Drug Trials Snapshots: ICOTYDE
HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic 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 healthcare provider about the benefits and risks of a drug.
Some of the information in this Snapshot is for presentation purposes and does not represent the approved conditions of use of this drug. Refer to the ICOTYDE Prescribing Information for all the approved conditions of use of this drug (e.g., indication(s), population(s), dosing regimen(s), safety information).
Snapshots are limited to the information available at the time of the original approval of the drug and do not provide information on who participated in clinical trials that supported later approvals for additional uses of the drug (if applicable).
ICOTYDE (icotrokinra)
(ai-koh-tide)
Janssen Biotech
Original Approval Date: March 17, 2026
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
ICOTYDE is an interleukin-23 (IL-23) receptor antagonist used for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg and who are candidates for systemic therapy or phototherapy.
How is this drug used?
ICOTYDE is a tablet that is taken orally once a day.
Who participated in the clinical trials?
The FDA approved ICOTYDE based on evidence from four clinical trials of 2,500 subjects with moderate-to-severe plaque psoriasis who were eligible for systemic therapy or phototherapy. The trials were conducted at 496 sites in 17 countries.
How were the trials designed?
The benefits and side effects of ICOTYDE were evaluated in four clinical trials. The trials enrolled 2,500 participants in the efficacy and safety trials. Each trial was randomized, double-blind, and placebo-controlled with efficacy assessment at Week 16.
Trials PSO-1 (NCT06143878) and PSO-2 (NCT06220604) enrolled adult patients and included treatment arms for ICOTYDE, placebo, and an active control.
Trial PSO-3 (NCT06095115) enrolled patients 12 years of age and older and included treatment arms of ICOTYDE and placebo.
Trial PSO-4 (NCT06095102) included treatment arms of ICOTYDE and placebo and enrolled patients 12 years of age and older who had moderate or severe plaque psoriasis of the scalp, genital area, or hands and/or feet and had failed to respond to at least one topical therapy for the treatment of plaque psoriasis.
How were the trials designed?
Trial PSO-1 and PSO-2 were randomized, multicenter, double-blind, placebo-controlled and active comparator-controlled studies in adult patients with moderate-to-severe plaque psoriasis. Patients had to have an Investigator Global Assessment (IGA) score ≥3, a Psoriasis Area and Severity Index (PASI) score ≥12, and a body surface area (BSA) involvement ≥10%. The co-primary efficacy endpoints were:
- IGA 0/1 response (defined as IGA score of 0 [cleared] or 1 [minimal] with at least 2-grade improvement from baseline); and
- At least a 90% improvement in PASI score from baseline (PASI-90).
Trial PSO-3 was a randomized, multicenter, double-blind, placebo-controlled study in patients ≥12 years of age with moderate-to-severe plaque psoriasis. The co-primary efficacy endpoints were the same as those for Trials PSO-1 and PSO-2.
Trial PSO-4 was a randomized, multicenter, double-blind, placebo-controlled study in patients 12 years of age and older who had failed to respond to at least one topical therapy for the treatment of plaque psoriasis and had moderate or severe plaque psoriasis of the scalp, genital area, or hands and/or feet. Patients had to have a confirmation of plaque psoriasis in areas excluding scalp, genital, hands and feet and a BSA involvement ≥1%, and an overall IGA score ≥2. Additionally, patients had to have at least one of the following baseline conditions: Scalp Specific IGA (ss-IGA) score ≥3 (at least moderate plaque psoriasis of the scalp), and/or static Physician’s Global Assessment of Genitalia (sPGA-G) score ≥3 (at least moderate plaque psoriasis of the genital area), and/or Physician’s Global Assessment of Hands and/or Feet (hf-PGA) score ≥3 (at least moderate plaque psoriasis of the hands and/or feet). The primary efficacy endpoint was IGA 0/1 response.
DEMOGRAPHICS SNAPSHOT
The primary efficacy population for this application included 2,500 subjects with moderate-to-severe plaque psoriasis who were eligible for systemic therapy or phototherapy.
Figure 1 summarizes how many male and female subjects were enrolled in the efficacy population in the clinical trials used to evaluate the safety and efficacy of ICOTYDE.
Figure 1. Baseline Demographics by Sex, Efficacy Population
Source: Adapted from FDA Review
Figure 2 summarizes the percentage of subjects by race in the efficacy population that enrolled in the clinical trials used to evaluate the safety and efficacy of ICOTYDE.
