In Peyronie's disease patients, high levels of bother and distress are possible regardless of the degree of curvature, according to phase III data presented at the Sexual Medicine Society of North America (SMSNA)/International Society for Sexual Medicine (ISSM) joint annual meeting in Chicago.
In Peyronie’s disease patients, high levels of bother and distress are possible regardless of the degree of curvature, according to phase III data presented at the Sexual Medicine Society of North America (SMSNA)/International Society for Sexual Medicine (ISSM) joint annual meeting in Chicago.
The findings came from Auxilium Pharmaceuticals, Inc.’s phase III IMPRESS (The Investigation for Maximal Peyronie’s Reduction Efficacy and Safety Studies) trials that assessed collagenase clostridium histolyticum (XIAFLEX), an in-office biologic therapy for the potential treatment of Peyronie’s disease.
A baseline analysis from IMPRESS focused on the psychosocial impact on men with Peyronie’s disease; specifically, the level of disease bother and distress associated with Peyronie’s disease as related to the degree of penile curvature deformity. At baseline, results showed that all degrees of curvature deformity evaluated in the studies may be associated with high levels of bother and distress. Specifically, more than half (58%) of patients with lesser levels of curvature deformity (30 to 60 degrees) reported that they were "very bothered" or "extremely bothered" about their condition.
Additional results showed that 73% of patients with curvature deformity of 60 to 90 degrees were also "very bothered" or "extremely bothered" about their condition. A high level of patient-reported moderate to severe distress over Peyronie’s disease was also noted among subjects with curvature deformity of 30 to 60 or 60 to 90 degrees (80.5% and 90.5%, respectively).
"It has long been assumed that the less the penile curvature deformity, the less a patient would be bothered by the deformity, but this analysis shows that patients with any degrees of curvature (30 to 90 degrees) may experience high levels of bother and distress," said James Tursi, MD, of Auxilium. "This supports that measuring curvature alone would not capture the full impact of the disease and consideration of the psychosexual components should be an important aspect of managing and treating patients."
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