OBJECTIVES: To compare the drug survival of etanercept to monoclonal tumour necrosis factor-α inhibitors in rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis. METHODS: Patients initiating first line biological therapy with tumour necrosis factor-α were propensity score matched and compared for drug survival with a Kaplan-Meier analysis. RESULTS: We matched 657 to 657 patients in rheumatoid arthritis, the median survival time on etanercept was 44.6 months vs. 36.8 months on monoclonal antibody tumour necrosis factor-α inhibitors, with a hazard ratio of 0.94, p = 0.416 We matched 187 to 356 patients in ankylosing spondylitis, the median survival time on etanercept was 75.1 compared to 68.0 months, hazard ratio of 0.78, p = 0.087 We matched 81 to 160 psoriatic arthritis patients, the median survival time on etanercept was 35.8. compared to 65.7 months, hazard ratio 1.61, p = 0.011. Patients treated with etanercept had significantly worse psoriasis scoring during follow up. CONCLUSIONS: We found comparable survival in rheumatoid arthritis and ankylosing spondylitis. In psoriatic arthritis, we found significantly shorter survival on etanercept, possibly due to worse response of skin and nail manifestations.

• MeSH
• Adalimumab therapeutic use   MeSH
• Spondylitis, Ankylosing * drug therapy   mortality   MeSH
• Antirheumatic Agents * therapeutic use   MeSH
• Adult MeSH
• Etanercept * therapeutic use   MeSH
• Infliximab therapeutic use   MeSH
• Kaplan-Meier Estimate MeSH
• Middle Aged MeSH
• Humans MeSH
• Antibodies, Monoclonal therapeutic use   MeSH
• Arthritis, Psoriatic * drug therapy   mortality   MeSH
• Registries * MeSH
• Arthritis, Rheumatoid * drug therapy   mortality   MeSH
• Aged MeSH
• Propensity Score * MeSH
• Tumor Necrosis Factor-alpha * antagonists & inhibitors   MeSH
• Check Tag
• Adult MeSH
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Comparative Study MeSH
• Geographicals
• Czech Republic MeSH

BACKGROUND: Although biologic agents are very effective, long-term comparative studies demonstrating their safety relative to one another are still lacking. METHODS: A total of 124 patients with psoriasis were followed up for 30 months; 74 received anti-TNF-alpha inhibitors (adalimumab, etanercept, infliximab), 33 were on ustekinumab, and 17 were treated with secukinumab. The rates of adverse events in these groups were recorded and statistically analyzed. RESULTS: Infliximab-treated patients showed a high occurrence of asymptomatic, but increased liver enzymes, fatigue, and respiratory as well as dermatologic infections. Adalimumab-treated patients were more often affected by musculoskeletal disorders and infections of all types. Patients treated with secukinumab presented with higher rates of cardiovascular disorders as well as respiratory and dermatologic infections. The group receiving etanercept was more often diagnosed with musculoskeletal and reproductive disorders, specifically menstrual disorders. The rates of therapy discontinuation and serious adverse events did not reach statistically significant values. CONCLUSION: A higher incidence of adverse events was observed among adalimumab-, and infliximab-treated patients, with ustekinumab found to have the safest profile. Our results demonstrate that a personalized approach, including evaluation of a patient's risk profile, is necessary before commencing a biologic. Further research is warranted to confirm the findings of our study.

• MeSH
• Adalimumab * adverse effects   therapeutic use   MeSH
• Dermatologic Agents adverse effects   therapeutic use   MeSH
• Adult MeSH
• Etanercept * adverse effects   therapeutic use   MeSH
• Antibodies, Monoclonal, Humanized * adverse effects   therapeutic use   MeSH
• Infliximab * adverse effects   therapeutic use   MeSH
• Cohort Studies MeSH
• Middle Aged MeSH
• Humans MeSH
• Antibodies, Monoclonal adverse effects   therapeutic use   MeSH
• Prospective Studies MeSH
• Psoriasis * drug therapy   MeSH
• Ustekinumab * therapeutic use   adverse effects   MeSH
• Check Tag
• Adult MeSH
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Observational Study MeSH

