scholarly journals Successful long-term remission through tapering tocilizumab infusions: a single-center prospective study

2019 ◽  
Author(s):  
Chayma Ladhari ◽  
Pierre Le Blay ◽  
Thierry Vincent ◽  
Ahmed Larbi ◽  
Emma Rubenstein ◽  
...  
Keyword(s):  
Therapeutic Option ◽  
Sustained Remission ◽  
Single Center ◽  
Open Label ◽  
Open Label Study ◽  
Treatment Interval ◽  
Secondary Failure ◽  
Term Maintenance

Abstract Background: Strategic drug therapy for rheumatoid arthritis (RA) patients with prolonged remission is not well defined. According to recent guidelines, tapering biological Disease-Modifying Anti-Rheumatic Drugs (bDMARDs) may be considered. We aimed to evaluate the effectiveness of long-term maintenance of tocilizumab (TCZ) treatment after the progressive tapering of infusions. Methods: We conducted an exploratory, prospective, single-center, open-label study, on RA patients with sustained remission of at least 3 months and treated with TCZ infusions every 4 weeks. The initial re-treatment interval was extended to 6 weeks for the first 3 months. Thereafter, the spacing between infusions was determined by the clinician. Successful long-term maintenance following the tapering of TCZ infusions was defined by patients still treated after two years by TCZ with a minimum dosing interval of 5 weeks.Results: Thirteen patients were enrolled in the study. Eight out of thirteen were still treated by TCZ after two years. Successful long-term maintenance was possible in six patients, with four patients maintaining a re-treatment interval of 8-weeks or more. We observed 5 patients with TCZ withdrawal: one showing adverse drug reaction (neutropenia) and four with secondary failure. Patients achieving successful long-term maintenance with TCZ were significantly younger than those with secondary failure (p<0.05). In addition, RA patients with positive rheumatoid factor and anti-citrullinated peptide antibodies, experienced a significantly greater number of flares during our 2-year follow-up (p<0.01).Conclusions: A progressive tapering of TCZ infusions may be possible for many patients. However, larger studies, including more patients, are needed to confirm this therapeutic option.

scholarly journals Successful long-term remission through tapering tocilizumab infusions: a single center prospective study

2019 ◽  
Author(s):  
Chayma Ladhari ◽  
Pierre Le Blay ◽  
Thierry Vincent ◽  
Ahmed Larbi ◽  
Emma Rubenstein ◽  
...  
Keyword(s):  
Therapeutic Option ◽  
Sustained Remission ◽  
Single Center ◽  
Open Label ◽  
Open Label Study ◽  
Treatment Interval ◽  
Secondary Failure ◽  
Term Maintenance

Abstract Background Strategic drug therapy for rheumatoid arthritis (RA) patients with prolonged remission is not well defined. According to recent guidelines, tapering biological Disease Modifying Anti-Rheumatic Drugs (bDMARDs) may be considered. We aimed to evaluate the long-term maintenance of tocilizumab (TCZ) treatment after the progressive tapering of infusions. Methods We conducted an exploratory, prospective, single-center, open label study, on RA patients with sustained remission for at least 3 months and treated with TCZ infusions every 4 weeks. The initial re-treatment interval was 6 weeks for the first 3 months. Thereafter, the spacing between infusions was determined by the clinician. Successful long-term maintenance following the tapering of TCZ infusions was defined by patients still treated after two years by TCZ with a minimum dosing interval of 5 weeks. Results Thirteen patients were enrolled in the study. Eight out of thirteen were still treated by TCZ after two years. Successful long-term maintenance was possible in six patients, with four patients maintaining a re-treatment interval of 8-weeks or more. We observed 5 patients with TCZ withdrawal: one for adverse drug reaction (neutropenia) and four with secondary failure. Patients achieving successful long-term maintenance with TCZ were significantly younger than those with secondary failure (p<0.05). In addition, RA patients with positive rheumatoid factor and anti-citrullinated peptide antibodies, experienced a significantly greater number of flares during our 2-year follow-up (p<0.01). Conclusions A progressive tapering of TCZ infusions seems possible in most of the patients. However, larger studies, including more patients, are needed to confirm this therapeutic option.

scholarly journals Long-term follow-up of DYT1 dystonia patients treated by deep brain stimulation: An open-label study

2010 ◽  
Vol 25 (3) ◽  
pp. 289-299 ◽  
Author(s):  
Laura Cif ◽  
Xavier Vasques ◽  
Victoria Gonzalez ◽  
Patrice Ravel ◽  
Brigitte Biolsi ◽  
...  
Keyword(s):  
Deep Brain Stimulation ◽  
Brain Stimulation ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Dyt1 Dystonia ◽  
Long Term Follow Up ◽  
Deep Brain

scholarly journals Aripiprazole once-monthly 400 mg for long-term maintenance treatment of schizophrenia: a 52-week open-label study

