Primer: assessing the efficacy and safety of nonpharmacologic treatments for chronic rheumatic diseases

2006 ◽  
Vol 2 (6) ◽  
pp. 313-319 ◽  
Author(s):  
Philippe Ravaud ◽  
Isabelle Boutron
Keyword(s):  
Rheumatic Diseases ◽  
Efficacy And Safety ◽  
Chronic Rheumatic Diseases

scholarly journals POS0630 COMPARISON OF THE EFFICACY AND SAFETY OF ORIGINAL AND BIOSIMILAR ADALIMUMAB MOLECULES IN CHILDHOOD RHEUMATIC DISEASES

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 553.1-553
Author(s):  
K. Ulu ◽  
F. Demir ◽  
T. Coşkuner ◽  
Ş. Çağlayan ◽  
B. Sözeri
Keyword(s):  
Adverse Events ◽  
Disease Activity ◽  
Rheumatic Diseases ◽  
Behcet’S Disease ◽  
Behçet's Disease ◽  
Inactive Disease ◽  
Efficacy And Safety ◽  
Serious Adverse Events ◽  
Significant Difference ◽  
Abp 501

Background:The TNF-α inhibitor adalimumab is a biological disease modifying anti-rheumatic drug (bDMARD) that has been used in different rheumatic diseases with a resistant course. ABP-501 is a biosimilar product (BP) of adalimumab, recently approved by the FDA and EMA. To our knowledge, there is no study assess the efficacy and safety of these two molecules on pediatric patients.Objectives:We aimed to compare the efficacy and safety of the original and biosimilar adalimumab (ABP-501) molecules in childhood rheumatic diseases.Methods:This non-interventional, retrospective, single-centre analysis carried out in Umraniye Training and Resrach Hospital, Pediatric Rheumatology Clinic, Istanbul, Turkey. The study group consisted of patients who were followed due to chronic rheumatic disease between January 1, 2016 and June 1, 2020, and received reference or biosimilar adalimumab therapy for at least three months. Demographic and clinical data of patients were collected at baseline, 3rd, 6th, and 12th months of treatment. Disease activity assessment was made with JADAS-27 in JIA patients, with SUN criteria in uveitis patients, and with Behçet’s Disease Activity Index in BD patients. Efficacy and safety of treatments were compared between reference and biosimilar adalimumab groups.Results:A total of 89 patients (65 with original and 24 with biosimilar molecule) treated with adalimumab, were included in the study. There were 45 female and 44 male in the study, and the median age at the initiation of the adalimumab was 166 months (min-max: 36-231). Of the 89 patients evaluated, the primary diagnoses of 62 were juvenile idiopathic arthritis, 13 were idiopathic uveitis, eight were Behçet’s disease, three were Blau syndrome, two were chronic recurrent multifocal osteomyelitis and one was Vogt-Koyanagi-Harada syndrome. 63 of the patients were biologic-naïve, and 13 were switched from etanercept, 11 from infliximab, and two from other bDMARDs. The median exposure time of adalimumab was 16 months (min-max:3-70) in RP and 14.5 months (min-max: 3-23) in BP. All patients had active disease before treatment. In the group treated with RP, inactive disease was achieved in 60%, 76.6% and 87.2% of the patients at the 3rd, 6th and 12th months, respectively. Also, inactive disease was achieved in 62.5%, 78.2% and 78.2% of the patients at the 3rd, 6th and 12th months in the group treated with BP, respectively. There was no statistically significant difference in efficacy between the groups at the 3rd, 6th and 12th months (p=0.83, 0.07 and 0.32). Serious adverse events were seen in one patient in each groups (lymphoma in RP group, tuberculous meningitis in BP group). Non-serious adverse events were observed in eight patients (12.3%) in the RP group and in two patients (8.3%) in the BP group, without statistically significant difference between groups (p=0.86).Conclusion:No significant difference was observed between the biosimilar adalimumab ABP-501 and RP adalimumab in terms of efficacy and safety.References:[1]Renton, William D et al. Pediatr Rheumatol Online J. 2019;17(1):67.[2]Lovell DJ, Ruperto N, Goodman S, et al. N Engl J Med. 2008;359(8):810-820.[3]Kingsbury, Daniel J et al. Clin Rheumatol 2014;33(10):1433-41.Disclosure of Interests:None declared

Action from the CRM: barbiturates

1980 ◽  
Vol 18 (3) ◽  
pp. 9-11
Keyword(s):  
Rheumatic Diseases ◽  
Efficacy And Safety ◽  
Inflammatory Drugs ◽  
Anti Inflammatory

In 1975 the Committee on the Review of Medicines (CRM) began to examine the efficacy and safety of those drugs that were already on the market before 1971, when the present licensing procedures were introduced.1 It has already made recommendations on non-steroidal anti-inflammatory drugs2 and on other drugs used in rheumatic diseases,3 and these led to improvements in the data sheets for these products but had no obvious effects in practice. However, with its most recent recommendations on barbiturates, the CRM is showing its teeth.

