scholarly journals Real-world outcomes for a complete nationwide cohort of more than 3200 teriflunomide-treated multiple sclerosis patients in The Danish Multiple Sclerosis Registry

PLoS ONE ◽  
2021 ◽  
Vol 16 (5) ◽  
pp. e0250820
Author(s):  
Viktoria Papp ◽  
Mathias Due Buron ◽  
Volkert Siersma ◽  
Peter Vestergaard Rasmussen ◽  
Zsolt Illes ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Real World ◽  
Population Based ◽  
Specific Patient ◽  
Treatment Start ◽  
Treatment Naïve ◽  
Previously Treated Patients ◽  
Previously Treated ◽  
Multiple Sclerosis Patients

Objective Teriflunomide is a once-daily, oral disease-modifying therapy (DMT) for relapsing forms of multiple sclerosis (MS). We studied clinical outcomes in a real-world setting involving a population-based large cohort of unselected patients enrolled in The Danish Multiple Sclerosis Registry (DMSR) who started teriflunomide treatment between 2013–2019. Methods This was a complete nationwide population-based cohort study with prospectively enrolled unselected cases. Demographic and disease-specific patient parameters related to treatment history, efficacy outcomes, and discontinuation and switching rates among other clinical variables were assessed at baseline and during follow-up visits. Results A total of 3239 patients (65.4% female) started treatment with teriflunomide during the study period, 56% of whom were treatment-naïve. Compared to previously treated patients, treatment-naïve patients were older on average at disease onset, had a shorter disease duration, a lower Expanded Disability Status Scale score at teriflunomide treatment start and more frequently experienced a relapse in the 12 months prior to teriflunomide initiation. In the 3001 patients initiating teriflunomide treatment at least 12 months before the cut-off date, 72.7% were still on treatment one year after treatment start. Discontinuations in the first year were due mainly to adverse events (15.6%). Over the full follow-up period, 47.5% of patients discontinued teriflunomide treatment. Sixty-three percent of the patients treated with teriflunomide for 5 years were relapse-free, while significantly more treatment-naïve versus previously treated patients experienced a relapse during the follow-up (p<0.0001). Furthermore, 85% of the patients with available data were free of disability worsening at the end of follow-up. Conclusions Solid efficacy and treatment persistence data consistent with other real-world studies were obtained over the treatment period. Treatment outcomes in this real-world scenario of the population-based cohort support previous findings that teriflunomide is an effective and generally well-tolerated DMT for relapsing MS patients with mild to moderate disease activity.

Overall survival results for durvalumab and savolitinib in metastatic papillary renal cancer.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 619-619 ◽  
Author(s):  
Cristina Suarez Rodriguez ◽  
James M. G. Larkin ◽  
Poulam Patel ◽  
Begona Pérez Valderrama ◽  
Alejo Rodriguez-Vida ◽  
...  
Keyword(s):  
Overall Survival ◽  
Renal Cancer ◽  
Progression Free Survival ◽  
Clinical Activity ◽  
Treatment Naïve ◽  
Previously Treated Patients ◽  
Previously Treated ◽  
Grade 3 ◽  
Treatment Safety

619 Background: There is a strong rationale for investigating MET and PD-L1 inhibition in metastatic papillary renal cancer (PRC). We previously reported response rates (RR) and progression free survival (PFS) for savolitinib (MET inhibitor) and durvalumab (PD-L1 inhibitor) together. Here we report overall survival (OS) data available 12 months after the last patient was enrolled. Methods: This single arm phase I/II trial explores durvalumab (1500mg Q4W) and savolitinib (600mg OD) together in PRC, with a 4wk savolitinib run in. Treatment naïve or previously treated patients with metastatic PRC were included. Confirmed RR (RECIST v1.1), PFS, tolerability (CTCAE v4.03) and overall survival (OS) were analysed. MET and PD-L1 biomarkers were explored (NCT02819596). Results: 42 patients were enrolled with 41 receiving at least one dose of study treatment. Safety and efficacy analyses were performed on these 41 patients. The median follow up was 14.3 months. IMDC good, intermediate and poor risk disease occurred in 29%, 63%, and 7% of patients respectively. Overall confirmed RR was 27% while median PFS was 4.9 months (95% CI: 2.5 – 12.0 months). Median OS was 12.3 months (95% CI: 5.8 – 21.3 months). Confirmed RR and median OS in the previously untreated cohort (N=27) were 33% and 12.3 months (95% CI: 4.7 – not reached (NR) months) respectively. Treatment related Grade 3/4 toxicity occurred in 34% of patients. No new safety signals were seen. PD-L1 and MET expression were not associated with higher RR (25% and 40% respectively) or longer OS. Conclusions: The combination of savolitinib and durvalumab has clinical activity in PRC and outcomes were not enhanced in biomarker positive cancers. Clinical trial information: NCT02819596.