Figure 2. Baseline Demographics by Race, Efficacy Population
Source: Adapted from FDA Review
* Other includes not reported, unknown, other, and multiple race subjects.
Figure 3 summarizes the percentage of subjects by age in the efficacy population that enrolled in the clinical trials used to evaluate the safety and efficacy of ICOTYDE.
Figure 3. Baseline Demographics by Age, Efficacy Population
Source: Adapted from FDA Review
Figure 4 summarizes the percentage of subjects by ethnicity in the efficacy population that enrolled in the clinical trial used to evaluate the safety and efficacy of ICOTYDE.
Figure 4. Baseline Demographics by Ethnicity, Efficacy Population
Source: Adapted from FDA Review
Who participated in the trials?
Table 1 through Table 4 summarize demographics and baseline clinical characteristics in the efficacy population that enrolled in the clinical trials used to evaluate the safety and efficacy of ICOTYDE.
Table 1. Demographics, Efficacy Population, Trial PSO-1
| Characteristic | ICOTYDE N=311 n (%) | Placebo N=156 n (%) | Deucravacitinib N=307 n (%) | Total N=774 n (%) |
|---|---|---|---|---|
| Sex | ||||
| Female | 88 (28.3) | 51 (32.7) | 107 (34.9) | 246 (31.8) |
| Male | 223 (71.7) | 105 (67.3) | 200 (65.1) | 528 (68.2) |
| Age, years | ||||
| 18 to 44 | 139 (44.7) | 69 (44.2) | 136 (44.3) | 344 (44.6) |
| 45 to 64 | 140 (45.0) | 69 (44.2) | 137 (44.6) | 346 (44.7) |
| ≥65 | 32 (10.3) | 18 (11.5) | 34 (11.1) | 84 (10.9) |
| Race | ||||
| American Indian or Alaska Native | 1 (0.3) | 1 (0.6) | 1 (0.3) | 3 (0.4) |
| Asian | 69 (22.2) | 34 (21.8) | 77 (25.1) | 180 (23.3) |
| Black or African American | 4 (1.3) | 3 (1.9) | 4 (1.3) | 11 (1.4) |
| Native Hawaiian or other Pacific Islander | 2 (0.6) | 0 (0.0) | 0 (0.0) | 2 (0.3) |
| Not reported | 2 (0.6) | 0 (0.0) | 3 (1.0) | 5 (0.6) |
| Unknown | 2 (0.6) | 0 (0.0) | 1 (0.3) | 3 (0.4) |
| White | 231 (74.3) | 118 (75.6) | 221 (72.0) | 570 (73.6) |
| Ethnicity | ||||
| Hispanic or Latino | 58 (18.6) | 25 (16.0) | 49 (16.0) | 132 (17.1) |
| Not Hispanic or Latino | 250 (80.4) | 129 (82.7) | 257 (83.7) | 636 (82.2) |
| Not reported | 2 (0.6) | 2 (1.3) | 0 (0.0) | 4 (0.5) |
| Unknown | 1 (0.3) | 0 (0.0) | 1 (0.3) | 2 (0.3) |
Source: Adapted from FDA Review
Abbreviations: N, number of subjects in treatment group; n, number of subjects with given characteristic; SD, standard deviation
Table 2. Demographics, Efficacy Population, Trial PSO-2
| Characteristic | ICOTYDE N=322 n (%) | Placebo N=82 n (%) | Deucravacitinib N=327 n (%) | Total N=731 n (%) |
|---|---|---|---|---|
| Sex | ||||
| Female | 104 (32.3) | 27 (32.9) | 104 (31.8) | 235 (32.1) |
| Male | 218 (67.7) | 55 (67.1) | 223 (68.2) | 496 (67.9) |
| Age, years | ||||
| 18 to 44 | 158 (49.1) | 36 (43.9) | 156 (47.7) | 350 (47.9) |
| 45 to 64 | 131 (40.7) | 36 (43.9) | 140 (42.8) | 307 (42.0) |
| ≥65 | 33 (10.2) | 10 (12.2) | 31 (9.5) | 74 (10.1) |
| Race | ||||
| American Indian or Alaska Native | 1 (0.3) | 0 (0.0) | 1 (0.3) | 2 (0.3) |
| Asian | 34 (10.6) | 15 (18.3) | 40 (12.2) | 89 (12.2) |
| Black or African American | 9 (2.8) | 2 (2.4) | 11 (3.4) | 22 (3.0) |
