Drug Trials Snapshot: COSENTYX (secukinumab)
HOW TO USE THIS SNAPSHOT:
The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.
LIMITATIONS OF THIS SNAPSHOT:
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to the COSENTYX Package Insert for complete information.
COSENTYX (secukinumab)
Koe-SEN-tix
Novartis Pharmaceuticals Corporation
Approval date: January 21, 2015
DRUG TRIALS SUMMARY:
What is the drug for?
COSENTYX is used to treat moderate to severe plaque psoriasis in adults who do not respond well to medication applied directly to the skin.
How do I use this drug?
COSENTYX is an injection given once a week for five consecutive weeks followed by an injection once every four weeks.
What are the benefits of this drug?
Clinical trials showed that COSENTYX was better than a placebo in improving symptoms of plaque psoriasis and sustaining the improvement through a year of treatment.
What are the benefits of this drug (results of trials used to assess efficacy)?
The co-primary endpoints of the pivotal trials were:
- The proportion of patients achieving a minimum 75% reduction in the Psoriasis Area and Severity Index (PASI) score
- The proportion of patients scoring 0 or 1 at Week 12 on the Investigator’s Global Assessment (IGA)
The Table below summarizes clinical response rates in the two pivotal trials.
Table 5. Results of the Co-primary Efficacy Endpoints at Week 12
| Trial 1 | Trial 2 | ||||||
|---|---|---|---|---|---|---|---|
| COSENTYX 300 mg (N=245) |
COSENTYX 150 mg (N=245) |
Placebo (N=248) |
COSENTYX 300 mg (N=327) |
COSENTYX 150 mg (N=327) |
Placebo (N=326) |
Biologic Active Comparator (N=326) |
|
| Co-primary endpoints | |||||||
| IGA of clear or almost clear | 160 (65%) | 125 (51%) | 6 (2%) | 202 (62%) | 167 (51%) | 9 (3%) | 88 (27%) |
| PASI 75 Response | 200 (82%) | 174 (71%) | 11 (4%) | 249 (76%) | 219 (67%) | 16 (5%) | 142 (44%) |
Source: FDA Clinical Review, Table 6
Were there any differences in how well the drug worked in clinical trials among sex, race and age?
Subgroup analyses were conducted for sex, race, and age.
- Sex: COSENTYX was similarly effective in men and women.
- Race: The number of non-white patients was limited; therefore, differences in response between white and non-white patients could not be determined.
- Age: The number of patients above 65 years of age was limited; therefore, differences in response between patients above and below 65 years of age could not be determined.
Were there any differences in how well the drug worked in clinical trials among sex, race, and age?
Table 6. IGA Success by Gender, Age, Race, and Weight for the Pivotal Trials (Trial 1 and Trial 2)
| Trial 1 | Trial 2 | |||||||
|---|---|---|---|---|---|---|---|---|
| COSENTYX | Placebo N=248 |
COSENTYX | Placebo N=326 |
Biologic active comparator N=326 |
||||
| 300 mg N=245 |
150 mg N=245 |
300 mg N=327 |
150 mg N=327 |
|||||
| Sex | ||||||||
|
Female |
51/76 (67%) |
43/77 (56%) |
5/76 (7%) |
60/103 (58%) |
58/91 (64%) |
2/89 (2%) |
25/94 (26%) |
|
|
Male |
109/169 (65%) |
82/168 (49%) |
1/172 (0.6%) |
142/224 (63%) |
109/236 (46%) |
7/237 (3%) |
63/232 (27%) |
|
| Age | ||||||||
|
<> |
149/228 (65%) |
112/225 (59%) |
6/229 (3%) |
194/311 (62%) |
161/310 (52%) |
9/311 (3%) |
85/313 (27%) |
|
|
≥65 |
11/17 (65%) |
13/20 (65%) |
0/19 (0%) |
8/16 (50%) |
6/17 (35%) |
0/15 (0%) |
3/13 (23%) |
|
| Race | ||||||||
|
Asian |
33/52 (63%) |
31/54 (57%) |
1/47 (2%) |
33/73 (45%) |
27/72 (38%) |
2/72 (3%) |
13/74 (17%) |
|
|
Black |
2/4 | 3/5 | 0/9 | 2/2 | 3/3 | 0/3 | - | |
|
Caucasian |
110/171 (64%) |
82/171 (48%) |
3/176 (2%) |
143/224 (64%) |
118/219 (54%) |
5/217 (2%) |
60/219 (27%) |
|
|
Native |
5/7 | 2/5 | 0/3 | 18/22 (81%) |
18/28 (64%) |
2/25 (8%) |
12/27 (44%) |
|
|
Pacific Islander |
2/3 | 1/1 | - | 1/1 | - | 0/1 | 0/1 | |
|
Other |
6/6 | 6/9 | 2/13 | 5/5 | 1/5 | 0/5 | 3/4 | |
|
Unknown |
2/2 | - | - | - | - | 0/2 | 0/1 | |
Extracted from FDA Statistical Review, Table 39
What are the possible side effects?