2015 ◽  
Vol 1 (1) ◽  
Author(s):  
Timothy Peters-Strickland ◽  
Ross A Baker ◽  
Robert D McQuade ◽  
Na Jin ◽  
Anna Eramo ◽  
...  
Keyword(s):  
Maintenance Treatment ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Term Maintenance

P.3.d.035 Aripiprazole once-monthly for long-term maintenance treatment of schizophrenia: a 52-week open-label study

2014 ◽  
Vol 24 ◽  
pp. S542
Author(s):  
T. Peters-Strickland ◽  
R.A. Baker ◽  
R. McQuade ◽  
N. Jin ◽  
A. Eramo ◽  
...  
Keyword(s):  
Maintenance Treatment ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Term Maintenance

scholarly journals Rituximab in refractory myasthenia gravis: a prospective, open‐label study with long‐term follow‐up

2016 ◽  
Vol 3 (7) ◽  
pp. 552-555 ◽  
Author(s):  
Dustin Anderson ◽  
Cecile Phan ◽  
Wendy S. Johnston ◽  
Zaeem A. Siddiqi
Keyword(s):  
Myasthenia Gravis ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Long Term Follow Up

scholarly journals Long-term outcome of the humoral and cellular immune response of an H5N1 adjuvanted influenza vaccine in elderly persons: 2-year follow-up of a randomised open-label study

Trials ◽  
2014 ◽  
Vol 15 (1) ◽  
Author(s):  
Paul Gillard ◽  
Didier Giet ◽  
Stéphane Heijmans ◽  
Mamadou Dramé ◽  
Karl Walravens ◽  
...  
Keyword(s):  
Immune Response ◽  
Elderly Persons ◽  
Open Label ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Open Label Study ◽  
Label Study ◽  
Cellular Immune

scholarly journals Long-Term Effects of Ipragliflozin on Diabetic Nephropathy and Blood Pressure in Patients With Type 2 Diabetes: 104-Week Follow-up of an Open-Label Study

2018 ◽  
Vol 10 (9) ◽  
pp. 679-687 ◽  
Author(s):  
Daisuke Ito ◽  
Kazuyuki Inoue ◽  
Takashi Sumita ◽  
Keiko Hamaguchi ◽  
Kimie Kaneko ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Type 2 Diabetes ◽  
Diabetic Nephropathy ◽  
Long Term Effects ◽  
Open Label ◽  
Open Label Study ◽  
Label Study

scholarly journals Double anticholinergic therapy for refractory neurogenic and non-neurogenic detrusor overactivity in children: Long-term results of a prospective open-label study

2014 ◽  
Vol 8 (5-6) ◽  
pp. 175 ◽  
Author(s):  
Geneviève Nadeau ◽  
Annette Schröeder ◽  
Katherine Moore ◽  
Lucie Genois ◽  
Pascale Lamontagne ◽  
...  
Keyword(s):  
Side Effects ◽  
Detrusor Overactivity ◽  
Long Term Results ◽  
Open Label ◽  
Open Label Study ◽  
Insufficient Response ◽  
Maximal Pressure ◽  
Bladder Condition

Introduction: In this study, we optimize pharmacotherapy in children who failed anticholinergic monotherapy by simultaneous administration of 2 anticholinergics (oxybutynin and/or tolterodine and/or solifenacin).Methods: This report is an update of our previously published study on double anticholinergic regimen in children with refractory incontinence due to neurogenic (NDO) and non-neurogenic (DO) detrusor overactivity. Patients with an insufficient response (clinically/urodynamically) to an optimized dose of a single anticholinergic (oxybutynin or tolterodine) received a second anticholinergic (tolterodine or solifenacin), in addition to the pre-existing medication. The primary end-point was efficacy (continence) and the secondary end-points were tolerability and safety. The Patient Perception of Bladder Condition (PPBC) scale was used to rate subjective improvement of patients.Results: In total, 56 patients with DO (n = 31) or NDO (n = 25) were enrolled at a mean age of 11.4 ± 3.5 years and were followed for a minimum of 3 months. The duration of double treatment was 36 ± 23 months. Our results found that 23 patients became dry, 18 improved significantly and 15 improved moderately. Urodynamic capacity improved from 158 ± 87 mL to 359 ± 148 mL and maximal pressure of contractions decreased from 76 ± 24 to 22 ± 22 cmH2O (p < 0.0001). The overall success rate was 82%, since 10 patients discontinued treatment for unsatisfactory clinical response or bothersome side effects. No side effects were reported by 28 patients, mild side effects by 20, moderate side effects by 8; 2 patients withdrew from the study due to their side effects. Of the 35 patients who voided spontaneously, 8 developed post-void residuals (>20%).Conclusions: With a larger cohort and prospective follow-up, we reiterated that double anticholinergic regimen in children with DO or NDO refractory to anticholinergic monotherapy is a feasible and efficient approach. 