Serum Globulin Fractions in Chronic Rheumatic Diseases

1956 ◽  
Vol 2 (1) ◽  
pp. 35-44 ◽  
Author(s):  
Harold B Salt
Keyword(s):  
Serum Protein ◽  
Rheumatic Diseases ◽  
Protein Patterns ◽  
Serum Globulin ◽  
Salting Out ◽  
Abnormal Protein ◽  
Fractionation Procedure ◽  
Chronic Rheumatic Diseases ◽  
Salt Fractionation

Abstract Investigations into the serum protein patterns that occur in chronic rheumatic diseases, formerly made by salt-fractionation methods, are now revised with the aid of the superior technic of microelectrophoretic separation. Using the microelectrophoretic method, supplemented by a single salt-fractionation procedure, the concentrations of albumin, α1-globulin, α2-globulin, β-globulin and γ-globulin in the sera of 26 patients variously affected by chronic rheumatic diseases were determined. Normal protein patterns were found in all the 12 sera with normal total globulin content, whereas variously abnormal protein patterns were found in all of the 14 hyperglobulinemic sera. The hyperglobulinemia of chronic rheumatic diseases was found most frequently to be due to increments in γ-globulin, often accompanied also by increases in α2-globulin. Less frequently, increased amounts of β-globulin were found, and in some cases an elevation of α1-globulin. These abnormalities were all detectable electrophoretically, whereas the method for the salting-out of γ-globulin was unsatisfactory.

scholarly journals AB1016 OUTCOME OF TRANSITION OF CARE IN YOUNG ADULTS WITH JUVENILE ONSET CHRONIC RHEUMATIC DISEASES

2019 ◽  
Author(s):  
Patrícia Martins ◽  
Sofia C. Barreira ◽  
Ana Teresa Melo ◽  
Raquel Campanilho-Marques ◽  
Joao Eurico Fonseca ◽  
...  
Keyword(s):  
Young Adults ◽  
Rheumatic Diseases ◽  
Transition Of Care ◽  
Juvenile Onset ◽  
Chronic Rheumatic Diseases

scholarly journals Adverse drug reactions associated with treatment in patients with chronic rheumatic diseases in childhood: a retrospective real life review of a single center cohort

2020 ◽  
Vol 60 (1) ◽  
Author(s):  
Manar Amanouil Said ◽  
Liana Soido Teixeira e Silva ◽  
Aline Maria de Oliveira Rocha ◽  
Gustavo Guimarães Barreto Alves ◽  
Daniela Gerent Petry Piotto ◽  
...  
Keyword(s):  
Risk Factors ◽  
Regression Model ◽  
Children And Adolescents ◽  
Adverse Drug Reactions ◽  
Rheumatic Diseases ◽  
Real Life ◽  
Drug Reactions ◽  
Wide Range ◽  
Disease Modifying ◽  
Chronic Rheumatic Diseases

Abstract Background Adverse drug reactions (ADRs) are the sixth leading causes of death worldwide; monitoring them is fundamental, especially in patients with disorders like chronic rheumatic diseases (CRDs). The study aimed to describe the ADRs investigating their severity and associated factors and resulting interventions in pediatric patients with CRDs. Methods A retrospective, descriptive and analytical study was conducted on a cohort of children and adolescents with juvenile idiopathic arthritis (JIA), juvenile systemic lupus erythematosus (JSLE) and juvenile dermatomyositis (JDM). The study evaluated medical records of the patients to determine the causality and the management of ADRs. In order to investigate the risk factors that would increase the risk of ADRs, a logistic regression model was carried out on a group of patients treated with the main used drug. Results We observed 949 ADRs in 547 patients studied. Methotrexate (MTX) was the most frequently used medication and also the cause of the most ADRs, which occurred in 63.3% of patients, followed by glucocorticoids (GCs). Comparing synthetic disease-modifying anti-rheumatic drugs (sDMARDs) vs biologic disease-modifying anti-rheumatic drugs (bDMARDs), the ADRs attributed to the former were by far higher than the latter. In general, the severity of ADRs was moderate and manageable. Drug withdrawal occurred in almost a quarter of the cases. In terms of risk factors, most patients who experienced ADRs due to MTX, were 16 years old or younger and received MTX in doses equal or higher than 0.6 mg/kg/week. Patients with JIA and JDM had a lower risk of ADRs than patients with JSLE. In the multiple regression model, the use of GCs for over 6 months led to an increase of 0.5% in the number of ADRs. Conclusions Although the ADRs highly likely affect a wide range of children and adolescents with CRDs they were considered moderate and manageable cases mostly. However, triggers of ADRs need further investigations.

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