The most common side effects were common cold, diarrhea, and upper respiratory tract infection.
COSENTYX is a medicine that affects the immune system; therefore, it can decrease a patient’s ability to fight infections and lead to an increased risk of infections.
Before a patient is started on COSENTYX, patients should first be evaluated for tuberculosis infection.
In patients with Crohn’s disease, “flare-ups” can happen with COSENTYX, and can sometimes be serious. There were cases of serious allergic reactions in some patients treated with COSENTYX in the clinical trials. Also, the cap of the COSENTYX pen which delivers the drug and the COSENTYX prefilled syringe both contain natural rubber latex which may cause an allergic reaction in latex-sensitive individuals.
What are the possible side effects (results of trials used to assess safety)?
The most common adverse events (AEs) in patients treated with any dose of COSENTYX were nasopharyngitis (12%), headache (6%), and diarrhea (3%). The table below summarizes the AEs that occurred at a rate of at least 1% and at a higher rate in the COSENTYX groups compared to the placebo group during the 12-week placebo-controlled period used for the safety analysis.
Table 7. Most frequent (≥2% in any group) AEs by preferred term up to 12 weeks
| Adverse Reaction | COSENTYX | Placebo N=694 n (%) |
|
|---|---|---|---|
| 150 mg N=692 n (%) |
300 mg N=690 n (%) |
||
| Nasopharyngitis | 85 (12.3) | 79 (11.4) | 60 (8.6) |
| Headache | 38 (5.5) | 45 (6.5) | 36 (5.2) |
| Diarrhea | 18 (2.6) | 28 (4.1) | 10 (1.4) |
| Pruritus | 21 (3.0) | 23 (3.3) | 18 (2.6) |
| Upper respiratory tract infection | 22 (3.2) | 17 (2.5) | 5 (0.7) |
| Oropharyngeal pain | 17 (2.5) | 15 (2.2) | 12 (1.7) |
| Arthralgia | 20 (2.9) | 9 (1.3) | 17 (2.4) |
| Hypertension | 22 (3.2) | 7 (1.0) | 12 (1.7) |
| Cough | 9 (1.3) | 19 (2.8) | 9 (1.3) |
| Back pain | 12 (1.7) | 14 (2.0) | 10 (1.4) |
| Nausea | 12 (1.7) | 14 (2.0) | 14 (2.0) |
| Fatigue | 14 (2.0) | 10 (1.4) | 7 (1.0) |
| Psoriasis | 10 (1.4) | 4 (0.6) | 20 (2.9) |
| Pyrexia | 4 (0.6) | 10 (1.4) | 6 (0.9) |
| Injection site erythema | 0 (0.0) | 1 (0.1) | 0 (0.0) |
Extracted from FDA Statistical Review, Table 39
Were there any differences in side effects among sex, race and age?
