madman
Super Moderator
ABSTRACT
Background: It is currently unclear if men with Peyronie's Disease (PD) who achieve minimal benefits with the first 2 series of Collagenase Clostridium Histolyticum (CCH) injections should continue with additional injections.
Aim: To analyze curvature improvements from the final two series of CCH injections based on the amount of improvement during the first 2 series.
Methods: A prospective registry was analyzed of all men undergoing CCH injections for PD at a single institution. Men were included if they had completed a full 4 series (8 injections) of CCH and had baseline, interval (after 2 series), and/or final (after 4 series) curvature assessments available. Men were stratified into cohorts using baseline-to-interval assessments of ≤10° (or ≤20%) and >10° (or >20%), and improvements were compared using interval-to-final assessments.
Outcomes: The primary outcome was interval-to-final curvature improvements stratified by ≤10°/>10° or ≤20%/>20% improvements achieved during the baseline-to-interval period. Secondary outcomes included analyses of demographic and pathophysiologic variables to determine associations with significant improvements during the final 2 CCH series.
Results: A total of 296 PD men were identified as receiving at least one CCH injection, of whom 175 had baseline-to-interval, 84 interval-to-final, and 115 with baseline-to-final measurements. Mean age was 56.6, PD duration 28.6 months, baseline curvature 63.4°, hourglass deformity 36.2%, and calcification 20%. The mean overall curve improvement was -21.5° (33.1%). Among men who experienced ≤20% improvements after 2 series, the mean subsequent curvature change was -24.6% during the final two series (vs +4.3% of those with >20% initial improvement, P< .001), and they were 2.7x more likely to experience >20% subsequent curve improvements. Thirty-one percent of those who achieved >10° during the first 2 series experienced benefits during the final 2 series compared to 70% of men who had ≤10° improvement initially. No demographic or pathophysiological variables predicted the likelihood for improvements during the final 2 series of injections.
Clinical Implications: Men who fail to achieve significant benefits with 2 series of CCH injections may benefit from completing the final 2 series.
Strengths and Limitations: Strengths including a relatively large, prospective series. Limitations include a single-center, nonrandomization, nonblinded assessments, and restriction to men who completed eight injections.
Conclusions: In the current series, approximately 2/3 of men who fail to achieve >10° or 20% curve improvements with an initial 2 series of CCH injections achieved >10° or 20% improvements with the subsequent 2 series.
INTRODUCTION
Peyronie's Disease (PD) is a penile condition affecting 0.4- 13% of men between ages 40-70 and is characterized by fibrotic plaque formation in the tunica albuginea.1-6 Though surgery has historically been the gold-standard therapy for PD, intralesional injections have become a common conservative treatment option which results in curvature improvement without the need for surgery and with fewer long-term comorbidities in the majority of men. Particularly following approval of collagenase Clostridium histolyticum (CCH) by The Food and Drug Administration (FDA), treatment patterns have begun to favor injection therapies over surgery as first-line treatment for PD.7
Consistent with data from the 2 landmark, phase III, randomized controlled (IMPRESS) trials, the majority of post-FDA release data have further shown that CCH is an effective treatment for most men with PD, with a percentage of men failing to respond to therapy.8-12 A treatment cost comparison analysis performed by the Mayo Clinic in 2019 found that CCH reduced curvature by ≥20% in approximately 2/3 of cases.13 These numbers were supported by the largest, multi-institutional series performed to date, which involved 918 men and demonstrated success rates ranging from 63% to 69%.9 Although the majority of postrelease data report similar outcomes, one series of 45 men reported nonstatistically significant improvements in curvature (5° with primary and 4° with secondary), suggesting that injection technique and postinjection treatment protocols may contribute to overall success rates.14
Data from the above-mentioned trials have consistently shown that, on average, individuals receiving CCH are most likely to experience the greatest improvements after the first series of injections, with declining benefits after each subsequent series.8 However, given the fact that individuals will each respond differently, one key clinical question is how to council men who have failed to respond to the initial series of injections. Specifically, should men stop therapy or continue with additional injections if they have failed an initial set of injections? To address this question, we queried our cohort of men undergoing CCH injections to determine final outcomes of men, based on how they responded to the initial two series. We hypothesized that a man who failed to respond during the first two series would similarly not benefit from additional injections.
CONCLUSION
Data from the current study indicate that men who experienced minimal improvements (≤10° or ≤20%) after 2 series of CCH injections subsequently experienced ≥10° or ≥20% improvements with the final 2 series in roughly two-third of cases. In contrast, men who initially experience greater improvements were less likely to experience as significant changes with the final 2 series, although approximately one-third will go on to experience further benefits. These data are clinically important, as they may help to guide practicing clinicians on the important question as to whether or not to continue administering CCH injections to men who are initially non-responders.
