patients who had both a penile curvature deformity

measurement and a PDQ response at baseline and at least

one subsequent time point after the

rst injection of CCH.

The mITT population appropriately excluded patients who

were not sexually active within 3 months of baseline

assessment. These patients were deemed ineligible to

complete the PDQ to help ensure the accuracy of patient

recall.

The subgroup analyses examined change in penile curvature

deformity and PDQ PD symptom bother scores from baseline

to week 52, using the last observation carried forward

approach for patients who did not have an evaluation at week

52. Within each subgroup, the CCH-treated group was

compared with placebo using

ANOVA

with a factor for

treatment group and either percent change in curvature

deformity or change from baseline in symptom bother score.

Results

The full demographic characteristics of the present study

population are reported by Gelbard et al. [20]. IMPRESS I

and II each included 418 randomized participants (IMPRESS

278 to CCH and

140 to placebo; IMPRESS II,

277 to CCH and

141 to placebo). The mITT

population for IMPRESS I was 303 (

199 for CCH and

104 for placebo), and the mITT population for

IMPRESS II was 309 (

202 for CCH and

107 for

placebo).

Baseline Penile Curvature Deformity

Results for the co-primary endpoints in patients with either

–

or 61

–

baseline penile curvature are shown in

Fig. 1. A total of 492 patients had a baseline penile curvature

of 30

–

(

318 for CCH and

174 for placebo), and

120 patients had a baseline penile curvature of 61

–

(

83 for CCH and

37 for placebo).

Signi

cantly greater improvements were observed in the CCH

treatment groups compared with the placebo groups in

percent change in penile curvature deformity for both the

–

curvature group (14.8

decrease for CCH, 7.6

for

placebo, a 33.8 vs 17.1% reduction, respectively;

0.001)

and the 61

–

curvature group (25.3

decrease for CCH,

17.0

for placebo, a 35.0 vs 23.3% reduction, respectively;

0.008). Signi

cantly greater improvement in the PD

symptom bother domain score was observed in the 30

–

group between the CCH treatment and placebo groups

(

0.004). In the 61

–

group, the difference between

CCH treatment and placebo approached but did not reach

statistical signi

cance (

0.071).

Duration of Disease at Baseline

Table 1 is a summary of co-primary endpoint results for

patients with a PD duration of 1

–

2 years,

2to

≤

4 years, or

4 years. At baseline, 201 patients had a duration of PD of

–

2 years, 212 had a duration of

2to

≤

4 years, and 199 had

a duration of

4 years.

Signi

cant improvements in mean percent penile curvature

deformity were observed in CCH-treated patients compared

with placebo in the

2to

≤

4-years group (

0.001), and the

4-years group (

0.001), although not in the 1

–

2-years

group (

0.28). For PD symptom bother, signi

cant

improvement was observed in CCH-treated patients

compared with placebo in the

4-years group (

0.01),

although not in the 1

–

2-years group (

0.14) or the

2to

≤

4-years group (

0.07).

30° to 60°

60° to 90°

Mean percent change in penile curvature

CCH

Placebo

CCH

Placebo

= 83

= 37

0.5

1.5

2.5

3.5

30° to 60°

60° to 90°

Change in PD symptom bother score

= 0.004

= 0.071

< 0.001

= 0.008

= 318

= 174

=318

= 174

= 83

= 37

Fig. 1

Change in (

) penile curvature and (

) Peyronie

’

s disease symptom bother from baseline to week 52 (last observation carried forward) by

baseline penile curvature. Bold text indicates statistical signi

cance. CCH, collagenase

Clostridium histolyticum

652

Lipshultz

et al.