Post on 01-Feb-2021
transcript
Gilead Sciences, Inc.
Filgotinib RA J-ISS Week 24
Table 1: Subject Disposition (GS-US-417-0301, GS-US-417-0302 and GS-US-417-0303)
Safety Analysis Set
As Randomized Subjects
_______________________________________________________________________________________________________________________________________
Japan Subjects
_________________________________________________________________________________
Filgotinib Filgotinib
200 mg 100 mg Adalimumab Other Total
_______________________________________________________________________________________________________________________________________
Safety Analysis Set 87 67 28 76 258
Study Drug Completion Status Up to Week 24
Completed Study Drug 79 ( 90.8%) 58 ( 86.6%) 22 ( 78.6%) 54 ( 71.1%) 213 ( 82.6%)
Prematurely Discontinued Study Drug 8 ( 9.2%) 9 ( 13.4%) 6 ( 21.4%) 22 ( 28.9%) 45 ( 17.4%)
Study Drug Completion Status
On Study Drug 53 ( 60.9%) 35 ( 52.2%) 15 ( 53.6%) 35 ( 46.1%) 138 ( 53.5%)
Completed Study Drug 23 ( 26.4%) 23 ( 34.3%) 6 ( 21.4%) 13 ( 17.1%) 65 ( 25.2%)
Prematurely Discontinued Study Drug 11 ( 12.6%) 9 ( 13.4%) 7 ( 25.0%) 28 ( 36.8%) 55 ( 21.3%)
Reason for Premature Discontinuation of Study Drug
Lack of Efficacy 5 ( 5.7%) 7 ( 10.4%) 4 ( 14.3%) 16 ( 21.1%) 32 ( 12.4%)
Subject Decision 0 2 ( 3.0%) 0 1 ( 1.3%) 3 ( 1.2%)
Adverse Event 6 ( 6.9%) 0 3 ( 10.7%) 7 ( 9.2%) 16 ( 6.2%)
Lost to Follow-Up 0 0 0 0 0
Investigator's Discretion 0 0 0 3 ( 3.9%) 3 ( 1.2%)
Protocol Violation 0 0 0 1 ( 1.3%) 1 ( 0.4%)
Death 0 0 0 0 0
Non-Compliance With Study Drug 0 0 0 0 0
Pregnancy 0 0 0 0 0
______________________________________________________________________________________________________________________________________________________
Safety Analysis Set includes subjects who received at least 1 dose of study drug of filgotinib 100 mg QD, filgotinib 200 mg QD, adalimumab,
or other (Placebo with or without MTX or csDMARDs, and MTX monotherapy).
Percentages for completion status were calculated based on the number of subjects in the Safety Analysis Set.
For GS-US-417-0301 subjects who were on placebo, they will be considered as completed Week 24 study drug if they were re-randomized.
For GS-US-417-0301 subjects who were on placebo but were not re-randomized, and for subjects who remained on the same treatment in
GS-US-417-0301 and GS-US-417-0303 they will be considered as completed Week 24 study drug if study drug was taken for at least 156 days.
Data Extracted: GS-US-417-0301:05Feb2019; GS-US-417-0302:24Aug2018; GS-US-417-0303:17Jan2019; GS-US-417-0304:11Feb2019; GLPG0634-CL-205:08Aug2018.
Source: .../wk24_japan/version1/prog/t-disp.sas v9.4 Output file: t-disp-rand.out 24MAY2019:22:51 Page 1 of 6
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Gilead Sciences, Inc.
Filgotinib RA J-ISS Week 24
Table 1: Subject Disposition (GS-US-417-0301, GS-US-417-0302 and GS-US-417-0303)
Safety Analysis Set
As Randomized Subjects
_______________________________________________________________________________________________________________________________________
Non-Japan Subjects
_________________________________________________________________________________
Filgotinib Filgotinib
(Continued) 200 mg 100 mg Adalimumab Other Total
_______________________________________________________________________________________________________________________________________
Safety Analysis Set 1161 773 297 963 3194
Study Drug Completion Status Up to Week 24
Completed Study Drug 1036 ( 89.2%) 687 ( 88.9%) 267 ( 89.9%) 801 ( 83.2%) 2791 ( 87.4%)
Prematurely Discontinued Study Drug 125 ( 10.8%) 86 ( 11.1%) 30 ( 10.1%) 162 ( 16.8%) 403 ( 12.6%)
Study Drug Completion Status
On Study Drug 557 ( 48.0%) 324 ( 41.9%) 144 ( 48.5%) 411 ( 42.7%) 1436 ( 45.0%)
Completed Study Drug 420 ( 36.2%) 319 ( 41.3%) 108 ( 36.4%) 322 ( 33.4%) 1169 ( 36.6%)
Prematurely Discontinued Study Drug 184 ( 15.8%) 130 ( 16.8%) 45 ( 15.2%) 230 ( 23.9%) 589 ( 18.4%)
Reason for Premature Discontinuation of Study Drug
Lack of Efficacy 55 ( 4.7%) 41 ( 5.3%) 8 ( 2.7%) 91 ( 9.4%) 195 ( 6.1%)
Subject Decision 40 ( 3.4%) 39 ( 5.0%) 14 ( 4.7%) 64 ( 6.6%) 157 ( 4.9%)
Adverse Event 45 ( 3.9%) 25 ( 3.2%) 15 ( 5.1%) 34 ( 3.5%) 119 ( 3.7%)
Lost to Follow-Up 23 ( 2.0%) 9 ( 1.2%) 1 ( 0.3%) 18 ( 1.9%) 51 ( 1.6%)
Investigator's Discretion 12 ( 1.0%) 10 ( 1.3%) 4 ( 1.3%) 15 ( 1.6%) 41 ( 1.3%)
Protocol Violation 0 2 ( 0.3%) 3 ( 1.0%) 3 ( 0.3%) 8 ( 0.3%)
Death 5 ( 0.4%) 1 ( 0.1%) 0 2 ( 0.2%) 8 ( 0.3%)
Non-Compliance With Study Drug 3 ( 0.3%) 2 ( 0.3%) 0 3 ( 0.3%) 8 ( 0.3%)
Pregnancy 1 (
Gilead Sciences, Inc.
Filgotinib RA J-ISS Week 24
Table 1: Subject Disposition (GS-US-417-0301, GS-US-417-0302 and GS-US-417-0303)
Safety Analysis Set
As Randomized Subjects
_______________________________________________________________________________________________________________________________________
Overall
_________________________________________________________________________________
Filgotinib Filgotinib
(Continued) 200 mg 100 mg Adalimumab Other Total
_______________________________________________________________________________________________________________________________________
Safety Analysis Set 1248 840 325 1039 3452
Study Drug Completion Status Up to Week 24
Completed Study Drug 1115 ( 89.3%) 745 ( 88.7%) 289 ( 88.9%) 855 ( 82.3%) 3004 ( 87.0%)
Prematurely Discontinued Study Drug 133 ( 10.7%) 95 ( 11.3%) 36 ( 11.1%) 184 ( 17.7%) 448 ( 13.0%)
Study Drug Completion Status
On Study Drug 610 ( 48.9%) 359 ( 42.7%) 159 ( 48.9%) 446 ( 42.9%) 1574 ( 45.6%)
Completed Study Drug 443 ( 35.5%) 342 ( 40.7%) 114 ( 35.1%) 335 ( 32.2%) 1234 ( 35.7%)
Prematurely Discontinued Study Drug 195 ( 15.6%) 139 ( 16.5%) 52 ( 16.0%) 258 ( 24.8%) 644 ( 18.7%)
Reason for Premature Discontinuation of Study Drug
Lack of Efficacy 60 ( 4.8%) 48 ( 5.7%) 12 ( 3.7%) 107 ( 10.3%) 227 ( 6.6%)
Subject Decision 40 ( 3.2%) 41 ( 4.9%) 14 ( 4.3%) 65 ( 6.3%) 160 ( 4.6%)
Adverse Event 51 ( 4.1%) 25 ( 3.0%) 18 ( 5.5%) 41 ( 3.9%) 135 ( 3.9%)
Lost to Follow-Up 23 ( 1.8%) 9 ( 1.1%) 1 ( 0.3%) 18 ( 1.7%) 51 ( 1.5%)
Investigator's Discretion 12 ( 1.0%) 10 ( 1.2%) 4 ( 1.2%) 18 ( 1.7%) 44 ( 1.3%)
Protocol Violation 0 2 ( 0.2%) 3 ( 0.9%) 4 ( 0.4%) 9 ( 0.3%)
Death 5 ( 0.4%) 1 ( 0.1%) 0 2 ( 0.2%) 8 ( 0.2%)
Non-Compliance With Study Drug 3 ( 0.2%) 2 ( 0.2%) 0 3 ( 0.3%) 8 ( 0.2%)
Pregnancy 1 (
Gilead Sciences, Inc.