Rozvoj biotechnologií a genetického inženýrství na konci minulého tisíciletí přinesl přelom v terapii nemocných se zánětlivými revmatickými chorobami, u kterých selhala terapie konvenčními syntetickými chorobu modifikujícími antirevmatickými léky (conventional synthetic disease modifying anti-rheumatic drug csDMARD). Nástup biologické terapie zlepšil prognózu a kvalitu života pacientů, ale přinesl ekonomickou zátěž spojenou s dosud celosvětově vysokou cenou této léčby. Narůstající potřeba biologických chorobu modifikujících antirevmatických léků (biological disease modifying anti-rheumatic drug, bDMARD) a jejich cena vedla po vypršení patentu na originální bDMARD k nástupu biosimilárních léků (biosimilar disease modifying anti-rheumatic drug, bsDMARD). Vzhledem k složité proteinové struktuře nelze bsDMARD považovat za tradiční generika, ale vysoce podobné kopie bDMARD, ze kterých vycházejí. Účinnost, bezpečnost a biosimilarita srovnatelná s originálním bDMARD musí být prokázána prostřednictvím klinických sledování před zavedení bsDMARD do klinické praxe. Předpokládá se, že cenově dostupnější bsDMARD umožní celosvětově širší dostupnost a udržitelnost léčby. Schválení prvního bsDMARD CT-P13 (biosimilární infliximab) se stalo přelomovou událostí, která umožnila rozvoj dalších bsDMARD. Tento článek se zabývá vybranými bsDMARD využívaných v současnosti v terapii zánětlivých revmatických onemocnění v České republice.

The advent of biotechnology and genetic engineering at the close of the last millennium marked a significant advancement in the treatment of patients with inflammatory rheumatic diseases, particularly when conventional disease-modifying drug therapy (csDMARD) had proven ineffective. The introduction of biological therapies (bDMARDs) has improved patient prognosis and quality of life, yet it has also resulted in an economic burden due to the persistently high cost of these treatments globally. The growing demand for bDMARDs and their associated costs have facilitated the emergence of biosimilars (bsDMARDs) following the expiration of the original bDMARDs patents. Given their complex protein structure, bsDMARDs should not be considered as traditional generics but rather as highly similar replicas of the original bDMARDs. Efficacy, safety, and biosimilarity to the original bDMARD must be demonstrated through clinical monitoring before bsDMARDs can be incorporated into clinical practice. The introduction of more affordable bsDMARDs is expected to expand treatment accessibility and sustainability worldwide. The approval of the first bsDMARD, CT-P13 (biosimilar infliximab), was a pivotal event, paving the way for the development of additional bsDMARDs. This article focuses on selected bsDMARDs currently used in the treatment of inflammatory rheumatic diseases in the Czech Republic.

• MeSH
• Adalimumab administration & dosage   pharmacology   therapeutic use   MeSH
• Biological Therapy methods   MeSH
• Biosimilar Pharmaceuticals * pharmacology   MeSH
• Etanercept administration & dosage   pharmacology   therapeutic use   MeSH
• Infliximab administration & dosage   pharmacology   therapeutic use   MeSH
• Clinical Studies as Topic MeSH
• Humans MeSH
• Rituximab administration & dosage   pharmacology   therapeutic use   MeSH
• Check Tag
• Humans MeSH
• Publication type
• Research Support, Non-U.S. Gov't MeSH
• Review MeSH

Introduction: "Ankylosing spondylitis (AS)" is an inflammatory disorder that affects the axial skeleton, peripheral joints, as well as entheses, resulting in significant disability. "Tumor necrosis factor-α (TNF-α)" inhibitors are regarded to be a helpful treatment for patients with active "AS". This study aimed to investigate the effectiveness and response rate of "etanercept" in a group of patients with "ankylosing spondylitis" in Mosul, Iraq.Methods: A prospective, "open-labeled", non-randomized 12 weeks study was undertaken on 43 participants with "ankylosing spondylitis" in the "Rheumatology unit" of "Ibn Sina Teaching Hospital", and the diagnosis was made using the "modified New York criteria". Participants were assessed at the outset of the study, week 4, and week 12 after receiving etanercept 50mg subcutaneously once weekly. The "Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)" was utilized to assess disease activity, while the "Bath Ankylosing Spondylitis Function Index" was utilized to assess functional status (BASFI) at baseline, 4 weeks, and 12 weeks. BASDAI 50 was used to assess the response rate.Results: Mean patients' age was "36.6±8.47" years; men accounted for "90.7 %" of the cases, with the mean disease length being "9.6±5.90" years. A marked decrease in BASFI and BASDAI was found four and twelve weeks after commencing treatment compared to baseline (p=0.000). "BASDAI 50 %" response was fulfilled by 42.5 % of the participants after 4 weeks and by 65%% after 12 weeks of therapy with "etanercept". There was a marked fall in the mean ESR and CRP after four and twelve weeks of "etanercept" therapy.Conclusion: In "AS" patients, once weekly "etanercept" 50 mg given subcutaneously for twelve weeks was an effective therapy.

