scholarly journals Adherence to subcutaneous interferon beta-1a treatment using an electronic injection device: a prospective open-label Scandinavian noninterventional study (the ScanSmart study)

2018 ◽  
Vol Volume 12 ◽  
pp. 569-575 ◽  
Author(s):  
Elena Didenko Pedersen ◽  
Egon Stenager ◽  
JL Vadgaard ◽  
Michael Broksgaard Jensen ◽  
R Schmid ◽  
...  
Keyword(s):  
Interferon Beta ◽  
Injection Device ◽  
Open Label ◽  
Electronic Injection ◽  
Noninterventional Study

scholarly journals Patients transitioning from non-pegylated to pegylated interferon beta-1a have a low risk of new flu-like symptoms: ALLOW phase 3b trial results

2019 ◽  
Vol 5 (1) ◽  
pp. 205521731882214 ◽  
Author(s):  
Robert T Naismith ◽  
Barry Hendin ◽  
Sibyl Wray ◽  
DeRen Huang ◽  
Fiorenza Gaudenzi ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Interferon Beta ◽  
Pegylated Interferon ◽  
Symptom Duration ◽  
Open Label ◽  
Open Label Study ◽  
Management Guidance ◽  
Cumulative Duration ◽  
Multiple Sclerosis Patients ◽  
Relapsing Multiple Sclerosis

Background Flu-like symptoms are common adverse events associated with interferon beta relapsing multiple sclerosis therapies. Objectives To evaluate the incidence and severity of flu-like symptoms after transitioning from non-pegylated interferons to peginterferon beta-1a and assess flu-like symptom mitigation using naproxen. Methods ALLOW was a phase 3b open-label study in relapsing multiple sclerosis patients. Patients had received non-pegylated interferon for 4 or more months immediately before beginning a 4-week screening period. At baseline, patients switched to peginterferon beta-1a and were randomly assigned (1:1) to continue their current flu-like symptoms management regimen or start twice-daily naproxen 500 mg for 8 weeks. Patients then switched to their preferred regimen and were followed for 48 weeks in total. Results Of 201 patients, 89.6% did not experience new/worsening flu-like symptoms during their first 8 weeks on peginterferon beta-1a. Flu-like symptom severity remained low in current-regimen and naproxen patients, with no significant between-group differences. Median flu-like symptom duration per injection was 3.2 hours longer with peginterferon beta-1a versus prior interferon, but the 4-week cumulative duration was reduced 49–78%. No new safety signals were identified. Conclusion Most patients who switched from non-pegylated interferon to peginterferon beta-1a did not experience new/worsening flu-like symptoms. Flu-like symptom duration per injection increased, but the cumulative duration significantly decreased. These data may inform flu-like symptom management guidance.

Updated results of a prospective noninterventional study of everolimus after failure of the first VEGF-targeted therapy.

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 361-361
Author(s):  
Michael D. Staehler ◽  
Peter J. Goebell ◽  
Ulrich Kube ◽  
Manfred Kindler ◽  
Thomas Koepke ◽  
...  
Keyword(s):  
Targeted Therapy ◽  
Interim Analysis ◽  
Treatment Duration ◽  
Cell Cancer ◽  
Interventional Study ◽  
Open Label ◽  
Safety Population ◽  
Total Observation ◽  
Noninterventional Study ◽  
Observation Period

361 Background: Everolimus (EVE, Afinitor) is approved for the treatment of metastatic renal cell cancer (mRCC) after failure of VEGF-targeted therapy. The option to treat mRCC with six approved targeted agents has sparked debate on proper sequencing of these agents. However, data beyond clinical trials is limited. Here, we report prospective non-interventional data on EVE in routine use after failure of the first VEGF-targeted therapy. Methods: A prospective, single arm, open label, multi center non-interventional study for patients with mRCC was initiated in Germany in 08/2009 to determine effectiveness defined as time between first EVE intake until disease progression due to any cause (TTP) and treatment duration. Targeted enrollment is 400 patients. A first interim analysis was conducted 3 months after 100 patients had been enrolled and was presented previously (Bergmann et al., J Clin Oncol 29: 2011 [suppl; abstr 4552]). Here we present a second interim analysis to corroborate the results of the first interim analysis. Patients were analyzed 14 months after the first 100 patients had been enrolled. Results: 59 sites included 113 patients between August 2009 and July 2010. At the cut-off date of the first interim analysis (12 November 2011), these patients had been followed for a median of 116 days. The safety population consisted of 99 patients with documented EVE treatment. The median treatment duration had not yet been reached at the time of the first interim analysis. Median time to progression (TTP) was 9.7 months (95% CI: 6 months; n.d.). A total of 230 AEs were reported in 61% of patients including 18 SAEs in 12 patients (12%). These preliminary results are substantiated in this interim analysis with a total observation period of at least 14 months (cut-off date 30 September 2011). Updated data on effectiveness and safety of EVE will be presented. Conclusions: This non-interventional study on EVE in treatment of mRCC after prior failure of VEGF-targeted therapy provides first evidence on routine use of EVE. Further analysis of this ongoing study affords insight into effectiveness and safety of EVE in routine use after failure of the first VEGF-targeted therapy.

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