scholarly journals Long term efficacy and safety of cyclosporin versus parenteral gold in early rheumatoid arthritis: a three year study of radiographic progression, renal function, and arterial hypertension

2002 ◽  
Vol 61 (6) ◽  
pp. 511-516 ◽  
Author(s):  
T K Kvien
Keyword(s):  
Rheumatoid Arthritis ◽  
Renal Function ◽  
Arterial Hypertension ◽  
Early Rheumatoid Arthritis ◽  
Radiographic Progression ◽  
Efficacy And Safety ◽  
Term Efficacy

Long-Term Efficacy and Safety of Deferasirox (Exjade®, ICL670), a Once-Daily Oral Iron Chelator, in Patients with Sickle Cell Disease (SCD).

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 3395-3395 ◽  
Author(s):  
Elliott Vichinsky ◽  
Thomas D. Coates ◽  
Alexis A. Thompson ◽  
Brigitta U. Mueller ◽  
Darlene Lagrone ◽  
...  
Keyword(s):  
Renal Function ◽  
Skin Rash ◽  
Extension Phase ◽  
Extension Study ◽  
Efficacy And Safety ◽  
Once Daily ◽  
Term Efficacy ◽  
Core Phase ◽  
Dose Dependent

Abstract Background: Many patients with SCD require acute or chronic transfusions to manage serious crises or prevent stroke. With age, there is also a risk of progressive renal dysfunction. A 1-year comparative study (109) in iron-overloaded patients with SCD demonstrated similar dose-dependent liver iron concentration (LIC) reductions with once-daily oral deferasirox and deferoxamine (DFO). This analysis presents cumulative long-term efficacy and safety data for patients with SCD receiving deferasirox treatment in a 4-year extension trial. Methods: In the 1-year core phase, deferasirox and DFO doses were assigned according to baseline LIC. In the extension study, patients either continued treatment with deferasirox (deferasirox cohort) or crossed over from DFO to deferasirox (crossover cohort). Patients with abnormal renal function were excluded. Dose adjustments during the extension phase were based on weight changes, serum ferritin (SF), creatinine, liver function tests and skin rash. Efficacy was determined by monthly SF; safety assessments included all adverse event (AE) monitoring, lab parameters, and ocular, auditory, and physical exams. Data were analyzed with a cut-off of 31 March 2007. Results: 185 patients entered the extension phase, 132 patients in the deferasirox cohort and 53 patients in the crossover cohort. Patients in the deferasirox cohort have received treatment for a median of 2.1 years. There have been 33 discontinuations (26 deferasirox, 7 crossover patients; 18%) due to: AEs (10), consent withdrawal (12), lost to follow-up (8), unsatisfactory chelation (2), and other (1). Only 1 patient has discontinued in the past 12 months due to pregnancy. No deaths have occurred during this study. In the deferasirox cohort, patients who initially received deferasirox 5/10 mg/kg/d had an increase from baseline in median SF levels at 12 months (+50 ng/mL; baseline 2805 ng/mL), which gradually declined and reached baseline at 24 months (−140 ng/mL) following a dose increase to approximately 20 mg/kg/d (starting at 12 months). SF was either maintained or reduced from baseline in the initial 20 and 30 mg/kg/d dose groups. Patients continue to receive deferasirox treatment in the extension phase trial and, as more data accumulate, the long-term effect of deferasirox at doses of 20–30 mg/kg/day will continue to be assessed. There were no significant changes in markers of liver or renal function in either cohort, and no cases of progressive increases in serum creatinine. The most frequent AEs were vomiting (n=10), nausea (n=23), and diarrhea (n=19); 9 patients experienced skin rash. Most AEs were mild and occurred during the core phase, with a steady decrease in incidence during the extension. No new AEs or safety concerns have been reported thus far in the extension study. Conclusions: Deferasirox demonstrates dose-dependent efficacy in patients with SCD, with a manageable tolerability profile and no new AEs reported over a median of 2.1 years of treatment.

