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1 Supplementary Appendix This appendix has been provided by the authors to give readers additional information about their work. Supplement to: Lebwohl M, Swanson N, Anderson LL, Melgaard A, Xu Z, Berman B. Ingenol mebutate gel for actinic keratosis. N Engl J Med 2012;366:
2 Ingenol Mebutate Gel for Actinic Keratosis Online Supplement Mark Lebwohl, M.D., Neil Swanson, M.D., Lawrence L. Anderson, M.D., F.A.C.P., Anita Melgaard, M.Sc. Stat., Zhenyi Xu, M.D., and Brian Berman, M.D., Ph.D. TABLE OF CONTENTS Appendix A: Investigator List 3 Appendix B: Individual Study Data for the Four Pivotal Ingenol Mebutate Gel Trials 4 Table 1. Complete Clearance Rate of Actinic Keratosis (AK) Lesions at Day 57 Overall and by Anatomical Location: Intent-to-Treat Population. PEP /Trunk and Extremities. 4 Table 2. Partial Clearance Rate of AK Lesions at Day 57 Overall and by Anatomical Location: Intent-to-Treat Population. PEP /Trunk and Extremities. 5 Table 3. Percent Reduction From Baseline in AK Lesion Count at Day 57 Overall and by Anatomical Location: Intent-to-Treat Population. PEP /Trunk and Extremities. 6 Table 4. Composite Local Skin Response Score and Change From Baseline (mean ± SD) by Visit: Safety Population. PEP / Trunk and Extremities. 7 Table 5. Complete Clearance Rate of AK Lesions at Day 57 Overall and by Anatomical Location: Intent-to-Treat Population. PEP /Face and Scalp. 8 Table 6. Partial Clearance Rate of AK Lesions at Day 57 Overall and by Anatomical Location: Intent-to-Treat Population. PEP /Face and Scalp. 9 Table 7. Percent Change From Baseline in AK Lesion Count at Day 57 Overall and by Anatomical Location: Intent-to-Treat Population. PEP /Face and Scalp. 10 Table 8. Composite Local Skin Response Score and Change From Baseline by Visit: Safety Population. PEP /Face and Scalp. 11 Table 9. Complete Clearance Rate of AK Lesions at Day 57 Overall and by Anatomical Location: Intent-to-Treat Population. PEP /Face and Scalp. 12 Table 10. Partial Clearance Rate of AK Lesions at Day 57 Overall and by Anatomical Location: Intent-to-Treat Population. PEP /Face and Scalp. 13 1
3 Table 11. Percent Change From Baseline in AK Lesion Count at Day 57 Overall and by Anatomical Location: Intent-to-Treat Population. PEP /Face and Scalp. 14 Table 12. Composite Local Skin Response Score and Change From Baseline by Visit: Safety Population. PEP /Face and Scalp. 15 Table 13. Complete Clearance Rate of AK Lesions at Day 57 Overall and by Anatomical Location: Intent-to-Treat Population. PEP /Trunk and Extremities. 16 Table 14. Partial Clearance Rate of AK Lesions at Day 57 Overall and by Anatomical Location: Intent-to-Treat Population. PEP /Trunk and Extremities. 17 Table 15. Percent Reduction From Baseline in AK Lesion Count at Day 57 Overall and by Anatomical Location: Intent-to-Treat Population. PEP / Trunk and Extremities. 18 Table 16. Composite Local Skin Response Score and Change From Baseline by Visit: Safety Population. PEP /Trunk and Extremities. 19 Appendix C: Additional Data From Pooled Pivotal Trials 20 Table 1. Demographics and Baseline Disease Characteristics, Intent-to-Treat Population. 