| Multiple | 1 (0.3) | 0 (0.0) | 2 (0.6) | 3 (0.4) |
| Native Hawaiian or other Pacific Islander | 2 (0.6) | 0 (0.0) | 3 (0.9) | 5 (0.7) |
| Not reported | 1 (0.3) | 0 (0.0) | 4 (1.2) | 5 (0.7) |
| Unknown | 0 (0.0) | 0 (0.0) | 1 (0.3) | 1 (0.1) |
| White | 274 (85.1) | 65 (79.3) | 265 (81.0) | 604 (82.6) |
| Ethnicity | ||||
| Hispanic or Latino | 42 (13.0) | 12 (14.6) | 48 (14.7) | 102 (14.0) |
| Not Hispanic or Latino | 279 (86.6) | 70 (85.4) | 279 (85.3) | 628 (85.9) |
| Unknown | 1 (0.3) | 0 (0.0) | 0 (0.0) | 1 (0.1) |
Source: Adapted from FDA Review
Abbreviations: N, number of subjects in treatment group; n, number of subjects with given characteristic; SD, standard deviation
Table 3. Demographics, Efficacy Population, Trial PSO-3
| Characteristic | ICOTYDE N=456 n (%) | Placebo N=228 n (%) | Total N=684 n (%) |
|---|---|---|---|
| Sex | |||
| Female | 165 (36.2) | 72 (31.6) | 237 (34.6) |
| Male | 291 (63.8) | 156 (68.4) | 447 (65.4) |
| Age, years | |||
| 12 to 17 | 44 (9.6) | 22 (9.6) | 66 (9.6) |
| 18 to 44 | 208 (45.6) | 92 (40.4) | 300 (43.9) |
| 45 to 64 | 164 (36.0) | 89 (39.0) | 253 (37.0) |
| ≥65 | 40 (8.8) | 25 (11.0) | 65 (9.5) |
| Race | |||
| American Indian or Alaska Native | 0 (0.0) | 1 (0.4) | 1 (0.1) |
| Asian | 110 (24.1) | 57 (25.0) | 167 (24.4) |
| Black or African American | 6 (1.3) | 2 (0.9) | 8 (1.2) |
| Multiple | 1 (0.2) | 0 (0.0) | 1 (0.1) |
| Native Hawaiian or other Pacific Islander | 2 (0.4) | 0 (0.0) | 2 (0.3) |
| Not reported | 5 (1.1) | 2 (0.9) | 7 (1.0) |
| Other | 3 (0.7) | 1 (0.4) | 4 (0.6) |
| White | 329 (72.1) | 165 (72.4) | 494 (72.2) |
| Ethnicity | |||
| Hispanic or Latino | 61 (13.4) | 27 (11.8) | 88 (12.9) |
| Not Hispanic or Latino | 386 (84.6) | 199 (87.3) | 585 (85.5) |
| Not reported | 3 (0.7) | 1 (0.4) | 4 (0.6) |
| Unknown | 6 (1.3) | 1 (0.4) | 7 (1.0) |
Source: Adapted from FDA Review
Abbreviations: N, number of subjects in treatment group; n, number of subjects with given characteristic; SD, standard deviation
Table 4. Demographics, Efficacy Population, Trial PSO-4
| Characteristic | ICOTYDE N=208 n (%) | Placebo N=103 n (%) | Total N=311 n (%) |
|---|---|---|---|
| Sex | |||
| Female | 71 (34.1) | 40 (38.8) | 111 (35.7) |
| Male | 137 (65.9) | 63 (61.2) | 200 (64.3) |
| Age, years | |||
| 12 to 17 | 3 (1.4) | 3 (2.9) | 6 (1.9) |
| 18 to 44 | 100 (48.1) | 50 (48.5) | 150 (48.2) |
| 45 to 64 | 85 (40.9) | 45 (43.7) | 130 (41.8) |
| ≥65 | 20 (9.6) | 5 (4.9) | 25 (8.0) |
| Race | |||
| Asian | 41 (19.7) | 20 (19.4) | 61 (19.6) |
| Black or African American | 2 (1.0) | 0 (0.0) | 2 (0.6) |
| Multiple | 1 (0.5) | 0 (0.0) | 1 (0.3) |
| Not reported | 3 (1.4) | 1 (1.0) | 4 (1.3) |
| White | 161 (77.4) | 82 (79.6) | 243 (78.1) |
| Ethnicity | |||
| Hispanic or Latino | 16 (7.7) | 5 (4.9) | 21 (6.8) |
| Not Hispanic or Latino | 184 (88.5) | 96 (93.2) | 280 (90.0) |
| Not reported | 8 (3.8) | 2 (1.9) | 10 (3.2) |
Source: Adapted from FDA Review
Abbreviations: N, number of subjects in treatment group; n, number of subjects with given characteristic; SD, standard deviation
What are the benefits of this drug?