Filgotinib RA J-ISS Week 24
Table 1: Subject Disposition (GS-US-417-0301, GS-US-417-0302 and GS-US-417-0303)
Safety Analysis Set
As Randomized Subjects
_______________________________________________________________________________________________________________________________________
Japan Subjects
_________________________________________________________________________________
Filgotinib Filgotinib
200 mg 100 mg Adalimumab Other Total
_______________________________________________________________________________________________________________________________________
Study Completion Status
On Study 60 ( 69.0%) 39 ( 58.2%) 20 ( 71.4%) 46 ( 60.5%) 165 ( 64.0%)
Completed Study 25 ( 28.7%) 26 ( 38.8%) 6 ( 21.4%) 22 ( 28.9%) 79 ( 30.6%)
Prematurely Discontinued Study 2 ( 2.3%) 2 ( 3.0%) 2 ( 7.1%) 8 ( 10.5%) 14 ( 5.4%)
Reason for Premature Discontinuation of Study
Withdrew Consent 0 1 ( 1.5%) 1 ( 3.6%) 1 ( 1.3%) 3 ( 1.2%)
Investigator's Discretion 0 1 ( 1.5%) 0 4 ( 5.3%) 5 ( 1.9%)
Adverse Event 2 ( 2.3%) 0 1 ( 3.6%) 2 ( 2.6%) 5 ( 1.9%)
Lost to Follow-Up 0 0 0 0 0
Protocol Violation 0 0 0 1 ( 1.3%) 1 ( 0.4%)
Death 0 0 0 0 0
Non-Compliance With Study Drug 0 0 0 0 0
Pregnancy 0 0 0 0 0
Study Terminated By Sponsor 0 0 0 0 0
______________________________________________________________________________________________________________________________________________________
Safety Analysis Set includes subjects who received at least 1 dose of study drug of filgotinib 100 mg QD, filgotinib 200 mg QD, adalimumab,
or other (Placebo with or without MTX or csDMARDs, and MTX monotherapy).
Percentages for completion status were calculated based on the number of subjects in the Safety Analysis Set.
For GS-US-417-0301 subjects who were on placebo, they will be considered as completed Week 24 study drug if they were re-randomized.
For GS-US-417-0301 subjects who were on placebo but were not re-randomized, and for subjects who remained on the same treatment in
GS-US-417-0301 and GS-US-417-0303 they will be considered as completed Week 24 study drug if study drug was taken for at least 156 days.
Data Extracted: GS-US-417-0301:05Feb2019; GS-US-417-0302:24Aug2018; GS-US-417-0303:17Jan2019; GS-US-417-0304:11Feb2019; GLPG0634-CL-205:08Aug2018.
Source: .../wk24_japan/version1/prog/t-disp.sas v9.4 Output file: t-disp-rand.out 24MAY2019:22:51 Page 4 of 6
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Gilead Sciences, Inc.
Filgotinib RA J-ISS Week 24
Table 1: Subject Disposition (GS-US-417-0301, GS-US-417-0302 and GS-US-417-0303)
Safety Analysis Set
As Randomized Subjects
_______________________________________________________________________________________________________________________________________
Non-Japan Subjects
_________________________________________________________________________________
Filgotinib Filgotinib
(Continued) 200 mg 100 mg Adalimumab Other Total
_______________________________________________________________________________________________________________________________________
Study Completion Status
On Study 590 ( 50.8%) 349 ( 45.1%) 154 ( 51.9%) 451 ( 46.8%) 1544 ( 48.3%)
Completed Study 434 ( 37.4%) 332 ( 42.9%) 109 ( 36.7%) 348 ( 36.1%) 1223 ( 38.3%)
Prematurely Discontinued Study 137 ( 11.8%) 92 ( 11.9%) 34 ( 11.4%) 164 ( 17.0%) 427 ( 13.4%)
Reason for Premature Discontinuation of Study
Withdrew Consent 56 ( 4.8%) 47 ( 6.1%) 17 ( 5.7%) 92 ( 9.6%) 212 ( 6.6%)
Investigator's Discretion 24 ( 2.1%) 15 ( 1.9%) 6 ( 2.0%) 25 ( 2.6%) 70 ( 2.2%)
Adverse Event 24 ( 2.1%) 14 ( 1.8%) 5 ( 1.7%) 17 ( 1.8%) 60 ( 1.9%)
Lost to Follow-Up 23 ( 2.0%) 10 ( 1.3%) 2 ( 0.7%) 20 ( 2.1%) 55 ( 1.7%)
Protocol Violation 0 2 ( 0.3%) 3 ( 1.0%) 6 ( 0.6%) 11 ( 0.3%)
Death 5 ( 0.4%) 2 ( 0.3%) 1 ( 0.3%) 2 ( 0.2%) 10 ( 0.3%)
Non-Compliance With Study Drug 3 ( 0.3%) 2 ( 0.3%) 0 2 ( 0.2%) 7 ( 0.2%)
Pregnancy 1 (
Gilead Sciences, Inc.
Filgotinib RA J-ISS Week 24
Table 1: Subject Disposition (GS-US-417-0301, GS-US-417-0302 and GS-US-417-0303)
Safety Analysis Set
As Randomized Subjects
_______________________________________________________________________________________________________________________________________
Overall
_________________________________________________________________________________
Filgotinib Filgotinib
(Continued) 200 mg 100 mg Adalimumab Other Total
_______________________________________________________________________________________________________________________________________
Study Completion Status
On Study 650 ( 52.1%) 388 ( 46.2%) 174 ( 53.5%) 497 ( 47.8%) 1709 ( 49.5%)
Completed Study 459 ( 36.8%) 358 ( 42.6%) 115 ( 35.4%) 370 ( 35.6%) 1302 ( 37.7%)
Prematurely Discontinued Study 139 ( 11.1%) 94 ( 11.2%) 36 ( 11.1%) 172 ( 16.6%) 441 ( 12.8%)
Reason for Premature Discontinuation of Study
Withdrew Consent 56 ( 4.5%) 48 ( 5.7%) 18 ( 5.5%) 93 ( 9.0%) 215 ( 6.2%)
Investigator's Discretion 24 ( 1.9%) 16 ( 1.9%) 6 ( 1.8%) 29 ( 2.8%) 75 ( 2.2%)
Adverse Event 26 ( 2.1%) 14 ( 1.7%) 6 ( 1.8%) 19 ( 1.8%) 65 ( 1.9%)
Lost to Follow-Up 23 ( 1.8%) 10 ( 1.2%) 2 ( 0.6%) 20 ( 1.9%) 55 ( 1.6%)
Protocol Violation 0 2 ( 0.2%) 3 ( 0.9%) 7 ( 0.7%) 12 ( 0.3%)
Death 5 ( 0.4%) 2 ( 0.2%) 1 ( 0.3%) 2 ( 0.2%) 10 ( 0.3%)
Non-Compliance With Study Drug 3 ( 0.2%) 2 ( 0.2%) 0 2 ( 0.2%) 7 ( 0.2%)
Pregnancy 1 (
Gilead Sciences, Inc.