Subgroup analyses were conducted for sex, race, and age subgroups.
- Sex: The risk of side effects was similar in men and women.
- Race: The number of patients in the non-white subgroup was limited. Therefore, differences among races could not be detected.
- Age: The risk of side effects was similar in patients below and above age 65 years.
Were there any differences in side effects of the clinical trials among sex, race, and age?
The tables below summarize the incidence of adverse events by demographic subgroup for the entire 52-week treatment period. The results for the 12-week placebo-controlled period were consistent with these analyses.
Table 9. Exposure-adjusted incidence of adverse events by gender (52-week treatment period) most frequent SOCs
| Gender subgroup | COSENTYX 150 mg n (IR) |
COSENTYX 300 mg n (IR) |
COSENTYX dose n (IR) |
Placebo n (IR) |
Biologic Active Comparator n (IR) |
|---|---|---|---|---|---|
| Primary system organ class | |||||
| Male – N | 958 | 974 | 2406 | 552 | 229 |
|
Any AE |
702 (214.8) | 750 (226.1) | 1809 (236.6) | 279 (338.7) | 171 (209.9) |
|
Infections and infestations |
413 (75.5) | 469 (84.3) | 1084 (83.3) | 112 (95.1) | 116 (85.1) |
|
Skin and subcutaneous tissue disorders |
154 (22.1) | 192 (27.1) | 457 (27.5) | 59 (46.4) | 32 (17.0) |
|
Gastrointestinal disorders |
155 (22.2) | 163 (22.4) | 398 (23.5) | 47 (36.7) | 42 (22.8) |
| Female – N | 437 | 436 | 1024 | 241 | 94 |
|
Any AE |
364 (309.6) | 341 (261.6) | 828 (297.7) | 134 (382.6) | 82 (364.9) |
|
Infections and infestations |
232 (104.4) | 232 (106.2) | 544 (109.1) | 58 (111.3) | 54 (108.5) |
|
Skin and subcutaneous tissue disorders |
116 (40.8) | 95 (31.4) | 259 (39.0) | 20 (33.3) | 29 (45.2) |
|
Gastrointestinal disorders |
98 (32.7) | 99 (33.3) | 223 (32.7) | 30 (51.7) | 26 (39.2) |
IR=incidence rate per 100 patient-years
Source: FDA Clinical Review,Table 46
Table 10. Exposure-adjusted incidence of adverse events by race (52-week treatment period) most frequent SOCs
Race subgroup |
COSENTYX 150 mg n (IR) |
COSENTYX 300 mg n (IR) |
COSENTYX dose n (IR) |
Placebo n (IR) |
Biologic Active Comparator n (IR) |
|---|---|---|---|---|---|
| Primary system organ class | |||||
| Caucasian – N | 1001 | 1017 | 2558 | 593 | 216 |
|
Any AE |
757 (239.8) | 795 (256.8) | 1966 (265.4) | 317 (383.6) | 179 (291.4) |
|
Infections and infestations |
486 (92.8) | 540 (103.6) | 1274 (101.1) | 140 (119.2) | 131 (115.5) |
|
Skin and subcutaneous tissue disorders |
167 (23.7) | 190 (26.3) | 496 (28.9) | 53 (39.7) | 41 (24.4) |
|
Gastrointestinal disorders |
189 (27.3) | 202 (28.5) | 487 (28.5) | 61 (47.0) | 50 (30.2) |
| Black – N | 27 | 20 | 51 | 15 | 0 |
|
Any AE |
21 (253.3) | 13 (139.4) | 37 (205.5) | 5 (194.5) | - |