20 Figure 1. Enrollment and Disposition of Patients With Face or Scalp Lesions. *One patient who was randomized to ingenol mebutate gel received vehicle gel due to the incorrect study kit dispensed at site and was included in vehicle group for safety analyses. 23 Figure 2. Enrollment and Disposition of Patients With Trunk or Extremity Lesions. *One patient was randomized to the ingenol mebutate gel 0.05% group but actually received vehicle treatment and, therefore, was included in the vehicle group for all safety analyses. Likewise, one patient was randomized to the vehicle group but actually received ingenol mebutate gel 0.05% and, therefore, was included in the ingenol mebutate gel 0.05% group for all safety analyses. 24 Table 2. Summary of Treatment-Emergent Adverse Events With an Incidence of 1% in Any Treatment Group: Safety Population. 25 Table 3. Summary of Treatment-Emergent Serious Adverse Events. 27 2
4 Appendix A: Investigator List The full list of investigators is as follows: Study PEP : James Bernard, M.D., Michael Freeman, M.B.B.S. (Qld), F.R.A.C.G.P., F.A.C.D., Scott Guenther, M.D., Karen S. Harkaway, M.D., Terry M. Jones, M.D., Mark R. Ling, M.D., Ph.D., Keith Loven, M.D., Robert T. Matheson, M.D., Andrew Racette, M.D., George J. Schmieder, D.O., Michael Schneider, M.D., James A. Solomon, M.D., Ph.D., Linda Stein-Gold, M.D., Neil Swanson, M.D., James Swinehart, M.D., Ernest Tan, M.B.B.S., F.A.C.D., Eduardo Tschen, M.D., John Tu, M.D., and Jonathan Weiss, M.D. Study PEP : Lawrence L. Anderson, M.D., Brian Berman, M.D., Ph.D., Marcus A. Conant, M.D., Kenneth W. Dawes, M.D., Scott Glazer, M.D., Kenneth Gross, M.D., Tiffani K. Hamilton, M.D., Iltefat Hamzavi, M.D., David H. Horowitz, M.D., Terry M. Jones, M.D., Steven E. Kempers, M.D., Jonette Keri, M.D., Ph.D., Mark Ling, M.D., Adnan Nasir, M.D., Ph.D., David M. Pariser, M.D., Robert Rosen, M.B.B.S., M.Med., Joseph A. Samady, M.D., Stephen Shumack, M.B.B.S., Howard Sofen, M.D., Leonard J. Swinyer, M.D., Artis P. Truett III, M.D., and Stephen Tyring, M.D. Study PEP : Brian Berman, M.D., Ph.D., Suzanne Bruce, M.D., Michael Bukhalo, M.D., Sunil S. Dhawan, M.D., Michael Freeman, M.B.B.S. (Qld), Scott Guenthner, M.D., C. William Hanke, M.D., Karl G. Heine, M.D., Michael Jarratt, M.D., Jonathan Kantor, M.D., Mark Lebwohl, M.D., Mark Lee, M.D., Ellen Marmur, M.D., Robert Matheson, M.D., Girish Munavalli, M.D., Joel Schlessinger, M.D., Lynda Spelman, M.B.B.S., Dow Stough, M.D., Naji Tawfik, M.D., Eduardo Tschen, M.D., John Tu, M.D., William P. Werschler, M.D., and David Wilson, M.D. Study PEP : Lawrence Anderson, M.D., F.A.C.P., Suzanne Bruce, M.D., Michael Bukhalo, M.D., Steven Davis, M.D., Kenneth W. Dawes, M.D., Scott Glazer, M.D., Kenneth Gross, M.D., Tiffani Hamilton, M.D., Karl G. Heine, M.D., Michael Jarratt, M.D., Jeffrey K. Moore, M.D., David M. Pariser, M.D., Joel Schlessinger, M.D., Pranav Sheth, M.D., Dow Stough, M.D., Leonard Swinyer, M.D., F.A.A.D., C.P.I., and David Wilson, M.D. 3
5 Appendix B: Individual Study Data for the Four Pivotal Ingenol Mebutate Gel Trials Table 1. Complete Clearance Rate of Actinic Keratosis (AK) Lesions at Day 57 Overall and by Anatomical Location: Intent-to-Treat Population. PEP /Trunk and Extremities. 4
