Duration of Treatment Effect of IncobotulinumtoxinA in Upper Limb Spasticity

2017 ◽  
Vol 98 (10) ◽  
pp. e55
Author(s):  
Michael Pellegrino ◽  
Petr Kanovsky ◽  
Michael Munin ◽  
Michael Althaus ◽  
Angelika Hanschmann ◽  
...  
Toxicon ◽  
2021 ◽  
Vol 190 ◽  
pp. S37
Author(s):  
Petr Kaňovský ◽  
Elie P. Elovic ◽  
Angelika Hanschmann ◽  
Irena Pulte ◽  
Michael Althaus ◽  
...  

Toxicon ◽  
2016 ◽  
Vol 123 ◽  
pp. S47
Author(s):  
Petr Kaňovský ◽  
Michael Althaus ◽  
Angelika Hanschmann ◽  
Irena Pulte

2021 ◽  
Vol 11 ◽  
Author(s):  
Petr Kaňovský ◽  
Elie P. Elovic ◽  
Angelika Hanschmann ◽  
Irena Pulte ◽  
Michael Althaus ◽  
...  

The efficacy and safety of incobotulinumtoxinA ≤400 U was demonstrated in subjects with post-stroke upper-limb spasticity in a randomized, double-blind Phase 3 study with an open-label extension (OLEX; EudraCT number 2005-003951-11, NCT00432666). We report a post-hoc analysis of the duration of the treatment effect. Subjects completing the placebo-controlled main period (single injection cycle with 12–20-week observation) entered the OLEX and received a maximum of five further treatments (maximum duration 69 weeks) with incobotulinumtoxinA ≤400 U at flexible intervals with a minimum duration of 12 weeks, based on clinical need. Intervals between two consecutive incobotulinumtoxinA injections, excluding treatment intervals prior to the end-of-study visit, were evaluated. Of 437 incobotulinumtoxinA treatment intervals, 415 received by 136 subjects were included in the post-hoc analysis. More than half (52.3%; 217/415) of all incobotulinumtoxinA reinjections were administered at Week ≥14, 31.1% (129/415) at Week ≥16, 19.0% (79/415) at Week ≥18, and 11.6% (48/415) at Week ≥20. The duration of effect may vary and can exceed 20 weeks or more, which was observed in at least one injection cycle in 29.4% (40/136) subjects over the course of their treatment. Data show that incobotulinumtoxinA retreatment for upper-limb spasticity may not be required at 12-week intervals and provides evidence for flexible treatment intervals beyond this time frame.


2019 ◽  
Vol 39 (4) ◽  
pp. 461-473 ◽  
Author(s):  
Bethan Copsey ◽  
James Buchanan ◽  
Raymond Fitzpatrick ◽  
Sarah E. Lamb ◽  
Susan J. Dutton ◽  
...  

Objective. This study examined whether duration of treatment effect should be considered in a benefit-risk assessment using a case study of osteoarthritis medications. Study Design and Setting. A discrete choice experiment was completed by 300 residents of the United Kingdom with hip and/or knee osteoarthritis. In 16 choice tasks, participants selected their preferred option from 2 medications. Medications were described in terms of effect on pain, stiffness, and function; duration of treatment effect; and risk of heart attack and stomach ulcer bleeding. The analysis used mixed-effects logistic regression. Results. Pain, disease severity, and duration of treatment effect had the greatest influence on medication preferences, whereas stiffness did not significantly affect medication choice. Participants were willing to accept an increase in the risk of heart attack of 2.6% (95% confidence interval: 2.0% to 3.2%) to increase the duration of treatment effect from 1 month to 12 months. Reducing pain from moderate to mild was valued the same as increasing duration of effect from 1 month to 3 months; both were seen as equivalent to an absolute reduction of 1.2% in the risk of heart attack in the next year. Subgroup analysis suggested disease severity influenced patient preferences. Conclusions. Along with treatment benefits and risks, the results suggest that duration of treatment effect is an important factor in the medication choices of people with osteoarthritis. This could have implications for the design and interpretation of clinical trials, for example, incorporating longer-term surveillance of trial participants and accounting for duration of treatment effect in risk-benefit assessments. Future research is needed to assess whether these findings are generalizable to other samples, disease areas, and levels of duration of effect.


Sign in / Sign up

Export Citation Format

Share Document