisponovaných jedincov. Neutralizujúca anti TNF-alfa, chimérická monoklonálna IgG1 protilátka infliximab, je indikovaná u pediatrických pacientov s MC refraktérnou na liečbu a fistulujúcou formou Crohnovej choroby. V súčasnosti klinické použitie infliximabu zahŕňa indukčnú sekvenciu 5 mg/kg v 0, 2 a 6 týždni, podávanú intravenózne s následným podaním každých 8 týždňov. Liečba vyžaduje starostlivé sledovanie pre možné vedľajšie účinky, predovšetkým infekcie a malignity. V súčasnosti boli popísané fatálne prípady výskytu hepatosplenického T-bunkového lymfómu u mladých pacientov liečených infliximabom spoločne s purínovými analógmi. FDA pokračuje v monitorovaní bezpečnosti Remicade.

Crohn‘s disease (CD) is a chronic inflammatory disease that may involve any part of the gastrointestinal tract, characterized by transmural intestinal lesion in a genetically susceptible host. Anti-TNF-alpha neutralising agent, infliximab, the chimeric monoclonal IgG1 antibody, is indicated for pediatric patients with CD and medically refractory luminal and fistulising disease. The present clinical practice for infliximab use is induction sequence of 5 mg/kg at 0, 2 and 6 weeks administered intravenously and followed by infusion every 8 weeks thereafter. Careful attention should be paid to the potential adverse events, especially infections and malignancy. Recently, fatal cases in young patients with hepatosplenic T-cell lymphoma treated with infliximab and concomitant purine analogs were reported. The FDA continues to monitor the safety of Remicade.

• MeSH
• Biosimilar Pharmaceuticals MeSH
• Drug Evaluation MeSH
• Infliximab MeSH
• Clinical Medicine MeSH
• Antibodies, Monoclonal MeSH
• Tumor Necrosis Factor-alpha antagonists & inhibitors   MeSH
• Publication type
• Review MeSH

• Conspectus
• Farmacie. Farmakologie
• NML Fields
• farmacie a farmakologie

• Keywords
• Remicade,
• MeSH
• Immunosuppressive Agents classification   therapeutic use   MeSH
• Infliximab MeSH
• Middle Aged MeSH
• Humans MeSH
• Antibodies, Monoclonal therapeutic use   MeSH
• Arthritis, Psoriatic drug therapy   MeSH
• Psoriasis drug therapy   MeSH
• Check Tag
• Middle Aged MeSH
• Humans MeSH
• Female MeSH
• Publication type
• Case Reports MeSH

Popisujeme případ 35leté ženy s mnoholetou nestabilní psoriázou, s atakami generalizace projevů a výraznými bolestmi kloubů při psoriatické artropatii. Tato pacientka byla poslední dva roky v péči revmatologa, který ji pro zhoršující se kloubní obtíže odeslal do centra pro biologickou léčbu psoriázy k posouzení možnosti léčby blokátorem tumor nekrotizujícího faktoru alfa (TNF-?). V přehledu uvádíme klinické výsledky léčby infliximabem (REMICADE) u psoriázy v průběhu 26 měsíců. Psoriatická artropatie je hodnocena pouze z hlediska ovlivnění intenzity bolesti kloubů.

A case of a 35-year-old woman is described who presented with many years of unstable psoriasis, periods of generalized manifestations and significant joint pains in psoriatic arthropathy. For the past two years, this patient has been cared for by a rheumatologist who referred her for worsening joint problems to the centre for biological therapy of psoriasis to assess the options of treatment with the tumour necrosis factor-alpha (TNF-?) blocker. The clinical outcomes of treatment with infliximab (REMICADE) in psoriasis during the course of 26 months are presented. Psoriatic arthropathy is evaluated only in terms of affecting the intensity of joint pain.