Filgotinib RA J-ISS Week 24
Table 2.1: Demographics and Baseline Characteristics (GS-US-417-0301, GS-US-417-0302, GS-US-417-0303, GLPG0634-CL-203 and GLPG0634-CL-204)
Safety Analysis Set
As Randomized Subjects
____________________________________________________________________________________________________________________________________________________
Japan Subjects
_____________________________________________________________________________________________
Filgotinib Filgotinib Filgotinib
200 mg 100 mg Total Adalimumab Other Total
(N=87) (N=67) (N=154) (N=28) (N=76) (N=258)
____________________________________________________________________________________________________________________________________________________
Age (years)
N 87 67 154 28 76 258
Mean (SD) 54 (13.0) 56 (11.0) 55 (12.2) 54 (10.5) 56 (11.5) 55 (11.8)
Median 56 56 56 56 57 56
Q1, Q3 47, 64 47, 65 47, 64 46, 64 48, 64 48, 64
Min, Max 21, 80 28, 78 21, 80 34, 68 21, 77 21, 80
Age Group
< 65 years 66 ( 75.9%) 50 ( 74.6%) 116 ( 75.3%) 24 ( 85.7%) 58 ( 76.3%) 198 ( 76.7%)
>= 65 years 21 ( 24.1%) 17 ( 25.4%) 38 ( 24.7%) 4 ( 14.3%) 18 ( 23.7%) 60 ( 23.3%)
Sex at Birth
Male 23 ( 26.4%) 17 ( 25.4%) 40 ( 26.0%) 6 ( 21.4%) 22 ( 28.9%) 68 ( 26.4%)
Female 64 ( 73.6%) 50 ( 74.6%) 114 ( 74.0%) 22 ( 78.6%) 54 ( 71.1%) 190 ( 73.6%)
______________________________________________________________________________________________________________________________________________________
Safety Analysis Set includes subjects who received at least 1 dose of study drug of filgotinib 100 mg QD, filgotinib 200 mg QD, adalimumab,
or other (Placebo with or without MTX or csDMARDs, and MTX monotherapy). Not Permitted = local regulators did not allow collection of information.
Denominator for percentages was the Safety Analysis Set. Age was calculated from date of first study drug administration in the parent study.
Geographic Region: Group A: Australia, Austria, Belgium, Canada, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, Republic of Korea,
Singapore, South Africa, Spain, Sweden, Switzerland, United Kingdom, and USA; Group B: Bulgaria, Croatia, Czech Republic, Estonia, India, Latvia,
Georgia, Hungary, Moldova, Poland, Romania, Russia, Slovakia, Serbia and Ukraine; Group C: Argentina, Brazil, Chile, Colombia, Guatemala,
Mexico, Peru and Puerto Rico; Group D: China, Hong Kong, Malaysia, Philippines, Taiwan, Thailand and Vietnam; Group E: Japan
Data Extracted: GS-US-417-0301:05Feb2019; GS-US-417-0302:24Aug2018; GS-US-417-0303:17Jan2019; GS-US-417-0304:11Feb2019; GLPG0634-CL-205:08Aug2018.
Source: .../wk24_japan/version1/prog/t-demog.sas v9.4 Output file: t-demog-rand.out 24MAY2019:22:51 Page 1 of 9
7
Gilead Sciences, Inc.
Filgotinib RA J-ISS Week 24
Table 2.1: Demographics and Baseline Characteristics (GS-US-417-0301, GS-US-417-0302, GS-US-417-0303, GLPG0634-CL-203 and GLPG0634-CL-204)
Safety Analysis Set
As Randomized Subjects
____________________________________________________________________________________________________________________________________________________
Non-Japan Subjects
_____________________________________________________________________________________________
Filgotinib Filgotinib Filgotinib
200 mg 100 mg Total Adalimumab Other Total
(Continued) (N=1316) (N=928) (N=2244) (N=297) (N=1121) (N=3662)
____________________________________________________________________________________________________________________________________________________
Age (years)
N 1316 928 2244 297 1121 3662
Mean (SD) 53 (13.2) 53 (12.5) 53 (12.9) 53 (13.1) 53 (13.1) 53 (13.0)
Median 53 54 54 55 54 54
Q1, Q3 44, 62 45, 62 44, 62 44, 63 44, 62 44, 62
Min, Max 18, 85 19, 86 18, 86 18, 81 18, 87 18, 87
Age Group
< 65 years 1075 ( 81.7%) 755 ( 81.4%) 1830 ( 81.6%) 234 ( 78.8%) 894 ( 79.8%) 2958 ( 80.8%)
>= 65 years 241 ( 18.3%) 173 ( 18.6%) 414 ( 18.4%) 63 ( 21.2%) 227 ( 20.2%) 704 ( 19.2%)
Sex at Birth
Male 256 ( 19.5%) 184 ( 19.8%) 440 ( 19.6%) 53 ( 17.8%) 225 ( 20.1%) 718 ( 19.6%)
Female 1060 ( 80.5%) 744 ( 80.2%) 1804 ( 80.4%) 244 ( 82.2%) 896 ( 79.9%) 2944 ( 80.4%)
______________________________________________________________________________________________________________________________________________________
Safety Analysis Set includes subjects who received at least 1 dose of study drug of filgotinib 100 mg QD, filgotinib 200 mg QD, adalimumab,
or other (Placebo with or without MTX or csDMARDs, and MTX monotherapy). Not Permitted = local regulators did not allow collection of information.
Denominator for percentages was the Safety Analysis Set. Age was calculated from date of first study drug administration in the parent study.
Geographic Region: Group A: Australia, Austria, Belgium, Canada, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, Republic of Korea,
Singapore, South Africa, Spain, Sweden, Switzerland, United Kingdom, and USA; Group B: Bulgaria, Croatia, Czech Republic, Estonia, India, Latvia,
Georgia, Hungary, Moldova, Poland, Romania, Russia, Slovakia, Serbia and Ukraine; Group C: Argentina, Brazil, Chile, Colombia, Guatemala,
Mexico, Peru and Puerto Rico; Group D: China, Hong Kong, Malaysia, Philippines, Taiwan, Thailand and Vietnam; Group E: Japan
Data Extracted: GS-US-417-0301:05Feb2019; GS-US-417-0302:24Aug2018; GS-US-417-0303:17Jan2019; GS-US-417-0304:11Feb2019; GLPG0634-CL-205:08Aug2018.
Source: .../wk24_japan/version1/prog/t-demog.sas v9.4 Output file: t-demog-rand.out 24MAY2019:22:51 Page 2 of 9
8
Gilead Sciences, Inc.