|
Infections and infestations |
6 (34.1) | 2 (14.3) | 9 (27.1) | 2 (62.7) | - |
|
Skin and subcutaneous tissue disorders |
8 (50.7) | 2 (14.0) | 11 (34.3) | 2 (53.4) | - |
|
Gastrointestinal disorders |
2 (10.0) | 1 (6.9) | 3 (8.2) | 0 (0.0) | - |
| Asian – N | 292 | 296 | 664 | 134 | 74 |
|
Any AE |
228 (226.2) | 221 (187.8) | 508 (213.6) | 60 (249.0) | 47 (140.9) |
|
Infections and infestations |
117 (63.4) | 115 (58.1) | 262 (62.4) | 20 (58.9) | 25 (48.3) |
|
Skin and subcutaneous tissue disorders |
81 (39.8) | 75 (34.3) | 175 (37.6) | 18 (53.0) | 15 (26.2) |
|
Gastrointestinal disorders |
41 (17.5) | 42 (17.2) | 93 (17.7) | 9 (24.9) | 11 (18.9) |
| Native American – N | 47 | 44 | 92 | 28 | 27 |
|
Any AE |
39 (335.9) | 32 (180.3) | 72 (242.7) | 13 (289.5) | 22 (288.6) |
|
Infections and infestations |
22 (78.1) | 23 (85.3) | 46 (83.0) | 1 (14.2) | 9 (49.3) |
|
Skin and subcutaneous tissue disorders |
10 (28.9) | 10 (28.6) | 20 (28.6) | 3 (44.0) | 4 (17.8) |
|
Gastrointestinal disorders |
13 (40.5) | 10 (29.0) | 23 (34.3) | 5 (74.1) | 6 (28.2) |
| Pacific islander – N | 2 | 5 | 7 | 2 | 1 |
|
Any AE |
1 (89.7) | 4 (172.1) | 5 (145.4) | 2 (7305.0) | 1 (652.2) |
|
Infections and infestations |
1 (72.0) | 3 (93.2) | 4 (86.8) | 0 (0.0) | 1 (652.2) |
|
Skin and subcutaneous tissue disorders |
0 (0.0) | 3 (118.6) | 3 (69.9) | 1 (405.8) | 0 (0.0) |
|
Gastrointestinal disorders |
1 (89.7) | 1 (26.0) | 2 (40.3) | 0 (0.0) | 0 (0.0) |
| Other – N | 22 | 24 | 50 | 19 | 4 |
|
Any AE |
17 (305.3) | 22 (481.5) | 42 (375.2) | 15 (450.2) | 3 (225.0) |
|
Infections and infestations |
10 (89.8) | 14 (136.2) | 26 (114.7) | 6 (80.8) | 3 (119.0) |
|
Skin and subcutaneous tissue disorders |
3 (18.8) | 5 (31.9) | 8 (23.6) | 2 (23.5) | 1 (32.1) |
|
Gastrointestinal disorders |
5 (36.2) | 5 (29.2) | 10 (30.2) | 2 (23.0) | 1 (30.6) |
IR=incidence rate per 100 patient-years
Source: FDA Clinical Review, Table 48
Table 11. Exposure-adjusted incidence of adverse events by age (52-week treatment period) most frequent SOCs
Age subgroup |
COSENTYX 150 mg n (IR) |
COSENTYX 300 mg n (IR) |
COSENTYX dose n (IR) |
Placebo n (IR) |
Biologic Active Comparator n (IR) |
|---|---|---|---|---|---|
| Primary system organ class | |||||
| 65 yr – N | 1293 | 1311 | 3200 | 744 | 305 |
|
Any AE |
991 (242.4) | 1014 (237.5) | 2462 (255.0) | 389 (354.0) | 238 (239.7) |
|
Infections and infestations |
604 (84.9) | 659 (91.9) | 1535 (91.9) | 163 (102.1) | 162 (91.3) |
|
Skin and subcutaneous tissue disorders |
253 (27.8) | 258 (27.3) | 659 (30.3) | 77 (43.9) | 56 (23.4) |
|
Gastrointestinal disorders |
234 (25.1) | 248 (26.0) | 583 (26.2) | 74 (42.4) | 63 (26.3) |
| ≥ 65 yr – N | 102 | 99 | 230 | 49 | 18 |
|
Any AE |
75 (211.4) | 77 (219.5) | 175 (225.8) | 24 (320.2) | 15 (322.9) |