6 Table 2. Partial Clearance Rate of AK Lesions at Day 57 Overall and by Anatomical Location: Intent-to-Treat Population. PEP /Trunk and Extremities. 5
7 Table 3. Percent Reduction From Baseline in AK Lesion Count at Day 57 Overall and by Anatomical Location: Intent-to-Treat Population. PEP /Trunk and Extremities. 6
8 Table 4. Composite Local Skin Response Score and Change From Baseline (mean ± SD) by Visit: Safety Population. PEP /Trunk and Extremities. 7
9 Table 5. Complete Clearance Rate of AK Lesions at Day 57 Overall and by Anatomical Location: Intent-to-Treat Population. PEP /Face and Scalp. 8
10 Table 6. Partial Clearance Rate of AK Lesions at Day 57 Overall and by Anatomical Location: Intent-to-Treat Population. PEP /Face and Scalp. 9
11 Table 7. Percent Change From Baseline in AK Lesion Count at Day 57 Overall and by Anatomical Location: Intent-to-Treat Population. PEP /Face and Scalp. 10
12 Table 8. Composite Local Skin Response Score and Change From Baseline by Visit: Safety Population. PEP /Face and Scalp. 11
13 Table 9. Complete Clearance Rate of AK Lesions at Day 57 Overall and by Anatomical Location: Intent-to-Treat Population. PEP /Face and Scalp. 12
14 Table 10. Partial Clearance Rate of AK Lesions at Day 57 Overall and by Anatomical Location: Intent-to-Treat Population. PEP /Face and Scalp. 13
15 Table 11. Percent Change From Baseline in AK Lesion Count at Day 57 Overall and by Anatomical Location: Intent-to-Treat Population. PEP /Face and Scalp. 14
16 Table 12. Composite Local Skin Response Score and Change From Baseline by Visit: Safety Population. PEP /Face and Scalp. 15
17 Table 13. Complete Clearance Rate of AK Lesions at Day 57 Overall and by Anatomical Location: Intent-to-Treat Population. PEP /Trunk and Extremities. 16
18 Table 14. Partial Clearance Rate of AK Lesions at Day 57 Overall and by Anatomical Location: Intent-to-Treat Population. PEP /Trunk and Extremities. 17
19 Table 15. Percent Reduction From Baseline in AK Lesion Count at Day 57 Overall and by Anatomical Location: Intent-to-Treat Population. PEP /Trunk and Extremities. 18
20 Table 16. Composite Local Skin Response Score and Change From Baseline by Visit: Safety Population. PEP /Trunk and Extremities. 19
21 Appendix C Appendix C: Additional Data From Pooled Pivotal Trials Table 1. Demographics and Baseline Disease Characteristics, Intent-to-Treat Population. Face or Scalp Trunk or Extremities Ingenol mebutate Ingenol mebutate gel Vehicle gel gel Vehicle gel 0.015% 0.05% Parameter (N=277) (N=270) (N=226) (N=232) Geographic region (n [%]) United States 256 (92.4) 250 (92.6) 210 ( 92.9) 219 ( 94.4) Australia 21 (7.6) 20 (7.4) 16 ( 7.1) 13 ( 5.6) Age (years) n Mean (SD) 64.2 (10.8) 64.0 (10.1) 66.4 (10.4) 66.0 (10.3) Minimum, Maximum Age categories (years) (n [%]) <65 years 144 (52.0) 140 (51.9) 94 ( 41.6) 100 ( 43.1) years 83 (30.0) 88 (32.6) 84 ( 37.2) 85 ( 36.6) >75 years 50 (18.1) 42 (15.6) 48 ( 21.2) 47 ( 20.3) Sex (n [%]) Male 233 (84.1) 232 (85.9) 145 ( 64.2) 141 ( 60.8) Female 44 (15.9) 38 (14.1) 81 ( 35.8) 91 ( 39.2) 20