scholarly journals Evaluation of 0.2 µg/day fluocinolone acetonide (ILUVIEN) implant in a cohort of previously treated patients with diabetic macular oedema (DMO): a 36-month follow-up clinical case series

2020 ◽  
Vol 5 (1) ◽  
pp. e000484
Author(s):  
Muna Ahmed ◽  
Christine Putri ◽  
Hibba Quhill ◽  
Fahd Quhill
Keyword(s):  
Clinical Practice ◽  
Real World ◽  
Macular Oedema ◽  
Case Series ◽  
Diabetic Macular Oedema ◽  
Fluocinolone Acetonide ◽  
Previously Treated Patients ◽  
Previously Treated ◽  
The Mean

ObjectiveTo assess the real-world effectiveness and safety of single injection of a fluocinolone acetonide (FAc) implant in previously treated patients with recurrent diabetic macular oedema (DMO) over a 36-month follow-up period.Methods and AnalysisThis is a retrospective study conducted at a single ophthalmology department at the Royal Hallamshire Hospital, Sheffield, UK. Data were collected using electronic medical records to identify all patients treated with a FAc implant for DMO between March 2014 and November 2014, followed with a 36-month clinic follow-up. Outcomes measured included mean change in best-recorded visual acuity (BRVA) and central macular thickness (CMT) over the period of 36 months, treatment burden pre-implant and post-implant, and functional and anatomical responder rates.ResultsTwenty-six eyes (n=22 patients) were treated with single intravitreal FAc implant followed with 36 months of follow-up. At 24 and 36 months, 86.4% and 75.0% of patients maintained or gained vision post-FAc implant in routine clinical practice. The mean BRVA increased from 41.8 to 54.6 letters at month 24 and 45.8 letters at month 36, with 50.0% and 33.3% of patients achieving a ≥15 letter improvement at months 24 and 36, respectively. The mean CMT reduced from 600.8 µm at baseline to 351.0 µm and 392.5 µm at months 24 and 36, respectively. Overall, a mean of one treatment every 13.33 months post-FAc implant (vs 3.24 months pre-FAc implant) was reported. Eleven eyes had an increased intraocular pressure of ≥10 mm Hg and 12 eyes had an increase to ≥25 mm Hg from baseline.ConclusionThese results further support the effectiveness and safety of FAc implant in previously treated patients with persistent or recurrent DMO in a real-world clinical practice.

scholarly journals Ocrelizumab initiation in patients with MS

2020 ◽  
Vol 7 (4) ◽  
pp. e719 ◽  
Author(s):  
Erik Ellwardt ◽  
Leoni Rolfes ◽  
Julia Klein ◽  
Katrin Pape ◽  
Tobias Ruck ◽  
...  
Keyword(s):  
Side Effects ◽  
Disease Course ◽  
Relapsing Remitting ◽  
Immune Therapies ◽  
Treatment Naïve ◽  
Previously Treated Patients ◽  
Pretreated Patients ◽  
Previously Treated ◽  
Class Iv

ObjectiveTo provide first real-world experience on patients with MS treated with the B cell–depleting antibody ocrelizumab.MethodsWe retrospectively collected data of patients who had received at least 1 treatment cycle (2 infusions) of ocrelizumab at 3 large neurology centers. Patients' characteristics including premedication, clinical disease course, and documented side effects were analyzed.ResultsWe could identify 210 patients (125 women, mean age ± SD, 42.1 ± 11.4 years) who had received ocrelizumab with a mean disease duration of 7.3 years and a median Expanded Disability Status Scale score of 3.75 (interquartile range 2.5–5.5; range 0–8). Twenty-six percent of these patients had a primary progressive MS (PPMS), whereas 74% had a relapsing-remitting (RRMS) or active secondary progressive (aSPMS) disease course. Twenty-four percent of all patients were treatment naive, whereas 76% had received immune therapies before. After ocrelizumab initiation (median follow-up was 200 days, range 30–1,674 days), 13% of patients with RRMS/aSPMS experienced a relapse (accounting for an annualized relapse rate of 0.17, 95% CI 0.10–0.24), and 5% of all patients with MS experienced a 12-week confirmed disability progression. Treatment was generally well tolerated, albeit only short-term side effects were recorded, including direct infusion-related reactions and mild infections.ConclusionsWe provide class IV evidence that treatment with ocrelizumab can stabilize naive and pretreated patients, indicating that ocrelizumab is an option following potent MS drugs such as natalizumab and fingolimod. Further studies are warranted to confirm these findings and to reveal safety concerns in the longer-term follow-up.Classification of evidenceThis study provides Class IV evidence that for patients with MS, ocrelizumab can stabilize both treatment-naive and previously treated patients.