|
Infections and infestations |
41 (71.3) | 42 (72.4) | 93 (71.4) | 7 (67.8) | 8 (92.2) |
|
Skin and subcutaneous tissue disorders |
17 (24.4) | 29 (44.6) | 57 (38.0) | 2 (17.1) | 5 (36.6) |
|
Gastrointestinal disorders |
19 (28.6) | 14 (20.0) | 38 (24.3) | 3 (26.4) | 5 (46.7) |
| ≥ 75 yr – N | 15 | 15 | 32 | 10 | 3 |
|
Any AE |
11 (245.1) | 12 (313.5) | 25 (295.5) | 6 (437.4) | 2 (177.7) |
|
Infections and infestations |
6 (84.5) | 5 (64.7) | 12 (78.4) | 1 (44.2) | 2 (177.7) |
|
Skin and subcutaneous tissue disorders |
5 (57.7) | 2 (21.8) | 8 (42.0) | 2 (95.1) | 0 (0.0) |
|
Gastrointestinal disorders |
2 (20.9) | 4 (51.5) | 6 (31.8) | 0 (0.0) | 0 (0.0) |
IR=incidence rate per 100 patient-years
Source: FDA Clinical Review, Table 47
WHO WAS IN THE STUDIES?
Who participated in the clinical trials?
The FDA approved COSENTYX on evidence mainly from two clinical trials with a total of 2,044 adults who were diagnosed with plaque psoriasis that involved at least 10% of their body surface. The studies were conducted in North America, Central and South America, Europe, Asia, Central and South America, Africa, and Australia.
Figure 1 summarizes how many men and women were enrolled in the clinical trials used to evaluate efficacy.
Figure 1. Baseline Demographics by Sex
Source: Adapted from FDA Statistical Review, Table 8
Figure 2 and Table 1 summarize the percentage of patients by race enrolled in the clinical trials used to evaluate efficacy.
Figure 2. Baseline Demographics by Race
Source: Adapted from FDA Statistical Review, Table 8
Table 1. Demographics of Safety Trials by Race
| Race | Number of Patients | Percentage |
|---|---|---|
| Caucasian | 1397 | 68.4% |
| Black | 27 | 1.3% |
| Asian | 443 | 21.7% |
| Native American | 117 | 5.7% |
| Pacific Islander | 7 | 0.3% |
| Unknown | 5 | 0.2% |
| Other | 47 | 2.3% |
Source: Adapted from FDA Statistical Review, Table 8
Who participated in the study?
COSENTYX was evaluated in two clinical trials, referred to as Trial 1 and Trial 2, for the treatment of moderate to severe plaque psoriasis in adult patients. The trial population for Trial 1 included 738 patients from 86 sites in 12 countries located in North America, Central and South America, Europe, and Asia. The population for Trial 2 included 1,306 patients from 154 sites in 23 countries located in North America (including the United States), Central and South America, Europe, Asia, Africa, and Australia. Patients in Trial 1 were randomized to receive either a lower dose of COSENTYX (150 mg), a higher dose of COSENTYX (300 mg), or a placebo. Patients in Trial 2 were randomized to receive either low-dose secukinumab, high-dose secukinumab, placebo, or a biologic active control.