Filgotinib RA J-ISS Week 24
Table 2.1: Demographics and Baseline Characteristics (GS-US-417-0301, GS-US-417-0302, GS-US-417-0303, GLPG0634-CL-203 and GLPG0634-CL-204)
Safety Analysis Set
As Randomized Subjects
____________________________________________________________________________________________________________________________________________________
Overall
_____________________________________________________________________________________________
Filgotinib Filgotinib Filgotinib
200 mg 100 mg Total Adalimumab Other Total
(Continued) (N=1403) (N=995) (N=2398) (N=325) (N=1197) (N=3920)
____________________________________________________________________________________________________________________________________________________
Age (years)
N 1403 995 2398 325 1197 3920
Mean (SD) 53 (13.2) 53 (12.4) 53 (12.9) 53 (12.9) 53 (13.0) 53 (12.9)
Median 54 54 54 55 55 54
Q1, Q3 44, 62 45, 62 45, 62 44, 63 45, 63 44, 62
Min, Max 18, 85 19, 86 18, 86 18, 81 18, 87 18, 87
Age Group
< 65 years 1141 ( 81.3%) 805 ( 80.9%) 1946 ( 81.2%) 258 ( 79.4%) 952 ( 79.5%) 3156 ( 80.5%)
>= 65 years 262 ( 18.7%) 190 ( 19.1%) 452 ( 18.8%) 67 ( 20.6%) 245 ( 20.5%) 764 ( 19.5%)
Sex at Birth
Male 279 ( 19.9%) 201 ( 20.2%) 480 ( 20.0%) 59 ( 18.2%) 247 ( 20.6%) 786 ( 20.1%)
Female 1124 ( 80.1%) 794 ( 79.8%) 1918 ( 80.0%) 266 ( 81.8%) 950 ( 79.4%) 3134 ( 79.9%)
______________________________________________________________________________________________________________________________________________________
Safety Analysis Set includes subjects who received at least 1 dose of study drug of filgotinib 100 mg QD, filgotinib 200 mg QD, adalimumab,
or other (Placebo with or without MTX or csDMARDs, and MTX monotherapy). Not Permitted = local regulators did not allow collection of information.
Denominator for percentages was the Safety Analysis Set. Age was calculated from date of first study drug administration in the parent study.
Geographic Region: Group A: Australia, Austria, Belgium, Canada, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, Republic of Korea,
Singapore, South Africa, Spain, Sweden, Switzerland, United Kingdom, and USA; Group B: Bulgaria, Croatia, Czech Republic, Estonia, India, Latvia,
Georgia, Hungary, Moldova, Poland, Romania, Russia, Slovakia, Serbia and Ukraine; Group C: Argentina, Brazil, Chile, Colombia, Guatemala,
Mexico, Peru and Puerto Rico; Group D: China, Hong Kong, Malaysia, Philippines, Taiwan, Thailand and Vietnam; Group E: Japan
Data Extracted: GS-US-417-0301:05Feb2019; GS-US-417-0302:24Aug2018; GS-US-417-0303:17Jan2019; GS-US-417-0304:11Feb2019; GLPG0634-CL-205:08Aug2018.
Source: .../wk24_japan/version1/prog/t-demog.sas v9.4 Output file: t-demog-rand.out 24MAY2019:22:51 Page 3 of 9
9
Gilead Sciences, Inc.
Filgotinib RA J-ISS Week 24
Table 2.1: Demographics and Baseline Characteristics (GS-US-417-0301, GS-US-417-0302, GS-US-417-0303, GLPG0634-CL-203 and GLPG0634-CL-204)
Safety Analysis Set
As Randomized Subjects
____________________________________________________________________________________________________________________________________________________
Japan Subjects
_____________________________________________________________________________________________
Filgotinib Filgotinib Filgotinib
200 mg 100 mg Total Adalimumab Other Total
(N=87) (N=67) (N=154) (N=28) (N=76) (N=258)
____________________________________________________________________________________________________________________________________________________
Race
American Indian or Alaska Native 0 0 0 0 0 0
Asian 87 (100.0%) 67 (100.0%) 154 (100.0%) 28 (100.0%) 76 (100.0%) 258 (100.0%)
Black or African American 0 0 0 0 0 0
Native Hawaiian or Pacific Islander 0 0 0 0 0 0
White 0 0 0 0 0 0
Other 0 0 0 0 0 0
Not Permitted 0 0 0 0 0 0
Ethnicity
Hispanic or Latino 0 1 ( 1.5%) 1 ( 0.6%) 0 0 1 ( 0.4%)
Not Hispanic or Latino 87 (100.0%) 66 ( 98.5%) 153 ( 99.4%) 28 (100.0%) 76 (100.0%) 257 ( 99.6%)
Not Permitted 0 0 0 0 0 0
______________________________________________________________________________________________________________________________________________________
Safety Analysis Set includes subjects who received at least 1 dose of study drug of filgotinib 100 mg QD, filgotinib 200 mg QD, adalimumab,
or other (Placebo with or without MTX or csDMARDs, and MTX monotherapy). Not Permitted = local regulators did not allow collection of information.
Denominator for percentages was the Safety Analysis Set. Age was calculated from date of first study drug administration in the parent study.
Geographic Region: Group A: Australia, Austria, Belgium, Canada, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, Republic of Korea,
Singapore, South Africa, Spain, Sweden, Switzerland, United Kingdom, and USA; Group B: Bulgaria, Croatia, Czech Republic, Estonia, India, Latvia,
Georgia, Hungary, Moldova, Poland, Romania, Russia, Slovakia, Serbia and Ukraine; Group C: Argentina, Brazil, Chile, Colombia, Guatemala,
Mexico, Peru and Puerto Rico; Group D: China, Hong Kong, Malaysia, Philippines, Taiwan, Thailand and Vietnam; Group E: Japan
Data Extracted: GS-US-417-0301:05Feb2019; GS-US-417-0302:24Aug2018; GS-US-417-0303:17Jan2019; GS-US-417-0304:11Feb2019; GLPG0634-CL-205:08Aug2018.
Source: .../wk24_japan/version1/prog/t-demog.sas v9.4 Output file: t-demog-rand.out 24MAY2019:22:51 Page 4 of 9
10
Gilead Sciences, Inc.
Filgotinib RA J-ISS Week 24
Table 2.1: Demographics and Baseline Characteristics (GS-US-417-0301, GS-US-417-0302, GS-US-417-0303, GLPG0634-CL-203 and GLPG0634-CL-204)
Safety Analysis Set
As Randomized Subjects
____________________________________________________________________________________________________________________________________________________
Non-Japan Subjects
_____________________________________________________________________________________________
Filgotinib Filgotinib Filgotinib
200 mg 100 mg Total Adalimumab Other Total
(Continued) (N=1316) (N=928) (N=2244) (N=297) (N=1121) (N=3662)
____________________________________________________________________________________________________________________________________________________
Race
American Indian or Alaska Native 77 ( 5.9%) 47 ( 5.1%) 124 ( 5.5%) 19 ( 6.4%) 70 ( 6.2%) 213 ( 5.8%)
Asian 187 ( 14.2%) 120 ( 12.9%) 307 ( 13.7%) 37 ( 12.5%) 132 ( 11.8%) 476 ( 13.0%)
Black or African American 44 ( 3.3%) 28 ( 3.0%) 72 ( 3.2%) 10 ( 3.4%) 49 ( 4.4%) 131 ( 3.6%)
Native Hawaiian or Pacific Islander 3 ( 0.2%) 0 3 ( 0.1%) 0 6 ( 0.5%) 9 ( 0.2%)
White 955 ( 72.6%) 680 ( 73.3%) 1635 ( 72.9%) 227 ( 76.4%) 806 ( 71.9%) 2668 ( 72.9%)
Other 49 ( 3.7%) 52 ( 5.6%) 101 ( 4.5%) 4 ( 1.3%) 54 ( 4.8%) 159 ( 4.3%)
Not Permitted 1 (
Gilead Sciences, Inc.