ICOTYDE helped alleviate the signs and symptoms of plaque psoriasis in adult and pediatric patients aged 12 years and older over a 16-week period.
What are the benefits of this drug (results of trials used to assess efficacy)?
Table 5 summarizes efficacy results in the clinical trials used to evaluate the safety and efficacy of ICOTYDE.
Table 5. Efficacy Results: IGA 0/1 Response1 and PASI-90 Response2 at Week 16, Efficacy Population, Trials PSO-1, PSO-2, PSO-3, and PSO-4
| Coprimary | Trial PSO-1 | Trial PSO-2 | Trial PSO-3 | Trial PSO-4 | ||||
|---|---|---|---|---|---|---|---|---|
| ICOTYDE N=311 | Placebo N=156 | ICOTYDE N=322 | Placebo N=82 | ICOTYDE N=456 | Placebo N=228 | ICOTYDE N=208 | Placebo N=103 | |
| IGA 0/1 (Week 16), % | 68.5 | 10.9 | 70.5 | 8.5 | 64.7 | 8.3 | 56.7 | 5.8 |
| Risk difference, % (95% CI) | 57.6 (49.9, 64.2) | 62.0 (52.9, 69.1) | 56.4 (50.4, 61.7) | 51.1 (42.1, 58.8) | ||||
| PASI-90 (Week 16), % | 55.0 | 3.8 | 57.1 | 1.2 | 49.6 | 4.4 | Not included | |
| Risk difference, % (95% CI) | 51.1 (44.5, 57.3) | 55.9 (48.5, 62.0) | 45.1 (39.6, 50.4) | Not included | ||||
Source: Adapted from FDA Review
1 IGA score of 0 [cleared] or 1 [minimal] with at least 2-grade improvement from baseline
2 At least a 90% improvement in PASI score from baseline
Abbreviations: CI, confidence interval; IGA, Investigator Global Assessment; N, number of subjects in treatment group; PASI, Psoriasis Area and Severity Index
Were there any differences in how well the drug worked in clinical trials among sex, race, age, and ethnicity groups?
- Sex: The effect of ICOTYDE was similar for males and females.
- Race: The effect of ICOTYDE was similar for patients who were White and Asian. The number of patients of other races was small; therefore, differences in how the drug worked among other races could not be determined.
- Age: The effect of ICOTYDE was similar for all age groups.
- Ethnicity: The effect of ICOTYDE was similar for patients who were Hispanic or Latino and patients who were not Hispanic or Latino.
Were there any differences in how well the drug worked in clinical trials among sex, race, age, and ethnicity groups?
Table 6 through Table 12 summarize the efficacy results by sex, race, age, and ethnicity in the clinical trials used to evaluate the safety and efficacy of ICOTYDE.
