1L NER1006 IMPROVES HIGH-QUALITY COLON CLEANSING VERSUS STANDARD BOWEL PREPARATIONS: POST HOC ANALYSIS OF PHASE 3 CLINICAL TRIALS USING REAL-WORLD CLEANSING ASSESSMENT BY SITE ENDOSCOPISTS

Aims:

Colonoscopy requires bowel cleansing; high-quality cleansing facilitates lesion detection. NER1006 is a 1L polyethylene glycol (PEG) bowel preparation. This post hoc analysis of three randomised trials investigated cleansing efficacy assessed, as in clinical practice, by site endoscopists.

Methods:

Patients received either a 2-day evening/morning regimen of NER1006 (N2D), 2L PEG+ascorbate (2LPEG), or oral sulfate solution (OSS); or day-before NER1006 (NDB) or sodium picosulfate plus magnesium citrate (SPMC). Morning-only NER1006 (N1D) dosing was also evaluated. Cleansing was assessed by treatment-blinded site endoscopists using the Harefield Cleansing Scale (HCS). This analysis included only patients with self-reported 100% treatment adherence. Overall cleansing success (HCS grade A or B), overall high-quality cleansing success (HCS grade A), and the proportion of high-quality segments (HCS 3 – 4) per treatment population were analysed.

Results:

Among 1985 randomised patients, 1367 were included (Table). Overall cleansing success was higher with N2D than 2LPEG (97.5% vs. 93.0%) and more patients had overall high-quality cleansing with N2D and N1D than 2LPEG (72.1% and 68.4% vs. 56.0%). N2D delivered more overall high-quality cleansing than OSS (77.3% vs. 69.8%). Overall cleansing success was higher with NDB than SPMC (74.5% vs. 62.9%) and more patients achieved HCS Grade A with NDB than SPMC (29.0% vs. 12.0%). More high-quality segments were demonstrated with N2D and N1D versus 2LPEG (87.1% and 84.4% vs. 76.3%), with N2D versus OSS (89.5% vs. 84.4%) and with NDB than SPMC (60.3% vs. 47.0%).

Tab. 1:

High-quality colon cleansing as assessed by site endoscopists in patients with self-reported 100% treatment adherence

Cleansing success	N2D vs. 2LPEG	N1D vs. 2LPEG	N2D vs. OSS	NDB vs. SPMC
Sample size: NER1006 vs. comparator, N	204 vs. 200	193 vs. 200	225 vs. 225	145 vs. 175
Overall cleansing success HCS Grades A+B, n/N (%); P-value	199/204 (97.5) vs. 186/200 (93.0) P = 0.016	180/193 (93.3) vs. 186/200 (93.0) P = 0.459	211/225 (93.8) vs. 210/225 (93.3) P = 0.424	108/145 (74.5) vs. 110/175 (62.9) P = 0.012
Overall high-quality cleansing success HCS Grade A, n/N (%); P-value	147/204 (72.1) vs. 112/200 (56.0) P < 0.001	132/193 (68.4) vs. 112/200 (56.0) P = 0.006	174/225 (77.3) vs. 157/225 (69.8) P = 0.035	42/145 (29.0) vs. 21/175 (12.0) P < 0.001
High-quality segments HCS 3 – 4, n/N (%); P-value	888/1020 (87.1) vs. 763/1000 (76.3) P < 0.001	814/965 (84.4) vs. 763/1000 (76.3) P < 0.001	1007/1125 (89.5) vs. 950/1125 (84.4) P < 0.001	437/725 (60.3) vs. 411/875 (47.0) P < 0.001

Conclusions:

When assessed by site-endoscopists NER1006 (PLENVU) delivers greater high-quality, HCS grade A, cleansing than 2LPEG, OSS, or SPMC.