scholarly journals Real-World Lab Data in Natalizumab Treated Multiple Sclerosis Patients Up to 6 Years Long-Term Follow Up

2018 ◽  
Vol 9 ◽  
Author(s):  
Maxi Kaufmann ◽  
Rocco Haase ◽  
Undine Proschmann ◽  
Tjalf Ziemssen ◽  
Katja Akgün
Keyword(s):  
Multiple Sclerosis ◽  
Real World ◽  
Long Term Follow Up ◽  
Multiple Sclerosis Patients

scholarly journals Three-year follow-up of treatment-naïve and previously treated patients with CLL and SLL receiving single-agent ibrutinib

Blood ◽  
2015 ◽  
Vol 125 (16) ◽  
pp. 2497-2506 ◽  
Author(s):  
John C. Byrd ◽  
Richard R. Furman ◽  
Steven E. Coutre ◽  
Jan A. Burger ◽  
Kristie A. Blum ◽  
...  
Keyword(s):  
Adverse Events ◽  
Single Agent ◽  
Extended Treatment ◽  
Key Points ◽  
Treatment Naïve ◽  
Previously Treated Patients ◽  
Previously Treated ◽  
Grade 3 ◽  
Over Time

Key Points Three-year follow-up of ibrutinib in CLL demonstrated continued activity with durable responses that improve in quality with extended treatment. Toxicity diminished over time with respect to grade ≥3 cytopenias, fatigue, infections, and adverse events leading to discontinuation.

scholarly journals Real-world outcomes following 12 months of intravitreal aflibercept monotherapy in patients with diabetic macular edema in France: results from the APOLLON study

2020 ◽  
Vol 258 (3) ◽  
pp. 521-528 ◽  
Author(s):  
Jean-François Korobelnik ◽  
Vincent Daien ◽  
Céline Faure ◽  
Ramin Tadayoni ◽  
Audrey Giocanti-Auregan ◽  
...  
Keyword(s):  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Treatment Start ◽  
Anti Vegf ◽  
Intravitreal Aflibercept ◽  
Treatment Naïve ◽  
Secondary Endpoints ◽  
Previously Treated Patients ◽  
Previously Treated ◽  
Endothelial Growth Factor

Abstract Purpose To report the effectiveness of intravitreal aflibercept (IVT-AFL) treatment for diabetic macular edema (DME) in French clinical practice. Methods APOLLON (NCT02924311) was a prospective, observational cohort study of patients with DME. Effectiveness was evaluated by change from baseline in best-corrected visual acuity (BCVA) at 12 months in treatment-naïve patients (i.e., had not received any anti-vascular endothelial growth factor [anti-VEGF] agent, laser, or steroid at IVT-AFL treatment start) and previously treated patients (i.e., previously treated with anti-VEGF agents other than IVT-AFL, laser, or steroids at IVT-AFL treatment start). Secondary endpoints included change in central retinal thickness (CRT) over 12 months, frequency of injections, and proportion of patients with safety events. Results Of the 147 patients followed for at least 12 months and included in the effectiveness analysis, 52.4% (n = 77) were treatment-naïve and 47.6% (n = 70) were previously treated. Mean (standard deviation [SD]) BCVA score at baseline was 62.7 (14.3) Early Treatment Diabetic Retinopathy Study (ETDRS) letters in treatment-naïve patients and 60.0 (13.7) ETDRS letters in previously treated patients. At month 12, mean (SD) change in BCVA was + 7.8 (12.3) letters in treatment-naïve patients and + 5.0 (11.3) letters in previously treated patients. Mean CRT decreased in both patient cohorts. The mean (SD) number of IVT-AFL injections at month 12 was 7.6 (2.5) for treatment-naïve patients and 7.6 (2.3) for previously treated patients. Of 388 patients included in the safety analysis, ocular treatment-emergent adverse events occurred in 54.1% (n = 210) of patients. Conclusion IVT-AFL treatment was associated with improvements in functional and anatomic outcomes in both treatment-naïve and previously treated patients with DME in France.

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