Table 3. Baseline Demographics for the Pivotal Trials
| Trial 1 | Trial 2 | ||||||
|---|---|---|---|---|---|---|---|
| COSENTYX 300 mg N=245 |
COSENTYX 150 mg N=245 |
Placebo N=248 |
COSENTYX 300 mg N=327 |
COSENTYX 150 mg N=327 |
Placebo N=326 |
Biologic Active Control N=326 |
|
| Sex | |||||||
|
Female |
76 (31%) | 77 (31%) | 76 (31%) | 103 (32%) | 91 (28%) | 89 (27%) | 94 (29%) |
|
Male |
169 (69%) | 168 (69%) | 172 (69%) | 224 (69%) | 236 (72%) | 237 (73%) | 232 (71%) |
| Age | |||||||
|
Mean |
45 | 45 | 45 | 45 | 45 | 44 | 44 |
|
SD |
14 | 13 | 13 | 13 | 13 | 13 | 13 |
|
Range |
19-76 | 18-83 | 19-80 | 20-79 | 18-79 | 18-82 | 18-79 |
|
Median |
45 | 45 | 45 | 45 | 45 | 44 | 44 |
|
<> |
228 (93%) | 223 (91%) | 229 (92%) | 305 (93%) | 304 (93%) | 311 (95%) | 308 (94%) |
|
<65 |
17 (7%) | 22 (9%) | 19 (8%) | 22 (7%) | 23 (7%) | 15 (5%) | 18 (6%) |
| Race | |||||||
|
Asian |
52 (21%) | 54 (22%) | 46 (19%) | 73 (22%) | 72 (22%) | 72 (22%) | 74 (23%) |
|
Black |
4 (2%) | 5 (2%) | 10 (4%) | 2 (1%) | 3 (1%) | 3 (1%) | 0 (0%) |
|
Caucasian |
171 (70%) | 171 (70%) | 176 (71%) | 224 (69%) | 219 (67%) | 217 (67%) | 219 (67%) |
|
Native |
7 (3%) | 5 (2%) | 3 (1%) | 22 (7%) | 28 (9%) | 25 (8%) | 27 (8%) |
|
Pacific Islander |
3 (1%) | 1 (0.4%) | 0 (0%) | 1 (0.3%) | 0 (0%) | 1 (0.3%) | 1 (0.3%) |
|
Other |
6 (2%) | 9 (4%) | 13 (5%) | 5 (2%) | 5 (2%) | 5 (2%) | 4 (1%) |
|
Unknown |
2 (1%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 2 (0.6%) | 1 (0.3%) |
Extracted from FDA Statistical Review, Table 8
How was the study designed?
COSENTYX was approved by the FDA based primarily on two clinical trials with a total of 2,044 patients. Patients were randomly assigned to one of three treatment groups: one-third of patients were given a higher dose of COSENTYX, one-third was given a lower dose of COSENTYX, and one-third was given a placebo. Neither the patients nor the health care professionals administering the drug knew which patients were in which group until after the drug trial was complete. Patients were evaluated for improvement of psoriasis after 12 weeks.
Safety evaluations of COSENTYX were based on four trials with a total of 2399 patients. One-third was given high-dose COSENTYX, one-third was given low-dose COSENTYX, and one-third was given low-dose COSENTYX.
Figure 3 summarizes how many men and women were enrolled in the clinical trials used to assess safety.
Figure 3. Demographics of Safety Trials by Sex
Extracted from FDA Clinical Review, Table 17
Figure 4 and Table 2 summarize the percentage of patients by race enrolled in the clinical trials used to assess safety.
Figure 4. Demographics of Safety Trials by Race
Extracted from FDA Clinical Review, Table 17
Table 2. Demographics of Safety Trials by Race
| Race | Number of Patients | Percentage |
|---|---|---|
| Caucasian | 1730 | 72.1% |
| Black | 35 | 1.5% |
| Asian | 453 | 18.9% |
| Native American | 117 | 4.9% |
| Pacific Islander | 7 | 0.3% |
| Unknown | 6 | 0.3% |
| Other | 51 | 2.1% |
Source: Adapted from FDA Statistical Review, Table 8
How was the study designed?