• MeSH
• Spondylitis, Ankylosing * diagnosis   drug therapy   MeSH
• C-Reactive Protein analysis   MeSH
• Adult MeSH
• Etanercept * administration & dosage   therapeutic use   MeSH
• Tumor Necrosis Factor Inhibitors therapeutic use   MeSH
• Blood Sedimentation MeSH
• Middle Aged MeSH
• Humans MeSH
• Prospective Studies MeSH
• Severity of Illness Index MeSH
• Treatment Outcome MeSH
• Check Tag
• Adult MeSH
• Middle Aged MeSH
• Humans MeSH

Léčba biologickými chorobu modifikujícími antirevmatickými léky (biological disease modifying antirheumatic drug, bDMARD) má zásadní postavení v terapii zánětlivých revmatických onemocnění, u kterých selhala předchozí léčba konvenčními syntetickými chorobu modifikujícími léky. Narůstající potřeba bDMARD a jejich cena vedla po vypršení patentu na originální bDMARD k nástupu biosimilárních léků (bsDMARD). Jedná se o relativně novou skupinu léků, kterou lze definovat podle jejich podobnosti originálním bDMARD. Vzhledem k složité proteinové struktuře nelze bsDMARD považovat za tradiční generika, ale vysoce podobné kopie proteinů, ze kterých vycházejí. Na rozdíl o generických léčiv musejí bsDMARD prokázat před zavedením do praxe svou biosimilaritu s originálem prostřednictvím klinických sledování zaměřených na celou řadu faktorů porovnávajících dané přípravky. Nyní jsou již k dispozici více než desetiletá data jak z klinických sledování a jejich extenzí, tak z národních a nadnárodních registrů biologické léčby prokazující dobrou kvalitu, účinnost i bezpečnost bsDMARD shodnou s bDMARD. Cílem práce je podat stručný přehled o bsDMARD v současnosti využívaných v revmatologické praxi v České republice, lze však očekávat, že v době publikace článku se seznam bDMARD může rozšířit o další přípravky.

Treatment with biological disease modifying antirheumatic drugs (bDMARD) has a fundamental position in the therapy of inflammatory rheumatic diseases in which previous treatment with conventional synthetic disease modifying antirheumatic drugs has failed. The increasing need for bDMARDs and their price led to the emergence of biosimilar drugs (bsDMARDs) after the patent expiration of the original bDMARDs. This is a relatively new class of drugs that can be defined by their similarity to the original bDMARDs. Due to the complex protein structure, bsDMARDs cannot be considered traditional generics, but highly similar copies of the proteins from which they are derived. Unlike generic drugs, bsDMARDs must prove their biosimilarity with the original before being put into practice through clinical monitoring focused on a whole range of factors comparing the given preparations. More than ten years of data are now available both from clinical follow-ups and their extensions, as well as from national and international biologic treatment registries demonstrating the good quality, efficacy and safety of bsDMARDs on a par with bDMARDs. The aim of the work is to provide a brief overview of bsDMARDs currently used in rheumatology practice in the Czech Republic, however, it can be expected that by the time the article is published, the list of bsDMARDs may be expanded to include other preparations.

• MeSH
• Adalimumab pharmacology   therapeutic use   MeSH
• Spondylitis, Ankylosing drug therapy   MeSH
• Antirheumatic Agents pharmacology   classification   therapeutic use   MeSH
• Biological Therapy MeSH
• Biosimilar Pharmaceuticals * classification   therapeutic use   MeSH
• Etanercept pharmacology   therapeutic use   MeSH
• Infliximab administration & dosage   pharmacology   MeSH
• Clinical Studies as Topic MeSH
• Humans MeSH
• Rheumatic Diseases * drug therapy   MeSH
• Arthritis, Rheumatoid drug therapy   MeSH
• Rituximab pharmacology   therapeutic use   MeSH
• Treatment Outcome MeSH
• Check Tag
• Humans MeSH
• Publication type
• Research Support, Non-U.S. Gov't MeSH
• Review MeSH

• Keywords
• Benepali (etanercept),
• MeSH
• Spondylitis, Ankylosing drug therapy   MeSH
• Biosimilar Pharmaceuticals * therapeutic use   MeSH
• Etanercept therapeutic use   MeSH
• Humans MeSH
• Arthritis, Psoriatic drug therapy   MeSH
• Arthritis, Rheumatoid drug therapy   MeSH
• Severity of Illness Index MeSH
• Check Tag
• Humans MeSH