Background: It is currently unclear if men with Peyronie's Disease (PD) who achieve minimal benefits with the first 2 series of Collagenase Clostridium Histolyticum (CCH) injections should continue with additional injections.
Aim: To analyze curvature improvements from the final two series of CCH injections based on the amount of improvement during the first 2 series.
Methods: A prospective registry was analyzed of all men undergoing CCH injections for PD at a single institution. Men were included if they had completed a full 4 series (8 injections) of CCH and had baseline, interval (after 2 series), and/or final (after 4 series) curvature assessments available. Men were stratified into cohorts using baseline-to-interval assessments of ≤10° (or ≤20%) and >10° (or >20%), and improvements were compared using interval-to-final assessments.
Outcomes: The primary outcome was interval-to-final curvature improvements stratified by ≤10°/>10° or ≤20%/>20% improvements achieved during the baseline-to-interval period. Secondary outcomes included analyses of demographic and pathophysiologic variables to determine associations with significant improvements during the final 2 CCH series.
Results: A total of 296 PD men were identified as receiving at least one CCH injection, of whom 175 had baseline-to-interval, 84 interval-to-final, and 115 with baseline-to-final measurements. Mean age was 56.6, PD duration 28.6 months, baseline curvature 63.4°, hourglass deformity 36.2%, and calcification 20%. The mean overall curve improvement was -21.5° (33.1%). Among men who experienced ≤20% improvements after 2 series, the mean subsequent curvature change was -24.6% during the final two series (vs +4.3% of those with >20% initial improvement, P< .001), and they were 2.7x more likely to experience >20% subsequent curve improvements. Thirty-one percent of those who achieved >10° during the first 2 series experienced benefits during the final 2 series compared to 70% of men who had ≤10° improvement initially. No demographic or pathophysiological variables predicted the likelihood for improvements during the final 2 series of injections.
Clinical Implications: Men who fail to achieve significant benefits with 2 series of CCH injections may benefit from completing the final 2 series.
Strengths and Limitations: Strengths including a relatively large, prospective series. Limitations include a single-center, nonrandomization, nonblinded assessments, and restriction to men who completed eight injections.
Conclusions: In the current series, approximately 2/3 of men who fail to achieve >10° or 20% curve improvements with an initial 2 series of CCH injections achieved >10° or 20% improvements with the subsequent 2 series.
INTRODUCTION
Peyronie's Disease (PD) is a penile condition affecting 0.4- 13% of men between ages 40-70 and is characterized by fibrotic plaque formation in the tunica albuginea.1-6 Though surgery has historically been the gold-standard therapy for PD, intralesional injections have become a common conservative treatment option which results in curvature improvement without the need for surgery and with fewer long-term comorbidities in the majority of men. Particularly following approval of collagenase Clostridium histolyticum (CCH) by The Food and Drug Administration (FDA), treatment patterns have begun to favor injection therapies over surgery as first-line treatment for PD.7
Consistent with data from the 2 landmark, phase III, randomized controlled (IMPRESS) trials, the majority of post-FDA release data have further shown that CCH is an effective treatment for most men with PD, with a percentage of men failing to respond to therapy.8-12 A treatment cost comparison analysis performed by the Mayo Clinic in 2019 found that CCH reduced curvature by ≥20% in approximately 2/3 of cases.13 These numbers were supported by the largest, multi-institutional series performed to date, which involved 918 men and demonstrated success rates ranging from 63% to 69%.9 Although the majority of postrelease data report similar outcomes, one series of 45 men reported nonstatistically significant improvements in curvature (5° with primary and 4° with secondary), suggesting that injection technique and postinjection treatment protocols may contribute to overall success rates.14
Data from the above-mentioned trials have consistently shown that, on average, individuals receiving CCH are most likely to experience the greatest improvements after the first series of injections, with declining benefits after each subsequent series.8 However, given the fact that individuals will each respond differently, one key clinical question is how to council men who have failed to respond to the initial series of injections. Specifically, should men stop therapy or continue with additional injections if they have failed an initial set of injections? To address this question, we queried our cohort of men undergoing CCH injections to determine final outcomes of men, based on how they responded to the initial two series. We hypothesized that a man who failed to respond during the first two series would similarly not benefit from additional injections.
CONCLUSION
Data from the current study indicate that men who experienced minimal improvements (≤10° or ≤20%) after 2 series of CCH injections subsequently experienced ≥10° or ≥20% improvements with the final 2 series in roughly two-third of cases. In contrast, men who initially experience greater improvements were less likely to experience as significant changes with the final 2 series, although approximately one-third will go on to experience further benefits. These data are clinically important, as they may help to guide practicing clinicians on the important question as to whether or not to continue administering CCH injections to men who are initially non-responders.