Filgotinib RA J-ISS Week 24
Table 2.1: Demographics and Baseline Characteristics (GS-US-417-0301, GS-US-417-0302, GS-US-417-0303, GLPG0634-CL-203 and GLPG0634-CL-204)
Safety Analysis Set
As Randomized Subjects
____________________________________________________________________________________________________________________________________________________
Overall
_____________________________________________________________________________________________
Filgotinib Filgotinib Filgotinib
200 mg 100 mg Total Adalimumab Other Total
(Continued) (N=1403) (N=995) (N=2398) (N=325) (N=1197) (N=3920)
____________________________________________________________________________________________________________________________________________________
Race
American Indian or Alaska Native 77 ( 5.5%) 47 ( 4.7%) 124 ( 5.2%) 19 ( 5.8%) 70 ( 5.8%) 213 ( 5.4%)
Asian 274 ( 19.5%) 187 ( 18.8%) 461 ( 19.2%) 65 ( 20.0%) 208 ( 17.4%) 734 ( 18.7%)
Black or African American 44 ( 3.1%) 28 ( 2.8%) 72 ( 3.0%) 10 ( 3.1%) 49 ( 4.1%) 131 ( 3.3%)
Native Hawaiian or Pacific Islander 3 ( 0.2%) 0 3 ( 0.1%) 0 6 ( 0.5%) 9 ( 0.2%)
White 955 ( 68.1%) 680 ( 68.3%) 1635 ( 68.2%) 227 ( 69.8%) 806 ( 67.3%) 2668 ( 68.1%)
Other 49 ( 3.5%) 52 ( 5.2%) 101 ( 4.2%) 4 ( 1.2%) 54 ( 4.5%) 159 ( 4.1%)
Not Permitted 1 (
Gilead Sciences, Inc.
Filgotinib RA J-ISS Week 24
Table 2.1: Demographics and Baseline Characteristics (GS-US-417-0301, GS-US-417-0302, GS-US-417-0303, GLPG0634-CL-203 and GLPG0634-CL-204)
Safety Analysis Set
As Randomized Subjects
____________________________________________________________________________________________________________________________________________________
Japan Subjects
_____________________________________________________________________________________________
Filgotinib Filgotinib Filgotinib
200 mg 100 mg Total Adalimumab Other Total
(N=87) (N=67) (N=154) (N=28) (N=76) (N=258)
____________________________________________________________________________________________________________________________________________________
Geographic Region
Group A 0 0 0 0 0 0
Group B 0 0 0 0 0 0
Group C 0 0 0 0 0 0
Group D 0 0 0 0 0 0
Group E 87 (100.0%) 67 (100.0%) 154 (100.0%) 28 (100.0%) 76 (100.0%) 258 (100.0%)
Concurrent Oral Corticosteroids Use on First Dosing
Date in Parent Study
Yes 29 ( 33.3%) 21 ( 31.3%) 50 ( 32.5%) 8 ( 28.6%) 31 ( 40.8%) 89 ( 34.5%)
No 58 ( 66.7%) 46 ( 68.7%) 104 ( 67.5%) 20 ( 71.4%) 45 ( 59.2%) 169 ( 65.5%)
Concurrent csDMARDs Use on First Dosing Date in
Parent Study
Yes 75 ( 86.2%) 67 (100.0%) 142 ( 92.2%) 28 (100.0%) 76 (100.0%) 246 ( 95.3%)
No 12 ( 13.8%) 0 12 ( 7.8%) 0 0 12 ( 4.7%)
Prior Exposure to bDMARDs on First dosing Date in
Parent Study
Yes 12 ( 13.8%) 15 ( 22.4%) 27 ( 17.5%) 0 13 ( 17.1%) 40 ( 15.5%)
No 75 ( 86.2%) 52 ( 77.6%) 127 ( 82.5%) 28 (100.0%) 63 ( 82.9%) 218 ( 84.5%)
______________________________________________________________________________________________________________________________________________________
Safety Analysis Set includes subjects who received at least 1 dose of study drug of filgotinib 100 mg QD, filgotinib 200 mg QD, adalimumab,
or other (Placebo with or without MTX or csDMARDs, and MTX monotherapy). Not Permitted = local regulators did not allow collection of information.
Denominator for percentages was the Safety Analysis Set. Age was calculated from date of first study drug administration in the parent study.
Geographic Region: Group A: Australia, Austria, Belgium, Canada, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, Republic of Korea,
Singapore, South Africa, Spain, Sweden, Switzerland, United Kingdom, and USA; Group B: Bulgaria, Croatia, Czech Republic, Estonia, India, Latvia,
Georgia, Hungary, Moldova, Poland, Romania, Russia, Slovakia, Serbia and Ukraine; Group C: Argentina, Brazil, Chile, Colombia, Guatemala,
Mexico, Peru and Puerto Rico; Group D: China, Hong Kong, Malaysia, Philippines, Taiwan, Thailand and Vietnam; Group E: Japan
Data Extracted: GS-US-417-0301:05Feb2019; GS-US-417-0302:24Aug2018; GS-US-417-0303:17Jan2019; GS-US-417-0304:11Feb2019; GLPG0634-CL-205:08Aug2018.
Source: .../wk24_japan/version1/prog/t-demog.sas v9.4 Output file: t-demog-rand.out 24MAY2019:22:51 Page 7 of 9
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Filgotinib RA J-ISS Week 24
Table 2.1: Demographics and Baseline Characteristics (GS-US-417-0301, GS-US-417-0302, GS-US-417-0303, GLPG0634-CL-203 and GLPG0634-CL-204)
Safety Analysis Set
As Randomized Subjects
____________________________________________________________________________________________________________________________________________________
Non-Japan Subjects
_____________________________________________________________________________________________
Filgotinib Filgotinib Filgotinib
200 mg 100 mg Total Adalimumab Other Total
(Continued) (N=1316) (N=928) (N=2244) (N=297) (N=1121) (N=3662)
____________________________________________________________________________________________________________________________________________________
Geographic Region
Group A 502 ( 38.1%) 326 ( 35.1%) 828 ( 36.9%) 73 ( 24.6%) 412 ( 36.8%) 1313 ( 35.9%)
Group B 573 ( 43.5%) 428 ( 46.1%) 1001 ( 44.6%) 175 ( 58.9%) 499 ( 44.5%) 1675 ( 45.7%)
Group C 200 ( 15.2%) 148 ( 15.9%) 348 ( 15.5%) 35 ( 11.8%) 172 ( 15.3%) 555 ( 15.2%)
Group D 41 ( 3.1%) 26 ( 2.8%) 67 ( 3.0%) 14 ( 4.7%) 38 ( 3.4%) 119 ( 3.2%)
Group E 0 0 0 0 0 0
Concurrent Oral Corticosteroids Use on First Dosing
Date in Parent Study
Yes 463 ( 35.2%) 336 ( 36.2%) 799 ( 35.6%) 121 ( 40.7%) 408 ( 36.4%) 1328 ( 36.3%)
No 853 ( 64.8%) 592 ( 63.8%) 1445 ( 64.4%) 176 ( 59.3%) 713 ( 63.6%) 2334 ( 63.7%)
Concurrent csDMARDs Use on First Dosing Date in
Parent Study
Yes 1069 ( 81.2%) 861 ( 92.8%) 1930 ( 86.0%) 297 (100.0%) 1052 ( 93.8%) 3279 ( 89.5%)
No 247 ( 18.8%) 67 ( 7.2%) 314 ( 14.0%) 0 69 ( 6.2%) 383 ( 10.5%)
Prior Exposure to bDMARDs on First dosing Date in
Parent Study
Yes 169 ( 12.8%) 165 ( 17.8%) 334 ( 14.9%) 8 ( 2.7%) 151 ( 13.5%) 493 ( 13.5%)
No 1147 ( 87.2%) 763 ( 82.2%) 1910 ( 85.1%) 289 ( 97.3%) 970 ( 86.5%) 3169 ( 86.5%)
______________________________________________________________________________________________________________________________________________________
Safety Analysis Set includes subjects who received at least 1 dose of study drug of filgotinib 100 mg QD, filgotinib 200 mg QD, adalimumab,
or other (Placebo with or without MTX or csDMARDs, and MTX monotherapy). Not Permitted = local regulators did not allow collection of information.
