ACKNOWLEDGEMENTS Study funded by Galderma Research & Development, SNC, and editorial/poster support provided by Galderma Laboratories, L.P. RESULTS • Mean percent reduction in inflammatory lesions between baseline and end of treatment was 14% better in “clear” subjects than “almost clear” subjects, with a reduction of 98.5% lesions vs. 84.5% (P < .001; Figure 1).1 • Between baseline and the end of treatment more “clear” subjects reported “excellent” improvement than “almost clear” subjects (76.8% vs. 41.8%; P < .001; Figure 2).1 • Better mean improvements were observed for the “clear” subjects in all 6 of the domains of the DLQI (Figure 3). • More “clear” subjects than “almost clear” subjects had a final DLQI score of 0-1 (84% vs. 66%; P < .001). • More “clear” subjects than “almost clear” subjects had (minimal clinically important difference) MCID (≥ 4 points change) in DLQI score (59% vs. 44%; P < .001). • Median time to relapse was: - 85 days (3 months) for “almost clear” subjects - More than 252 days (8 months) for “clear” subjects (Figure 4) • Relapse was delayed by more than 5 months for “clear” subjects compared to “almost clear” subjects (P < .001; Figure 5). INTRODUCTION • Rosacea treatment “Success” is defined on the Investigator Global Assessment (IGA) scale (0 [clear] through 4 [Severe]) as 0 or 1 (“clear” or “almost clear”) - This definition is used in clinical trials, by regulatory bodies, and by payers and physicians • Is it clinically meaningful to be “clear” vs “almost clear”? - What impact is there (if any) on the health related quality of life of rosacea patients? - What impact is there (if any) on the time to relapse? ACHIEVING AN ENDPOINT OF COMPLETELY CLEAR OF INFLAMMATORY LESIONS AND ERYTHEMA AFTER TREATMENT OF ROSACEA PROVIDES MULTIPLE POSITIVE PATIENT OUTCOMES: A POOLED ANALYSIS Guy Webster, MD1, Martin Schaller, MD2, Jerry Tan, MD3, Mark Jackson, MD4; Nabil Kerrouche, MSc5; Gregor Schafer, MD8 1Thomas Jefferson University, Philadelphia, Pennsylvania; 2Tubingen University Hospital, Tubingen, Germany; 3University of Western Ontario, London, Ontario and Windsor Clinical Research Inc, Windsor, Ontario, Canada; 4University of Louisville, Kentucky, USA; 5Galderma R&D, Sophia Antipolis, France; 6Galderma International, Paris, France SOO.P-RD10412-01 SUMMARY • These results emphasize that achieving an endpoint of IGA 0 (“clear”) in rosacea may provide multiple patient benefits and a significantly prolonged time before relapse • Achieving a treatment outcome of “clear” provides - Better patient appreciation of rosacea improvement · 35% more subjects reported ‘excellent improvement’ - Better improvement in quality of life, as measured by DLQI - A longer time to relapse · ≥ 5 months relapse-free time REFERENCES 1. Webster G, Schaller M, Tan J, et al. Defining treatment success in rosacea as ‘clear’ may provide multiple patient benefits: results of a pooled analysis. J Dermatolog Treat. 2017;28(5):469-474. METHODS Study Design • Objectives - To evaluate whether, after successful treatment, “clear” subjects had better outcomes than “almost clear” subjects • Methods - Pooled analysis of 1366 rosacea subjects from 4 randomized controlled trials with IGA assessments before and after treatment (ivermectin, metronidazole, or vehicle) • Assessments - Dermatology Life Quality Index (DLQI) questionnaire - Subject assessment of rosacea improvement - Time to relapse - Relapse defined as an IGA score of 2 (‘mild’) after a successful 16-week treatment period (IGA 0/1) 0 2 4 6 8 10 Clear (n = 270) Almost Clear (n = 487) 3 > 8 Figure 4. Median Time to Relapse (Months) Figure 5. Median Time to Relapse (Months) M ea n Pe rce nt R ed uc tio n in In fla m m at or y L es io n Co un t P < .001 IGA 0 (n = 341) IGA 1 (n = 1025) 98.5 84.5 50 60 70 80 90 10 0 Pe rce nt o f S ub je cts 76.8 20.3 2.3 0.7 41.8 44.6 11.8 1.7 0 10 20 30 40 50 60 70 80 90 1: Excellent Improvement 2: Good Improvement 3: Moderate Improvement 4: No Improvement IGA 0 (n = 306) IGA 1 (n = 878) P < .001 Figure 1. Better Improvement of Rosacea Figure 2. Better Patient Appreciation Table 1. Data From 4 Previous Randomized Controlled Trials Were Included in This Analysis Study Interventions DLQI Subject assessment of rosacea improvement Time to relapse SPR.40027 Dose range study IVM 0.1% QD, 0.3% QD, 1% QD, 1% BID and vehicle 12-Week treatment X – – SPR.18170 IVM 1% vs. Vehicle 12 weeks X X – SPR.18171 IVM 1% vs. Vehicle 12 weeks X X – SPR.40173 IVM 1% vs. Metro 0.75% 16 weeks (36-week follow-up) X X X Pe rce nt o f S ub je cts IGA 0 (n = 341) IGA 1 (n =1003) 16.1 84.2 58.7 16.9 66.0 44.3 0 10 20 30 40 50 60 70 80 90 100 DLQI Score 0 - 1 Baseline DLQI Score 0 - 1 End of Treatment MCID ≥ 4 End of Treatm ent P < .001 P < .001 • DLQI Scores: - 0 - 1 = No effect at all on the patient’s life - 2 - 5 = A small effect on the patient’s life - 6 - 10 = A moderate effect on the patient’s life - 11 - 20 = A very large effect on the patient’s life - 21 - 30 = An extremely large effect on the patient’s life Figure 3. Better Improvement in QoL Pe rce nt o f S ub je cts R em ai ni ng W ith ou t R el ap se 0 10 20 23 30 40 50 54 60 70 80 90 100 Time in Days IGA at the end of the treatement period Clear Almost Clear Median time to relapse “clear’ subjects: >252 days 0 14 28 42 56 70 84 96 112 126 140 154 168 182 196 210 224 238 252 Median time to relapse “almost clear’ subjects: 85 days P < .0001 Figure 5. Representative Photographs (10355-108-028) IGA Score: 3 2 1 0 FC17PosterGaldermaWebsterAchievingCompleteyClearLesions.pdf