22 Appendix C Race (n [%]) White 277 (100) 270 (100) 226 (100) 232 (100) Ethnicity (n [%]) Non-Hispanic 276 (99.6) 267 (98.9) 223 (98.7) 230 (99.1) Hispanic 1 (0.4) 3 (1.1) 3 (1.3) 2 (0.9) Anatomical location Face 220 (79.4) 220 (81.5) 0 0 Scalp 57 (20.6) 50 (18.5) 0 0 Arm (62.8) 149 (64.2) Back of hand (23.9) 56 (24.1) Chest (6.2) 11 (4.7) Leg (4.0) 10 (4.3) Back (1.8) 3 (1.3) Shoulder (1.3) 3 (1.3) Fitzpatrick skin type I 51 (18.4) 34 (12.6) 52 (23.0) 55 (23.7) II 123 (44.4) 112 (41.5) 105 (46.5) 118 (50.9) III 84 (30.3) 111 (41.1) 52 (23.0) 48 (20.7) IV 19 (6.9) 13 (4.8) 15 (6.6) 11 ( 4.7) V (0.9) 0 Baseline lesion count 4 48 (17.3) 57 (21.1) 67 (29.6) 62 (26.7) 5 75 (27.1) 79 (29.3) 62 (27.4) 61 (26.3) 6 56 (20.2) 64 (23.7) 49 (21.7) 52 (22.4) 7 54 (19.5) 36 (13.3) 23 (10.2) 29 (12.5) 8 44 (15.9) 34 (12.6) 23 (10.2) 28 (12.1) 9* ( 0.9) 0 Skin cancer history 126 (45.5) 120 (44.4) 121 (53.5) 121 (52.2) 21
23 Appendix C Prior treatment Cryotherapy 224 (80.9) 227 (84.1) 170 (75.2) 178 (76.7) 5-Fluorouracil 55 (19.9) 52 (19.3) 50 (22.1) 56 (24.1) Imiquimod 25 (9.0) 31 (11.5) 21 ( 9.3) 32 (13.8) *Inclusion criteria specified that patients have 4 to 8 AK lesions within the treatment area. 22
24 Appendix C Figure 1. Enrollment and Disposition of Patients With Face or Scalp Lesions. *One patient who was randomized to ingenol mebutate gel received vehicle gel due to the incorrect study kit dispensed at site and was included in vehicle group for safety analyses. Percentage completed was based on the number randomized (n=270). 23
25 Appendix C Figure 2. Enrollment and Disposition of Patients With Trunk or Extremity Lesions. *One patient was randomized to the ingenol mebutate gel 0.05% group but actually received vehicle treatment and, therefore, was included in the vehicle group for all safety analyses. Likewise, one patient was randomized to the vehicle group but actually received ingenol mebutate gel 0.05% and, therefore, was included in the ingenol mebutate gel 0.05% group for all safety analyses. 24
26 Appendix C Table 2. Summary of Treatment-Emergent Adverse Events With an Incidence of 1% in Any Treatment Group: Safety Population. Ingenol Mebutate Gel Face or Scalp Trunk or Extremities Ingenol Mebutate Gel System Organ Class 0.015% Vehicle Gel 0.05% Vehicle Gel Preferred Term (N = 274) (N = 271) (N = 225) (N = 232) Any AE all systems 102 (37.2%) 60 (22.1%) 75 (33.3%) 63 (27.2%) General disorders and administrationsite conditions 52 (19.0%) 7 (2.6%) 27 (12.0%) 6 (2.6%) Application site Pruritus 22 (8.0%) 3 (1.1%) 19 (8.4%) 0 (0.0%) Pain 38 (13.9%) 1 (0.4%) 5 (2.2%) 0 (0.0%) Irritation 5 (1.8%) 0 (0.0%) 8 (3.6%) 1 (0.4%) Infections and infestations 20 (7.3%) 12 (4.4%) 15 (6.7%) 14 (6.0%) Application-site infection 7 (2.6%) 0 (0.0%) 0 (0.0%) 1 (0.4%) Nasopharyngitis 0 (0.0%) 1 (0.4%) 4 (1.8%) 2 (0.9%) Upper respiratory tract infection 0 (0.0%) 0 (0.0%) 3 (1.3%) 4 (1.7%) Skin and subcutaneous tissue disorders 11 (4.0%) 3 (1.1%) 10 (4.4%) 7 (3.0%) Periorbital edema 7 (2.6%) 0 (0.0%) 0 (0.0%) 0 (0.0%) Actinic keratosis 0 (0.0%) 0 (0.0%) 1 (0.4%) 3 (1.3%) Injury, poisoning, and procedural complications 10 (3.6%) 16 (5.9%) 8 (3.6%) 3 (1.3%) Back injury 3 (1.1%) 0 (0.0%) 0 (0.0%) 0 (0.0%) Contusion 1 (0.4%) 5 (1.8%) 1 (0.4%) 1 (0.4%) Neoplasms benign, malignant, and 4 (1.5%) 3 (1.1%) 7 (3.1%) 10 (4.3%) 25