Denominator for percentages was the Safety Analysis Set. Age was calculated from date of first study drug administration in the parent study.
Geographic Region: Group A: Australia, Austria, Belgium, Canada, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, Republic of Korea,
Singapore, South Africa, Spain, Sweden, Switzerland, United Kingdom, and USA; Group B: Bulgaria, Croatia, Czech Republic, Estonia, India, Latvia,
Georgia, Hungary, Moldova, Poland, Romania, Russia, Slovakia, Serbia and Ukraine; Group C: Argentina, Brazil, Chile, Colombia, Guatemala,
Mexico, Peru and Puerto Rico; Group D: China, Hong Kong, Malaysia, Philippines, Taiwan, Thailand and Vietnam; Group E: Japan
Data Extracted: GS-US-417-0301:05Feb2019; GS-US-417-0302:24Aug2018; GS-US-417-0303:17Jan2019; GS-US-417-0304:11Feb2019; GLPG0634-CL-205:08Aug2018.
Source: .../wk24_japan/version1/prog/t-demog.sas v9.4 Output file: t-demog-rand.out 24MAY2019:22:51 Page 8 of 9
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Gilead Sciences, Inc.
Filgotinib RA J-ISS Week 24
Table 2.1: Demographics and Baseline Characteristics (GS-US-417-0301, GS-US-417-0302, GS-US-417-0303, GLPG0634-CL-203 and GLPG0634-CL-204)
Safety Analysis Set
As Randomized Subjects
____________________________________________________________________________________________________________________________________________________
Overall
_____________________________________________________________________________________________
Filgotinib Filgotinib Filgotinib
200 mg 100 mg Total Adalimumab Other Total
(Continued) (N=1403) (N=995) (N=2398) (N=325) (N=1197) (N=3920)
____________________________________________________________________________________________________________________________________________________
Geographic Region
Group A 502 ( 35.8%) 326 ( 32.8%) 828 ( 34.5%) 73 ( 22.5%) 412 ( 34.4%) 1313 ( 33.5%)
Group B 573 ( 40.8%) 428 ( 43.0%) 1001 ( 41.7%) 175 ( 53.8%) 499 ( 41.7%) 1675 ( 42.7%)
Group C 200 ( 14.3%) 148 ( 14.9%) 348 ( 14.5%) 35 ( 10.8%) 172 ( 14.4%) 555 ( 14.2%)
Group D 41 ( 2.9%) 26 ( 2.6%) 67 ( 2.8%) 14 ( 4.3%) 38 ( 3.2%) 119 ( 3.0%)
Group E 87 ( 6.2%) 67 ( 6.7%) 154 ( 6.4%) 28 ( 8.6%) 76 ( 6.3%) 258 ( 6.6%)
Concurrent Oral Corticosteroids Use on First Dosing
Date in Parent Study
Yes 492 ( 35.1%) 357 ( 35.9%) 849 ( 35.4%) 129 ( 39.7%) 439 ( 36.7%) 1417 ( 36.1%)
No 911 ( 64.9%) 638 ( 64.1%) 1549 ( 64.6%) 196 ( 60.3%) 758 ( 63.3%) 2503 ( 63.9%)
Concurrent csDMARDs Use on First Dosing Date in
Parent Study
Yes 1144 ( 81.5%) 928 ( 93.3%) 2072 ( 86.4%) 325 (100.0%) 1128 ( 94.2%) 3525 ( 89.9%)
No 259 ( 18.5%) 67 ( 6.7%) 326 ( 13.6%) 0 69 ( 5.8%) 395 ( 10.1%)
Prior Exposure to bDMARDs on First dosing Date in
Parent Study
Yes 181 ( 12.9%) 180 ( 18.1%) 361 ( 15.1%) 8 ( 2.5%) 164 ( 13.7%) 533 ( 13.6%)
No 1222 ( 87.1%) 815 ( 81.9%) 2037 ( 84.9%) 317 ( 97.5%) 1033 ( 86.3%) 3387 ( 86.4%)
______________________________________________________________________________________________________________________________________________________
Safety Analysis Set includes subjects who received at least 1 dose of study drug of filgotinib 100 mg QD, filgotinib 200 mg QD, adalimumab,
or other (Placebo with or without MTX or csDMARDs, and MTX monotherapy). Not Permitted = local regulators did not allow collection of information.
Denominator for percentages was the Safety Analysis Set. Age was calculated from date of first study drug administration in the parent study.
Geographic Region: Group A: Australia, Austria, Belgium, Canada, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, Republic of Korea,
Singapore, South Africa, Spain, Sweden, Switzerland, United Kingdom, and USA; Group B: Bulgaria, Croatia, Czech Republic, Estonia, India, Latvia,
Georgia, Hungary, Moldova, Poland, Romania, Russia, Slovakia, Serbia and Ukraine; Group C: Argentina, Brazil, Chile, Colombia, Guatemala,
Mexico, Peru and Puerto Rico; Group D: China, Hong Kong, Malaysia, Philippines, Taiwan, Thailand and Vietnam; Group E: Japan
Data Extracted: GS-US-417-0301:05Feb2019; GS-US-417-0302:24Aug2018; GS-US-417-0303:17Jan2019; GS-US-417-0304:11Feb2019; GLPG0634-CL-205:08Aug2018.
Source: .../wk24_japan/version1/prog/t-demog.sas v9.4 Output file: t-demog-rand.out 24MAY2019:22:51 Page 9 of 9
15
Gilead Sciences, Inc.
Filgotinib RA J-ISS Week 24
Table 3.1: Extent of Exposure to Study Drug
Safety Analysis Set
As Randomized Subjects
____________________________________________________________________________________________________________________________________________
Japan Subjects
______________________________________________________________________________
Filgotinib Filgotinib Filgotinib
200 mg 100 mg Total Adalimumab Other
(N=87) (N=67) (N=154) (N=28) (N=76)
____________________________________________________________________________________________________________________________________________
Total Duration of Exposure to Study Drug (Weeks)
N 87 67 154 28 76
Mean (SD) 40.3 (16.00) 40.0 (17.29) 40.1 (16.52) 33.7 (13.87) 23.9 (10.64)
Median 38.7 38.9 38.8 32.2 24.0
Q1, Q3 29.6, 49.9 29.6, 50.1 29.6, 49.9 27.9, 47.9 14.2, 27.1
Min, Max 3.7, 79.7 2.4, 79.1 2.4, 79.7 8.4, 52.3 1.0, 52.1
Total Duration of Exposure to Study Drug (Years)
N 87 67 154 28 76
Mean (SD) 0.8 (0.31) 0.8 (0.33) 0.8 (0.32) 0.6 (0.27) 0.5 (0.20)
Median 0.7 0.7 0.7 0.6 0.5
Q1, Q3 0.6, 1.0 0.6, 1.0 0.6, 1.0 0.5, 0.9 0.3, 0.5
Min, Max 0.1, 1.5 0.0, 1.5 0.0, 1.5 0.2, 1.0 0.0, 1.0
Cumulative N (%) of Subjects Exposed to Study Drug
1 Day [Day 1] 87 (100.0%) 67 (100.0%) 154 (100.0%) 28 (100.0%) 76 (100.0%)
Week 12 [Day 85] 82 ( 94.3%) 65 ( 97.0%) 147 ( 95.5%) 27 ( 96.4%) 70 ( 92.1%)
Week 24 [Day 169] 78 ( 89.7%) 58 ( 86.6%) 136 ( 88.3%) 22 ( 78.6%) 31 ( 40.8%)
Week 36 [Day 253] 49 ( 56.3%) 37 ( 55.2%) 86 ( 55.8%) 10 ( 35.7%) 8 ( 10.5%)
Week 48 [Day 337] 24 ( 27.6%) 20 ( 29.9%) 44 ( 28.6%) 7 ( 25.0%) 3 ( 3.9%)
Week 52 [Day 365] 20 ( 23.0%) 15 ( 22.4%) 35 ( 22.7%) 6 ( 21.4%) 3 ( 3.9%)
Week 60 [Day 421] 13 ( 14.9%) 7 ( 10.4%) 20 ( 13.0%) 0 0
______________________________________________________________________________________________________________________________________________________
Safety Analysis Set includes subjects who received at least 1 dose of study drug of filgotinib 100 mg QD, filgotinib 200 mg QD, adalimumab,
or other (Placebo with or without MTX or csDMARDs, and MTX monotherapy).
