Vasculitis: Effects of Remission Maintenance
Description: Vasculitis: Effects of Remission Maintenance Therapies on Relapse and Side Effects: Patient Preferences (VERITAS) Lonnie Pyne1, Jennifer C. Rodrigues2, Kalen Larsen3, Gordon Guyatt1, Lehana Thabane1, Nader Khalidi1, Peter A. Merkel4,
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slide1. Vasculitis: Effects of Remission Maintenance Therapies on Relapse and Side Effects: Patient Preferences (VERITAS)
Lonnie Pyne1, Jennifer C. Rodrigues2, Kalen Larsen3, Gordon Guyatt1, Lehana Thabane1, Nader Khalidi1, Peter A. Merkel4, Michael Walsh1 for the Vasculitis Patient-Powered Research Network (VPPRN)*
McMaster University, 2. Humber River Hospital, 3. VPPN, 4. University of Pennsylvania
* The VPPRN is supported in part by the Vasculitis Foundation Introduction Methods Insert Footer or Copyright Information Here Printed by a.) Relapses are common in vasculitis and preventing relapses is a goal of treatment
It is unknown to what degree patients value relapse avoidance and how much risk they are willing to accept to avoid relapses
With patient partners we designed, piloted, and administered a survey called the Vasculitis: Effects of Remission maintenance Therapy on relapse and Side effects: patient preferences (VERITAS) Methods Scenarios presented an additional maintenance therapy resulting in varying relapse risk reduction and varying risk of adverse events
Baseline relapse risk was 30% over 5 years. The additional maintenance agent resulted in a 5, 10, or 15% relapse absolute risk reduction (ARR)
The maintenance agent also resulted in either a 0 or 5% absolute increase in the risk of adverse events (AEs)
Participants were randomized to the additional maintenance agent remaining unnamed or identified as prednisone
The distribution of minimally important difference (MID) in relapse risk (smallest ARR that the additional therapy was accepted) was determined for each respondent
Multivariable logistic regression models were used to calculate the effect of naming the therapy prednisone on the MID for relapse Results The majority of respondents accepted maintenance therapy with a 5% ARR in relapse in scenarios with (56.1%) and without (68.7%) an increase in AEs (figure 1)
Naming the therapy prednisone increased the benefit needed to accept therapy when no excess AEs were specified (38.5% of respondents had an MID >5% in prednisone scenarios as compared to 24.8% in unnamed therapy scenarios, p=0.002) but not in scenarios with excess AEs (49% of respondents had an MID >5% in prednisone scenarios as compared to 39.1% in unnamed therapy scenarios, p=0.11)
Presenting scenarios with excess AEs first increased the benefits required to accept additional therapy compared to when scenarios without excess AEs were presented first (42.3% of respondents had an MID >5% when excess AE scenarios were presented first compared to 21.2% when no excess AE scenarios were presented first, p<0.001) Figure 1 – Distribution of absolute risk reduction in relapse (MID) required to accept maintenance therapy in scenarios with an increase in adverse events (a), and without an increase in adverse events (b). Conclusions Most respondents considered absolute risk reduction in relapse of at least 5% to be sufficient to accept additional therapy
Less than 1/3 of respondents would reject an additional therapy with a relapse ARR of 15%
These results can be used to plan future trials and frame treatment effects for patients b.) a.)<br>
Lonnie Pyne1, Jennifer C. Rodrigues2, Kalen Larsen3, Gordon Guyatt1, Lehana Thabane1, Nader Khalidi1, Peter A. Merkel4, Michael Walsh1 for the Vasculitis Patient-Powered Research Network (VPPRN)*
McMaster University, 2. Humber River Hospital, 3. VPPN, 4. University of Pennsylvania
* The VPPRN is supported in part by the Vasculitis Foundation Introduction Methods Insert Footer or Copyright Information Here Printed by a.) Relapses are common in vasculitis and preventing relapses is a goal of treatment
It is unknown to what degree patients value relapse avoidance and how much risk they are willing to accept to avoid relapses
With patient partners we designed, piloted, and administered a survey called the Vasculitis: Effects of Remission maintenance Therapy on relapse and Side effects: patient preferences (VERITAS) Methods Scenarios presented an additional maintenance therapy resulting in varying relapse risk reduction and varying risk of adverse events
Baseline relapse risk was 30% over 5 years. The additional maintenance agent resulted in a 5, 10, or 15% relapse absolute risk reduction (ARR)
The maintenance agent also resulted in either a 0 or 5% absolute increase in the risk of adverse events (AEs)
Participants were randomized to the additional maintenance agent remaining unnamed or identified as prednisone
The distribution of minimally important difference (MID) in relapse risk (smallest ARR that the additional therapy was accepted) was determined for each respondent
Multivariable logistic regression models were used to calculate the effect of naming the therapy prednisone on the MID for relapse Results The majority of respondents accepted maintenance therapy with a 5% ARR in relapse in scenarios with (56.1%) and without (68.7%) an increase in AEs (figure 1)
Naming the therapy prednisone increased the benefit needed to accept therapy when no excess AEs were specified (38.5% of respondents had an MID >5% in prednisone scenarios as compared to 24.8% in unnamed therapy scenarios, p=0.002) but not in scenarios with excess AEs (49% of respondents had an MID >5% in prednisone scenarios as compared to 39.1% in unnamed therapy scenarios, p=0.11)
Presenting scenarios with excess AEs first increased the benefits required to accept additional therapy compared to when scenarios without excess AEs were presented first (42.3% of respondents had an MID >5% when excess AE scenarios were presented first compared to 21.2% when no excess AE scenarios were presented first, p<0.001) Figure 1 – Distribution of absolute risk reduction in relapse (MID) required to accept maintenance therapy in scenarios with an increase in adverse events (a), and without an increase in adverse events (b). Conclusions Most respondents considered absolute risk reduction in relapse of at least 5% to be sufficient to accept additional therapy
Less than 1/3 of respondents would reject an additional therapy with a relapse ARR of 15%
These results can be used to plan future trials and frame treatment effects for patients b.) a.)<br>