scholarly journals THU0295 LOW IMMUNOGENICITY IN PATIENTS WITH GIANT CELL ARTERITIS TREATED WITH TOCILIZUMAB: 3-YEAR RESULTS FROM THE RANDOMIZED CONTROLLED PORTION AND OPEN-LABEL FOLLOW-UP OF A PHASE 3 TRIAL

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 375.1-376
Author(s):  
M. Bao ◽  
N. L. Mallalieu ◽  
J. H. Stone
Keyword(s):  
Giant Cell Arteritis ◽  
Giant Cell ◽  
Sustained Remission ◽  
Open Label ◽  
Screening Assay ◽  
Randomized Controlled ◽  
Long Term Follow Up ◽  
Neutralizing Potential

Background:Tocilizumab (TCZ) has low immunogenicity in patients with rheumatoid arthritis.1The risk for immunogenicity remains to be determined in patients with giant cell arteritis (GCA) treated with TCZ. TCZ administered subcutaneously every week (QW) or every other week (Q2W) with 26-week prednisone tapering was superior to placebo (PBO) plus 26-week (PBO+26) or 52-week (PBO+52) prednisone tapering for the achievement of sustained remission in patients with GCA in the 52-week, double-blind part 1 of the GiACTA trial.2Part 2 was a 2-year open-label, long-term follow-up in which patients were treated at the investigators’ discretion; part 2 treatment could include initiation/termination of TCZ QW with or without glucocorticoids or methotrexate.Objectives:To investigate immunogenicity of TCZ QW and Q2W regimens in patients with GCA in combination with a 26-week prednisone taper regimen versus PBO+26 or PBO+52 over the course of the GiACTA study in the randomized controlled part 1 and long-term follow-up part 2.Methods:In parts 1 and 2 combined, anti–TCZ antibodies (ADA) and corresponding pharmacokinetic (PK) parameters were assessed in serum samples taken at scheduled times at weeks 0, 8, 24, 36, 52, 76, 100, 136, and 156 or at early withdrawal. Additional assessments were made for patients who interrupted blinded TCZ treatment for ≥4 weeks in part 1 and those who withdrew from the study because of anaphylaxis/hypersensitivity. All samples were tested by screening assay, and samples that were ADA positive were further analyzed by a confirmation assay to verify specificity. If the confirmation assay was positive, 2 additional tests were performed to characterize the detected ADA: a neutralizing assay to test the neutralizing potential of ADAs and an assay to determine whether the detected ADA were of the IgE isotype. Proportions of patients in whom ADA developed were summarized for the safety population.Results:Among evaluable patients (had baseline and ≥1 postbaseline ADA assessments and received ≥1 dose of study treatment) in part 1, ADA developed in 1 of 95 (1.1%) and 3 of 46 (6.5%) patients after TCZ QW and Q2W dosing, respectively. One of 49 (2.0%) and 1 of 47 (2.1%) in the PBO+26 and PBO+52 groups, respectively, tested positive for ADA but had not received TCZ and were considered false positives. In parts 1 and 2 combined, among 199 patients who received ≥1 dose of TCZ, 193 (97%) were evaluable (Table); TCZ-induced ADA developed in 13 of these patients (6.7%) postbaseline (4 during part 1, 9 during part 2). Of these 13 patients, 8 (4.1%) had ADA with neutralizing potential and 1 (0.5%) had IgE ADA. Most TCZ-induced ADA were transient. There was no clear impact of TCZ-induced ADA on TCZ PK (Figure). No patients with TCZ-induced ADA experienced anaphylaxis, hypersensitivity reactions, or injection site reactions, and none withdrew because of lack of efficacyConclusion:In patients with GCA, treatment-induced ADA developed in a minority of patients and had no impact on TCZ PK, efficacy, or safety. The immunogenicity of subcutaneous TCZ treatment was low, consistent with that observed in patients with RA.References:[1]Burmester GR et al.Ann Rheum Dis2017;76:1078-85.[2]Stone JH et al.N Engl J Med2017;377:317-28.Table.Immunogenicity in Patients Who Received TCZ (part 1 + part 2)Patients Who Received TCZN = 199BaselineEvaluable patients194 (97.5)Positive screening assay12 (6.0)Positive confirmation assay6 (3.0)PostbaselineEvaluable patients193 (97.0)Treatment-induced ADA13 (6.7)Characterizaton of ADANeutralizing potential8 (4.1)IgE1 (0.5)Data are number (%) of patients based on N at baseline and on number of evaluable patients postbaseline.Disclosure of Interests:Min Bao Shareholder of: Roche, Employee of: Genentech, Navita L. Mallalieu Shareholder of: Roche, Employee of: Roche, John H. Stone Grant/research support from: Roche, Consultant of: Roche

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