27 Appendix C unspecified (including cysts and polyps) Basal cell carcinoma 3 (1.1%) 1 (0.4%) 3 (1.3%) 4 (1.7%) Squamous cell carcinoma 0 (0.0%) 0 (0.0%) 1 (0.4%) 3 (1.3%) Nervous system disorders 11 (4.0%) 6 (2.2%) 2 (0.9%) 2 (0.9%) Headache 6 (2.2%) 3 (1.1%) 1 (0.4%) 2 (0.9%) Musculoskeletal and connective tissue disorders 4 (1.5%) 7 (2.6%) 6 (2.7%) 3 (1.3%) Back pain 0 (0.0%) 3 (1.1%) 0 (0.0%) 0 (0.0%) Investigations 5 (1.8%) 8 (3.0%) 10 (4.4%) 9 (3.9%) Electrocardiogram T wave biphasic 0 (0.0%) 0 (0.0%) 0 (0.0%) 3 (1.3%) Electrocardiogram QT prolonged 3 (1.1%) 3 (1.1%) 0 (0.0%) 0 (0.0%) Gastrointestinal disorders 5 (1.8%) 1 (0.4%) 3 (1.3%) 1 (0.4%) Respiratory, thoracic, and mediastinal disorders 4 (1.5%) 3 (1.1%) 5 (2.2%) 6 (2.6%) Cardiac disorders 2 (0.7%) 7 (2.6%) 9 (4.0%) 8 (3.4%) Myocardial infarction 1 (0.4%) 0 (0.0%) 2 (0.9%) 4 (1.7%) Atrioventricular block first degree 0 (0.0%) 2 (0.7%) 3 (1.3%) 0 (0.0%) Eye disorders 8 (2.9%) 2 (0.7%) 1 (0.4%) 0 (0.0%) Eyelid edema 3 (1.1%) 0 (0.0%) 0 (0.0%) 0 (0.0%) Psychiatric disorders 4 (1.5%) 1 (0.4%) 0 (0.0%) 1 (0.4%) Insomnia 3 (1.1%) 0 (0.0%) 0 (0.0%) 0 (0.0%) Ear and labyrinth disorders 1 (0.4%) 3 (1.1%) 3 (1.3%) 1 (0.4%) 26
28 Appendix C Table 3. Summary of Treatment-Emergent Serious Adverse Events. Face or Scalp Trunk or Extremities Ingenol Vehicle Gel Ingenol Vehicle Gel Mebutate Gel Mebutate Gel System Organ Class 0.015% 0.05% Preferred Term (N=274) (N=271) (N=225) (N=232) Serious AEs All Systems 6 (2.2%) 5 (1.8%) 8 (3.6%) 12 (5.2%) Neoplasms Benign, Malignant and Unspecified (Incl Cysts and Polyps) 3 (1.1%) 3 (1.1%) 5 (2.2%) 9 (3.9%) Basal Cell Carcinoma 3 (1.1%) 1 (0.4%) 3 (1.3%) 4 (1.7%) Squamous Cell Carcinoma 0 (0.0%) 0 (0.0%) 1 (0.4%) 3 (1.3%) Malignant Melanoma 1 (0.4%) 1 (0.4%) 0 (0.0%) 0 (0.0%) Neoplasm Skin 0 (0.0%) 0 (0.0%) 1 (0.4%) 0 (0.0%) Basosquamous Carcinoma 0 (0.0%) 1 (0.4%) 0 (0.0%) 0 (0.0%) Breast Cancer 0 (0.0%) 0 (0.0%) 0 (0.0%) 1 (0.4%) Lymphoma 0 (0.0%) 0 (0.0%) 0 (0.0%) 1 (0.4%) Cardiac Disorders 1 (0.4%) 0 (0.0%) 1 (0.4%) 3 (1.3%) Angina Pectoris 0 (0.0%) 0 (0.0%) 1 (0.4%) 2 (0.9%) Myocardial Infarction 1 (0.4%) 0 (0.0%) 0 (0.0%) 1 (0.4%) Injury, Poisoning, and Procedural Complications 1 (0.4%) 2 (0.7%) 1 (0.4%) 0 (0.0%) Cervical Vertebral Fracture 0 (0.0%) 0 (0.0%) 1 (0.4%) 0 (0.0%) Meniscus Lesion 1 (0.4%) 0 (0.0%) 0 (0.0%) 0 (0.0%) Injury 0 (0.0%) 1 (0.4%) 0 (0.0%) 0 (0.0%) Vascular Pseudoaneurysm 0 (0.0%) 1 (0.4%) 0 (0.0%) 0 (0.0%) Gastrointestinal Disorders 1 (0.4%) 0 (0.0%) 1 (0.4%) 0 (0.0%) Abdominal Pain 0 (0.0%) 0 (0.0%) 1 (0.4%) 0 (0.0%) 27
29 Appendix C Small Intestinal Obstruction 1 (0.4%) 0 (0.0%) 0 (0.0%) 0 (0.0%) Respiratory, Thoracic, and Mediastinal Disorders 1 (0.4%) 1 (0.4%) 0 (0.0%) 0 (0.0%) Hypoxia 1 (0.4%) 0 (0.0%) 0 (0.0%) 0 (0.0%) Pulmonary Embolism 0 (0.0%) 1 (0.4%) 0 (0.0%) 0 (0.0%) Infections and Infestations 1 (0.4%) 0 (0.0%) 0 (0.0%) 0 (0.0%) Campylobacter Infection 1 (0.4%) 0 (0.0%) 0 (0.0%) 0 (0.0%) Surgical and Medical Procedures 1 (0.4%) 0 (0.0%) 0 (0.0%) 0 (0.0%) Hip Arthroplasty 1 (0.4%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 28
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