• Keywords
• Remicade,
• MeSH
• Biological Therapy MeSH
• Adult MeSH
• Humans MeSH
• Antibodies, Monoclonal therapeutic use   MeSH
• Arthritis, Psoriatic drug therapy   MeSH
• Psoriasis drug therapy   MeSH
• Tumor Necrosis Factor-alpha antagonists & inhibitors   MeSH
• Check Tag
• Adult MeSH
• Humans MeSH
• Female MeSH
• Publication type
• Case Reports MeSH

Neúčinnost „chorobu modifikujících“ farmak u části pacientů se zánětlivými artropatiemi a nepřesvědčivé výsledky studií sledujících radiologickou progresi urychlily snahu o vývoj nových, účinnějších farmak s cílem ovlivnit nejen klinickou aktivitu, ale i radiologickou progresi. Vývoj těchto nových farmak vychází ze znalostí klíčové role T- a B-lymfocytů a cytokinů produkovaných aktivovanými imunokompetentními buňkami v patogenezi zánětlivých artropatií. Mezi nejvýznamnější cytokiny patří faktor nekrotizující tumory (TNF?- „tumor necrosis factor ?“), interleukin-1 (IL-1) a interleukin-6 (IL-6). Tyto poznatky vedly k vývoji látek, specificky zaměřených na inhibici těchto buněk resp. jejich cytokinů, v prvé řadě TNF?. Léčba těmito farmaky se ukázala být vysoce účinnou u revmatoidní artritidy rezistentní na léčbu standardními „chorobu modifikujícími farmaky“ a to při sledování prakticky všech dostupných parametrů. Následovaly podobně dobré zkušenosti jsou i s léčbou spondylartritid, zejména psoriatické artritidy a ankylozující spondylitidy. V současné době jsou k dispozici 3 látky inhibující TNF?: infliximab (REMICADE), etanercept (ENBREL) a adalimumab (HUMIRA). Další výzkum na tomto poli vedl k vývoji farmak ovlivňujících aktivaci T-buněk na úrovni tzv. kostimulačních molekul (tzv. imunomodulátory, např. abatacept). Jiný přístup k „biologické léčbě“ představuje snaha ovlivnit aktivaci B-buněk, které rovněž hrají roli v genezi revmatoidní artritidy (rituximab).

The ineffectiveness of „disease-modifying“ drugs in a proportion of patients with inflammatory arthropathies and inconclusive results of studies investigating radiological progression have accelerated the efforts to develop new, more effective pharmaceuticals with an aim to affect not only clinical activity but also radiological progression. The development of these new pharmaceuticals is based on the knowledge of the key roles of T and B lymphocytes and cytokines produced by activated immunocompetent cells in the pathogenesis of inflammatory arthropathies. The most significant cytokines include tumor necrosis factor alpha (TNF?), interleukin-1 (IL-1), and interleukin-6 (IL-6). This knowledge has led to the development of substances specifically designed to inhibit these cells and/or their cytokines, primarily TNF?. Treatment with these pharmaceuticals has proved highly effective in rheumatoid arthritis resistant to treatment with standard „disease-modifying“ drugs in virtually all available parameters followed. Similarly positive experience has been gained with the treatment of spondylarthritides, particularly psoriatic arthritis and ankylosing spondylitis. Currently, three substances inhibiting TNF? are available: infliximab (REMICADE), etanercept (ENBREL), and adalimumab (HUMIRA). Further research in this field has led to the development of pharmaceuticals affecting T cell activation at the level of so-called costimulatory molecules (so-called immunomodulators such as abatacept). Another approach to „biological therapy“ is represented by an effort to affect activation of B cells that also play a role in the genesis of rheumatoid arthritis (rituximab).

• Keywords
• Fc-fusion protein, Remicade, Enbrel, Humira, Orencia,
• MeSH
• Abatacept MeSH
• Adalimumab MeSH
• Antirheumatic Agents pharmacology   MeSH
• Biological Therapy methods   trends   MeSH
• Denosumab MeSH
• Etanercept MeSH
• Immunoglobulin G MeSH
• Immunoconjugates MeSH
• Infliximab MeSH
• Humans MeSH
• RANK Ligand MeSH
• Inflammation Mediators MeSH
• Antibodies, Monoclonal MeSH
• Receptors, Tumor Necrosis Factor MeSH
• Recombinant Fusion Proteins MeSH
• Rheumatic Diseases drug therapy   MeSH
• Tumor Necrosis Factor-alpha drug effects   MeSH
• Check Tag
• Humans MeSH
• Publication type
• Review MeSH

• Keywords
• Remicade,
• MeSH
• Adult MeSH
• Infliximab MeSH
• Drug Therapy, Combination MeSH
• Humans MeSH
• Methotrexate administration & dosage   therapeutic use   MeSH
• Antibodies, Monoclonal adverse effects   therapeutic use   MeSH
• Arthritis, Psoriatic drug therapy   MeSH
• Psoriasis drug therapy   MeSH
• Check Tag
• Adult MeSH
• Humans MeSH
• Male MeSH
• Publication type
• Case Reports MeSH