Duration of exposure to study drug (weeks) = (last dosing date - first dosing date + 1)/7
Duration of exposure to study drug (years) = (last dosing date - first dosing date + 1)/365.25
A 7-day window is applied to Week 52.
Data Extracted: GS-US-417-0301:05Feb2019; GS-US-417-0302:24Aug2018; GS-US-417-0303:17Jan2019; GS-US-417-0304:11Feb2019; GLPG0634-CL-205:08Aug2018.
Source: .../wk24_japan/version1/prog/t-exp-drug.sas v9.4 Output file: t-exp-drug-rand.out 24MAY2019:22:51 Page 1 of 6
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Gilead Sciences, Inc.
Filgotinib RA J-ISS Week 24
Table 3.1: Extent of Exposure to Study Drug
Safety Analysis Set
As Randomized Subjects
____________________________________________________________________________________________________________________________________________
Non-Japan Subjects
______________________________________________________________________________
Filgotinib Filgotinib Filgotinib
200 mg 100 mg Total Adalimumab Other
(Continued) (N=1316) (N=928) (N=2244) (N=297) (N=1121)
____________________________________________________________________________________________________________________________________________
Total Duration of Exposure to Study Drug (Weeks)
N 1316 928 2244 297 1121
Mean (SD) 55.3 (44.09) 42.6 (21.99) 50.1 (37.14) 40.4 (12.74) 25.8 (12.05)
Median 43.7 39.6 42.1 42.9 24.0
Q1, Q3 30.6, 63.4 24.3, 56.9 28.9, 60.9 33.1, 52.0 23.3, 28.6
Min, Max 0.7, 246.1 0.3, 194.9 0.3, 246.1 1.6, 53.4 0.3, 54.0
Total Duration of Exposure to Study Drug (Years)
N 1316 928 2244 297 1121
Mean (SD) 1.1 (0.85) 0.8 (0.42) 1.0 (0.71) 0.8 (0.24) 0.5 (0.23)
Median 0.8 0.8 0.8 0.8 0.5
Q1, Q3 0.6, 1.2 0.5, 1.1 0.6, 1.2 0.6, 1.0 0.4, 0.5
Min, Max 0.0, 4.7 0.0, 3.7 0.0, 4.7 0.0, 1.0 0.0, 1.0
Cumulative N (%) of Subjects Exposed to Study Drug
1 Day [Day 1] 1316 (100.0%) 928 (100.0%) 2244 (100.0%) 297 (100.0%) 1121 (100.0%)
Week 12 [Day 85] 1256 ( 95.4%) 887 ( 95.6%) 2143 ( 95.5%) 282 ( 94.9%) 968 ( 86.4%)
Week 24 [Day 169] 1162 ( 88.3%) 741 ( 79.8%) 1903 ( 84.8%) 267 ( 89.9%) 533 ( 47.5%)
Week 36 [Day 253] 841 ( 63.9%) 527 ( 56.8%) 1368 ( 61.0%) 203 ( 68.4%) 189 ( 16.9%)
Week 48 [Day 337] 549 ( 41.7%) 326 ( 35.1%) 875 ( 39.0%) 120 ( 40.4%) 109 ( 9.7%)
Week 52 [Day 365] 507 ( 38.5%) 298 ( 32.1%) 805 ( 35.9%) 111 ( 37.4%) 92 ( 8.2%)
Week 60 [Day 421] 376 ( 28.6%) 203 ( 21.9%) 579 ( 25.8%) 0 0
______________________________________________________________________________________________________________________________________________________
Safety Analysis Set includes subjects who received at least 1 dose of study drug of filgotinib 100 mg QD, filgotinib 200 mg QD, adalimumab,
or other (Placebo with or without MTX or csDMARDs, and MTX monotherapy).
Duration of exposure to study drug (weeks) = (last dosing date - first dosing date + 1)/7
Duration of exposure to study drug (years) = (last dosing date - first dosing date + 1)/365.25
A 7-day window is applied to Week 52.
Data Extracted: GS-US-417-0301:05Feb2019; GS-US-417-0302:24Aug2018; GS-US-417-0303:17Jan2019; GS-US-417-0304:11Feb2019; GLPG0634-CL-205:08Aug2018.
Source: .../wk24_japan/version1/prog/t-exp-drug.sas v9.4 Output file: t-exp-drug-rand.out 24MAY2019:22:51 Page 2 of 6
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Gilead Sciences, Inc.
Filgotinib RA J-ISS Week 24
Table 3.1: Extent of Exposure to Study Drug
Safety Analysis Set
As Randomized Subjects
____________________________________________________________________________________________________________________________________________
Overall
______________________________________________________________________________
Filgotinib Filgotinib Filgotinib
200 mg 100 mg Total Adalimumab Other
(Continued) (N=1403) (N=995) (N=2398) (N=325) (N=1197)
____________________________________________________________________________________________________________________________________________
Total Duration of Exposure to Study Drug (Weeks)
N 1403 995 2398 325 1197
Mean (SD) 54.4 (43.04) 42.4 (21.71) 49.4 (36.25) 39.9 (12.96) 25.7 (11.97)
Median 43.6 39.6 42.0 42.0 24.0
Q1, Q3 30.1, 62.9 24.4, 56.7 28.9, 60.0 32.6, 52.0 23.3, 28.1
Min, Max 0.7, 246.1 0.3, 194.9 0.3, 246.1 1.6, 53.4 0.3, 54.0
Total Duration of Exposure to Study Drug (Years)
N 1403 995 2398 325 1197
Mean (SD) 1.0 (0.82) 0.8 (0.42) 0.9 (0.69) 0.8 (0.25) 0.5 (0.23)
Median 0.8 0.8 0.8 0.8 0.5
Q1, Q3 0.6, 1.2 0.5, 1.1 0.6, 1.1 0.6, 1.0 0.4, 0.5
Min, Max 0.0, 4.7 0.0, 3.7 0.0, 4.7 0.0, 1.0 0.0, 1.0
Cumulative N (%) of Subjects Exposed to Study Drug
1 Day [Day 1] 1403 (100.0%) 995 (100.0%) 2398 (100.0%) 325 (100.0%) 1197 (100.0%)
Week 12 [Day 85] 1338 ( 95.4%) 952 ( 95.7%) 2290 ( 95.5%) 309 ( 95.1%) 1038 ( 86.7%)
Week 24 [Day 169] 1240 ( 88.4%) 799 ( 80.3%) 2039 ( 85.0%) 289 ( 88.9%) 564 ( 47.1%)
Week 36 [Day 253] 890 ( 63.4%) 564 ( 56.7%) 1454 ( 60.6%) 213 ( 65.5%) 197 ( 16.5%)
Week 48 [Day 337] 573 ( 40.8%) 346 ( 34.8%) 919 ( 38.3%) 127 ( 39.1%) 112 ( 9.4%)
Week 52 [Day 365] 527 ( 37.6%) 313 ( 31.5%) 840 ( 35.0%) 117 ( 36.0%) 95 ( 7.9%)
Week 60 [Day 421] 389 ( 27.7%) 210 ( 21.1%) 599 ( 25.0%) 0 0
______________________________________________________________________________________________________________________________________________________
Safety Analysis Set includes subjects who received at least 1 dose of study drug of filgotinib 100 mg QD, filgotinib 200 mg QD, adalimumab,
or other (Placebo with or without MTX or csDMARDs, and MTX monotherapy).