AB0458 Tocilizumab: Analysis of Long-Term Efficacy and Safety in Rheumatoid Arthritis Patients: Table 1

2015 ◽  
Vol 74 (Suppl 2) ◽  
pp. 1049.1-1049
Author(s):  
I. Chalmeta Verdejo ◽  
L. González Puig ◽  
E. Labrador Sánchez ◽  
C.M. Feced Olmos ◽  
E. Grau Garcia ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Efficacy And Safety ◽  
Term Efficacy

scholarly journals Long-Term Efficacy and Safety of Biosimilar CT-P10 Versus Innovator Rituximab in Rheumatoid Arthritis: 48-Week Results from a Randomized Phase III Trial

BioDrugs ◽  
2019 ◽  
Vol 33 (1) ◽  
pp. 79-91 ◽  
Author(s):  
Chang-Hee Suh ◽  
Dae Hyun Yoo ◽  
Alfredo Berrocal Kasay ◽  
Elia Chalouhi El-Khouri ◽  
Francisco Fidenci Cons Molina ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Phase Iii Trial ◽  
Term Efficacy

scholarly journals Have radiographic progression rates in early rheumatoid arthritis changed? A systematic review and meta-analysis of long-term cohorts

Rheumatology ◽  
2016 ◽  
Vol 55 (6) ◽  
pp. 1053-1065 ◽  
Author(s):  
Lewis Carpenter ◽  
Elena Nikiphorou ◽  
Rachel Sharpe ◽  
Sam Norton ◽  
Kirsten Rennie ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Systematic Review ◽  
Early Rheumatoid Arthritis ◽  
Radiographic Progression ◽  
Meta Analysis

scholarly journals Long-term efficacy and safety in patients with rheumatoid arthritis continuing on SB4 or switching from reference etanercept to SB4

2017 ◽  
Vol 76 (12) ◽  
pp. 1986-1991 ◽  
Author(s):  
Paul Emery ◽  
Jiří Vencovský ◽  
Anna Sylwestrzak ◽  
Piotr Leszczyński ◽  
Wieslawa Porawska ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Response Rates ◽  
Comparable Efficacy ◽  
Efficacy And Safety ◽  
Open Label ◽  
Double Blind ◽  
Term Efficacy ◽  
Open Label Extension ◽  
Extension Period

ObjectivesSB4 (Benepali, Brenzys) is a biosimilar of reference etanercept (ETN). In a randomised, double-blind, 52-week study, SB4 demonstrated comparable efficacy and safety to ETN in patients with rheumatoid arthritis (RA). The open-label extension period evaluated long-term efficacy, safety and immunogenicity when continuing SB4 versus switching from ETN to SB4.MethodsIn the randomised, double-blind phase, patients received weekly subcutaneous administration of 50 mg SB4 or ETN with background methotrexate for up to 52 weeks. Patients in the Czech Republic and Poland who completed the 52-week visit were enrolled in the open-label extension period and received SB4 for 48 additional weeks. Efficacy, safety and immunogenicity were assessed up to week 100.ResultsOf 245 patients entering the extension period, 126 continued to receive SB4 (SB4/SB4) and 119 switched to SB4 (ETN/SB4). American College of Rheumatology (ACR) response rates were sustained and comparable between SB4/SB4 and ETN/SB4 with ACR20 response rates at week 100 of 77.9% and 79.1%, respectively. Other efficacy results, including radiographic progression, were also comparable between the groups. After week 52, rates of treatment-emergent adverse events were 47.6% (SB4/SB4) and 48.7% (ETN/SB4); one patient/group developed non-neutralising antidrug antibodies. No cases of active tuberculosis or injection-site reactions were reported during the extension period. One patient (SB4/SB4) died of hepatic cancer.ConclusionsSB4 was effective and well tolerated over 2 years in patients with RA. Efficacy, safety and immunogenicity were comparable between the SB4/SB4 and ETN/SB4 groups, showing no risk associated with switching patients from ETN to SB4.Trial registration numberNCT01895309; 2012-005026-30

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