Efficacy of COSENTYX was evaluated in one randomized, placebo-controlled Phase 3 clinical trial (Trial 1) and one randomized, placebo-controlled and active-controlled trial (Trial 2). Clinical response was defined as both of the following:
- The proportion of patients achieving a minimum 75% reduction in the Psoriasis Area and Severity Index (PASI) score
- The proportion of patients scoring 0 or 1 at Week 12 on the Investigator’s Global Assessment (IGA)
For Trial 2, low- and high-dose COSENTYX were additionally compared to the active-comparator for the same co-primary endpoints.
COSENTYX was primarily evaluated for safety in four randomized, placebo-controlled studies (Trials 1, 2, 3, and 4) through Week 12. Table 4 below provides a summary of the demographic data for the safety population.
Table 4. Demographics of subjects in Trials 1, 2, 3, and 4 through Week 12
| Demographic variable | COSENTYX 150 mg N=692 |
COSENTYX 300 mg N=690 |
Placebo N=694 |
Biologic Active Control N=323 |
Total N=2399 |
|---|---|---|---|---|---|
| Age group in years, n (%) | |||||
|
<65 |
634 (91.6) | 642 (93.0) | 651 (93.8) | 305 (94.4) | 2232 (93) |
|
≥ 65 |
58 (8.4) | 48 (7.0) | 43 (6.2) | 18 (5.6) | 167 (7) |
|
≥ 75 |
10 (1.4) | 6 (0.9) | 10 (1.4) | 3 (0.9) | 29 (1.2) |
| Age (years) | |||||
|
n |
692 | 690 | 694 | 323 | 2399 |
|
Mean |
45.1 | 44.9 | 44.7 | 43.8 | 44.8 |
|
SD |
13.38 | 13.32 | 12.79 | 12.99 | 13.1 |
|
Median |
45 | 45 | 45 | 44 | 45 |
|
Min - Max |
18 - 83 | 18 - 83 | 18 - 82 | 18 - 79 | 18 - 83 |
|
Sex, n (%) |
|||||
|
Female |
207 (29.9) | 214 (31) | 208 (30) | 94 (29.1) | 723 (30.1) |
|
Male |
485 (70.1) | 476 (69) | 486 (70.0) | 229 (70.9) | 1676 (69.9) |
| Race, n (%) | |||||
|
Caucasian |
499 (72.1) | 504 (73) | 511 (73.6) | 216 (66.9) | 1730 (72.1) |
|
Black |
13 (1.9) | 9 (1.3) | 13 (1.9) | 0 (0.0) | 35 (1.5) |
|
Asian |
129 (18.6) | 129 (18.7) | 121 (17.4) | 74 (22.9) | 453 (18.9) |
|
Native American |
33 (4.8) | 29 (4.2) | 28 (4.0) | 27 (8.4) | 117 (4.9) |
|
Pacific Islander |
1 (0.1) | 4 (0.6) | 1 (0.1) | 1 (0.3) | 7 (0.3) |
|
Unknown |
1 (0.1) | 2 (0.3) | 2 (0.3) | 1 (0.3) | 6 (0.3) |
|
Other |
16 (2.3) | 13 (1.9) | 18 (2.6) | 4 (1.2) | 51 (2.1) |
Extracted from FDA Clinical Review, Table 17
What are the results of the efficacy study?
Approximately two-thirds of patients receiving the higher dose and approximately one-half of patients treated with the lower dose of COSENTYX achieved clear skin or almost clear skin during the first 12 weeks of treatment and maintained the response for a year.
What are the results of the trials used to assess safety?
The most common side effects that were seen more often than placebo were common cold, diarrhea, and upper respiratory tract infection.
Some infections were seen more frequently in patients treated with COSENTYX compared to those receiving placebo (28.7% compared to 18.9%). In patients with Crohn’s disease, worsening of the Crohn’s disease was observed in patients treated with COSENTYX. Allergic reactions, some serious, were seen in patients treated with COSENTYX.
GLOSSARY
CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.