Duration of exposure to study drug (weeks) = (last dosing date - first dosing date + 1)/7
Duration of exposure to study drug (years) = (last dosing date - first dosing date + 1)/365.25
A 7-day window is applied to Week 52.
Data Extracted: GS-US-417-0301:05Feb2019; GS-US-417-0302:24Aug2018; GS-US-417-0303:17Jan2019; GS-US-417-0304:11Feb2019; GLPG0634-CL-205:08Aug2018.
Source: .../wk24_japan/version1/prog/t-exp-drug.sas v9.4 Output file: t-exp-drug-rand.out 24MAY2019:22:51 Page 3 of 6
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Gilead Sciences, Inc.
Filgotinib RA J-ISS Week 24
Table 3.1: Extent of Exposure to Study Drug
Safety Analysis Set
As Randomized Subjects
____________________________________________________________________________________________________________________________________________
Japan Subjects
______________________________________________________________________________
Filgotinib Filgotinib Filgotinib
200 mg 100 mg Total Adalimumab Other
(N=87) (N=67) (N=154) (N=28) (N=76)
____________________________________________________________________________________________________________________________________________
Cumulative N (%) of Subjects Exposed to Study Drug
Week 72 [Day 505] 4 ( 4.6%) 5 ( 7.5%) 9 ( 5.8%) 0 0
Week 84 [Day 589] 0 0 0 0 0
Week 96 [Day 673] 0 0 0 0 0
Week 108 [Day 757] 0 0 0 0 0
Week 120 [Day 841] 0 0 0 0 0
Week 132 [Day 925] 0 0 0 0 0
Week 144 [Day 1009] 0 0 0 0 0
Week 156 [Day 1093] 0 0 0 0 0
Week 168 [Day 1177] 0 0 0 0 0
Week 180 [Day 1261] 0 0 0 0 0
Week 192 [Day 1345] 0 0 0 0 0
Week 204 [Day 1429] 0 0 0 0 0
Week 216 [Day 1513] 0 0 0 0 0
Week 228 [Day 1597] 0 0 0 0 0
Week 240 [Day 1681] 0 0 0 0 0
______________________________________________________________________________________________________________________________________________________
Safety Analysis Set includes subjects who received at least 1 dose of study drug of filgotinib 100 mg QD, filgotinib 200 mg QD, adalimumab,
or other (Placebo with or without MTX or csDMARDs, and MTX monotherapy).
Duration of exposure to study drug (weeks) = (last dosing date - first dosing date + 1)/7
Duration of exposure to study drug (years) = (last dosing date - first dosing date + 1)/365.25
A 7-day window is applied to Week 52.
Data Extracted: GS-US-417-0301:05Feb2019; GS-US-417-0302:24Aug2018; GS-US-417-0303:17Jan2019; GS-US-417-0304:11Feb2019; GLPG0634-CL-205:08Aug2018.
Source: .../wk24_japan/version1/prog/t-exp-drug.sas v9.4 Output file: t-exp-drug-rand.out 24MAY2019:22:51 Page 4 of 6
19
Gilead Sciences, Inc.
Filgotinib RA J-ISS Week 24
Table 3.1: Extent of Exposure to Study Drug
Safety Analysis Set
As Randomized Subjects
____________________________________________________________________________________________________________________________________________
Non-Japan Subjects
______________________________________________________________________________
Filgotinib Filgotinib Filgotinib
200 mg 100 mg Total Adalimumab Other
(Continued) (N=1316) (N=928) (N=2244) (N=297) (N=1121)
____________________________________________________________________________________________________________________________________________
Cumulative N (%) of Subjects Exposed to Study Drug
Week 72 [Day 505] 225 ( 17.1%) 74 ( 8.0%) 299 ( 13.3%) 0 0
Week 84 [Day 589] 151 ( 11.5%) 33 ( 3.6%) 184 ( 8.2%) 0 0
Week 96 [Day 673] 120 ( 9.1%) 11 ( 1.2%) 131 ( 5.8%) 0 0
Week 108 [Day 757] 102 ( 7.8%) 4 ( 0.4%) 106 ( 4.7%) 0 0
Week 120 [Day 841] 99 ( 7.5%) 4 ( 0.4%) 103 ( 4.6%) 0 0
Week 132 [Day 925] 95 ( 7.2%) 3 ( 0.3%) 98 ( 4.4%) 0 0
Week 144 [Day 1009] 92 ( 7.0%) 3 ( 0.3%) 95 ( 4.2%) 0 0
Week 156 [Day 1093] 91 ( 6.9%) 3 ( 0.3%) 94 ( 4.2%) 0 0
Week 168 [Day 1177] 90 ( 6.8%) 2 ( 0.2%) 92 ( 4.1%) 0 0
Week 180 [Day 1261] 85 ( 6.5%) 2 ( 0.2%) 87 ( 3.9%) 0 0
Week 192 [Day 1345] 49 ( 3.7%) 1 ( 0.1%) 50 ( 2.2%) 0 0
Week 204 [Day 1429] 24 ( 1.8%) 0 24 ( 1.1%) 0 0
Week 216 [Day 1513] 11 ( 0.8%) 0 11 ( 0.5%) 0 0
Week 228 [Day 1597] 6 ( 0.5%) 0 6 ( 0.3%) 0 0
Week 240 [Day 1681] 1 (
Gilead Sciences, Inc.
Filgotinib RA J-ISS Week 24
Table 3.1: Extent of Exposure to Study Drug
Safety Analysis Set
As Randomized Subjects
____________________________________________________________________________________________________________________________________________
Overall
______________________________________________________________________________
Filgotinib Filgotinib Filgotinib
200 mg 100 mg Total Adalimumab Other
(Continued) (N=1403) (N=995) (N=2398) (N=325) (N=1197)
____________________________________________________________________________________________________________________________________________
Cumulative N (%) of Subjects Exposed to Study Drug
Week 72 [Day 505] 229 ( 16.3%) 79 ( 7.9%) 308 ( 12.8%) 0 0
Week 84 [Day 589] 151 ( 10.8%) 33 ( 3.3%) 184 ( 7.7%) 0 0
Week 96 [Day 673] 120 ( 8.6%) 11 ( 1.1%) 131 ( 5.5%) 0 0
Week 108 [Day 757] 102 ( 7.3%) 4 ( 0.4%) 106 ( 4.4%) 0 0
Week 120 [Day 841] 99 ( 7.1%) 4 ( 0.4%) 103 ( 4.3%) 0 0
Week 132 [Day 925] 95 ( 6.8%) 3 ( 0.3%) 98 ( 4.1%) 0 0
Week 144 [Day 1009] 92 ( 6.6%) 3 ( 0.3%) 95 ( 4.0%) 0 0
Week 156 [Day 1093] 91 ( 6.5%) 3 ( 0.3%) 94 ( 3.9%) 0 0
Week 168 [Day 1177] 90 ( 6.4%) 2 ( 0.2%) 92 ( 3.8%) 0 0
Week 180 [Day 1261] 85 ( 6.1%) 2 ( 0.2%) 87 ( 3.6%) 0 0
Week 192 [Day 1345] 49 ( 3.5%) 1 ( 0.1%) 50 ( 2.1%) 0 0
Week 204 [Day 1429] 24 (