Table 6. Efficacy Results: IGA 0/1 Response1 at Week 16 by Subgroup, Efficacy Population, Trial PSO-1
| Subgroup | ICOTYDE n/Ns (%) | Placebo n/Ns (%) | Difference % (95% CI) |
|---|---|---|---|
| Overall | 213/311 (68) | 17/156 (11) | 58 (50, 64) |
| Sex | |||
| Female | 67/88 (76) | 5/51 (10) | 66 (52, 78) |
| Male | 146/223 (65) | 12/105 (11) | 54 (44, 62) |
| Age group, years | |||
| 18 to 44 | 106/139 (76) | 6/69 (9) | 68 (56, 76) |
| 45 to 64 | 82/140 (59) | 8/69 (12) | 47 (34, 57) |
| ≥65 | 25/32 (78) | 3/18 (17) | 62 (31, 80) |
| Race | |||
| American Indian or Alaska Native | 1/1 (100) | 0/1 (0) | NC |
| Asian | 45/69 (65) | 3/34 (9) | 56 (38, 70) |
| Black or African American | 2/4 (50) | 0/3 (0) | 50 (-30, 93) |
| Native Hawaiian or other Pacific Islander | 2/2 (100) | 0 | NC |
| White | 160/231 (69) | 14/118 (12) | 57 (48, 65) |
| Not reported | 1/2 (50) | 0 | NC |
| Unknown | 2/2 (100) | 0 | NC |
| Ethnicity | |||
| Hispanic or Latino | 42/58 (72) | 4/25 (16) | 56 (34, 72) |
| Not Hispanic or Latino | 170/250 (68) | 13/129 (10) | 58 (49, 65) |
| Not reported | 1/2 (50) | 0 | 50 (-61, 99) |
| Unknown | 0/1 (0) | 0 | NC |
Source: Adapted from FDA Review
1 IGA score of 0 [cleared] or 1 [minimal] with at least 2-grade improvement from baseline
Abbreviations: CI, confidence interval; IGA, Investigator Global Assessment; n, number of subjects with a response; NC, not calculated; NS, number of subjects in subgroup
Table 7. Efficacy Results: IGA 0/1 Response1 at Week 16 by Subgroup, Efficacy Population, Trial PSO-2
| Subgroup | ICOTYDE n/Ns (%) | Placebo n/Ns (%) | Difference % (95% CI) |
|---|---|---|---|
| Overall | 227/322 (70) | 7/82 (9) | 62 (52, 69) |
| Sex | |||
| Female | 72/104 (69) | 3/27 (11) | 58 (38, 71) |
| Male | 155/218 (71) | 4/55 (7) | 64 (52, 72) |
| Age group, years | |||
| 18 to 44 | 110/158 (70) | 5/36 (14) | 56 (38, 67) |
| 45 to 64 | 94/131 (72) | 1/36 (3) | 69 (56, 78) |
| ≥65 | 23/33 (70) | 1/10 (10) | 60 (19, 79) |
| Race | |||
| American Indian or Alaska Native | 0/1 (0) | 0 | NC |
| Asian | 25/34 (74) | 1/15 (7) | 67 (38, 84) |
| Black or African American | 5/9 (56) | 0 | 56 (-31, 86) |
| Multiple | 0/1 (0) | 0 | NC |
| Native Hawaiian or other Pacific Islander | 2/2 (100) | 0 | NC |
| Not reported | 1/1 (100) | 0 | NC |
| White | 194/274 (71) | 6/65 (9) | 62 (50, 69) |
| Ethnicity | |||
| Hispanic or Latino | 17/42 (40) | 3/12 (25) | 16 (-19, 41) |
| Not Hispanic or Latino | 209/279 (75) | 4/70 (6) | 69 (60, 76) |
| Not reported | 1/1 (100) | 0 | NC |
Source: Adapted from FDA Review
1 IGA score of 0 [cleared] or 1 [minimal] with at least 2-grade improvement from baseline
Abbreviations: CI, confidence interval; IGA, Investigator Global Assessment; n, number of subjects with a response; NC, not calculated; NS, number of subjects in subgroup
Table 8. Efficacy Results: IGA 0/1 Response1 at Week 16 by Subgroup, Efficacy Population, Trial PSO-3
| Subgroup | ICOTYDE n/Ns (%) | Placebo n/Ns (%) | Difference % (95% CI) |
|---|---|---|---|
| Overall | 295/456 (65) | 19/228 (8) | 56 (50, 62) |
| Sex | |||
| Female | 113/165 (68) | 10/72 (14) | 55 (42, 65) |
| Male | 182/292 (63) | 9/156 (6) | 57 (50, 63) |
| Age group, years | |||
| 12 to 17 | 37/44 (84) | 6/22 (27) | 57 (32, 76) |