• Keywords
• Benepali (etanercept),
• MeSH
• Spondylitis, Ankylosing * diagnostic imaging   drug therapy   MeSH
• Antirheumatic Agents therapeutic use   MeSH
• Adult MeSH
• Etanercept administration & dosage   adverse effects   MeSH
• Infliximab administration & dosage   MeSH
• Humans MeSH
• Young Adult MeSH
• Drug Substitution MeSH
• Tumor Necrosis Factor-alpha antagonists & inhibitors   MeSH
• Skin Diseases, Vesiculobullous chemically induced   epidemiology   MeSH
• Treatment Outcome MeSH
• Check Tag
• Adult MeSH
• Humans MeSH
• Young Adult MeSH
• Male MeSH
• Publication type
• Case Reports MeSH

OBJECTIVE: To describe risk factors for IBD development in a cohort of children with JIA. METHODS: JIA patients who developed IBD were identified from the international Pharmachild register. Characteristics were compared between IBD and non-IBD patients and predictors of IBD were determined using multivariable logistic regression analysis. Incidence rates of IBD events on different DMARDs were calculated, and differences between therapies were expressed as relative risks (RR). RESULTS: Out of 8942 patients, 48 (0.54% ) developed IBD. These were more often male (47.9% vs 32.0%) and HLA-B27 positive (38.2% vs 21.0%) and older at JIA onset (median 8.94 vs 5.33 years) than patients without IBD development. They also had more often a family history of autoimmune disease (42.6% vs 24.4%) and enthesitis-related arthritis (39.6% vs 10.8%). The strongest predictors of IBD on multivariable analysis were enthesitis-related arthritis [odds ratio (OR): 3.68, 95% CI: 1.41, 9.40] and a family history of autoimmune disease (OR: 2.27, 95% CI: 1.12, 4.54). Compared with methotrexate monotherapy, the incidence of IBD on etanercept monotherapy (RR: 7.69, 95% CI: 1.99, 29.74), etanercept with methotrexate (RR: 5.70, 95% CI: 1.42, 22.77) and infliximab (RR: 7.61, 95% CI: 1.27, 45.57) therapy was significantly higher. Incidence on adalimumab was not significantly different (RR: 1.45, 95% CI: 0.15, 13.89). CONCLUSION: IBD in JIA was associated with enthesitis-related arthritis and a family history of autoimmune disease. An increased IBD incidence was observed for etanercept therapy regardless of concomitant methotrexate use.

• MeSH
• Antirheumatic Agents * adverse effects   MeSH
• Child MeSH
• Etanercept adverse effects   MeSH
• Inflammatory Bowel Diseases * drug therapy   epidemiology   MeSH
• Incidence MeSH
• Arthritis, Juvenile * drug therapy   epidemiology   MeSH
• Humans MeSH
• Methotrexate therapeutic use   MeSH
• Registries MeSH
• Check Tag
• Child MeSH
• Humans MeSH
• Male MeSH
• Publication type
• Journal Article MeSH
• Research Support, Non-U.S. Gov't MeSH

• Keywords
• tofacitinib,
• MeSH
• Antirheumatic Agents * classification   therapeutic use   MeSH
• Adult MeSH
• Etanercept therapeutic use   MeSH
• Janus Kinase Inhibitors therapeutic use   MeSH
• Tumor Necrosis Factor Inhibitors therapeutic use   MeSH
• Cohort Studies MeSH
• Middle Aged MeSH
• Humans MeSH
• Treatment Failure MeSH
• Arthritis, Rheumatoid * drug therapy   MeSH
• Routinely Collected Health Data MeSH
• Aged MeSH
• Treatment Outcome MeSH
• Check Tag
• Adult MeSH
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged MeSH
• Female MeSH
• Geographicals
• Korea MeSH

• MeSH
• Safety MeSH
• Etanercept * administration & dosage   adverse effects   MeSH
• Arthritis, Juvenile * drug therapy   MeSH
• Humans MeSH
• Treatment Failure MeSH
• Drug-Related Side Effects and Adverse Reactions epidemiology   MeSH
• Routinely Collected Health Data MeSH
• Treatment Outcome MeSH
• Check Tag
• Humans MeSH
• Publication type
• Clinical Study MeSH
• Geographicals
• Germany MeSH