| 18 to 44 | 129/208 (62) | 8/92 (9) | 53 (43, 62) |
| 45 to 64 | 100/164 (61) | 4/89 (4) | 56 (47, 65) |
| ≥65 | 29/40 (73) | 1/25 (4) | 68 (46, 82) |
| Race | |||
| American Indian or Alaska Native | 0 | 0/1 (0) | NC |
| Asian | 76/110 (69) | 4/57 (7) | 62 (49, 72) |
| Black or African American | 3/6 (50) | 0/2 (0) | 50 (-43, 88) |
| Native Hawaiian or other Pacific Islander | 1/2 (50) | 0 | NC |
| White | 209/329 (64) | 15/165 (9) | 54 (47, 61) |
| Not reported | 4/5 (80) | 0/2 (0) | 80 (-14, 100) |
| Unknown | 2/3 (67) | 0/1 (0) | 67 (-59, 99) |
| Multiple | 0/1 (0) | 0 | NC |
| Ethnicity | |||
| Hispanic or Latino | 36/61 (59) | 3/27 (11) | 48 (26, 63) |
| Not Hispanic or Latino | 253/386 (66) | 16/199 (8) | 58 (51, 63) |
| Not reported | 3/3 (100) | 0/1 (0) | NC |
| Unknown | 3/6 (50) | 0/1 (0) | 50 (-61, 88) |
Source: Adapted from FDA Review
1 IGA score of 0 [cleared] or 1 [minimal] with at least 2-grade improvement from baseline
Abbreviations: CI, confidence interval; IGA, Investigator Global Assessment; n, number of subjects with a response; NC, not calculated; NS, number of subjects in subgroup
Table 9. Efficacy Results: IGA 0/1 Response1 at Week 16 by Subgroup, Efficacy Population, Trial PSO-4
| Subgroup | ICOTYDE n/Ns (%) | Placebo n/Ns (%) | Difference % (95% CI) |
|---|---|---|---|
| Overall | 118/208 (57) | 6/103 (6) | 51 (42, 59) |
| Sex | |||
| Female | 34/71 (48) | 5/40 (13) | 35 (17, 50) |
| Male | 84/137 (61) | 1/63 (2) | 60 (50, 68) |
| Age group, years | |||
| 12 to 17 | 2/3 (67) | 0/3 (0) | 67 (-28, 99) |
| 18 to 44 | 59/100 (59) | 3/50 (6) | 53 (39, 64) |
| 45 to 64 | 49/85 (58) | 3/45 (7) | 51 (36, 63) |
| ≥65 | 8/20 (40) | 0/5 (0) | 40 (-16, 64) |
| Race | |||
| Asian | 25/41 (61) | 0/20 (0) | 61 (41, 76) |
| Black or African American | 1/2 (50) | 0 | NC |
| Multiple | 1/1 (100) | 0 | NC |
| Not reported | 1/3 (33) | 0/1 (0) | 33 (-81, 91) |
| White | 90/161 (56) | 6/82 (7) | 49 (38, 58) |
| Ethnicity | |||
| Hispanic or Latino | 10/16 (63) | 0/5 (0) | 62 (2, 86) |
| Not Hispanic or Latino | 102/184 (55) | 6/96 (6) | 49 (39, 58) |
| Not reported | 6/8 (75) | 0/2 (0) | 75 (-16, 99) |
Source: Adapted from FDA Review
1 IGA score of 0 [cleared] or 1 [minimal] with at least 2-grade improvement from baseline
Abbreviations: CI, confidence interval; IGA, Investigator Global Assessment; n, number of subjects with a response; NC, not calculated; NS, number of subjects in subgroup
Table 10. Efficacy Results: PASI-90 Response1 at Week 16 by Subgroup, Efficacy Population, Trial PSO-1
| Subgroup | ICOTYDE n/Ns (%) | Placebo n/Ns (%) | Difference % (95% CI)2 |
|---|---|---|---|
| Overall | 171/311 (55) | 6/156 (4) | 51 (44, 57) |
| Sex | |||
| Female | 58/88 (65) | 4/51 (8) | 58 (44, 70) |
| Male | 113/223 (51) | 2/105 (2) | 49 (41, 56) |
| Age group, years | |||
| 18 to 44 | 83/139 (60) | 1/69 (1) | 58 (48, 67) |
| 45 to 64 | 69/140 (49) | 4/69 (6) | 44 (32, 53) |
| ≥65 | 19/32 (59) | 1/18 (6) | 54 (26, 72) |
| Race | |||
| American Indian or Alaska Native | 0/1 (0) | 0/1 (0) | NC |
| Asian | 31/69 (45) | 0/34 (0) | 45 (32, 57) |
| Black or African American | 1/4 (25) | 0/3 (0) | 25 (-49, 81) |
| Native Hawaiian or other Pacific Islander | 2/2 (100) | NA | NC |
| White | 133/231 (58) | 6/118 (5) | 52 (44, 60) |
| Not reported | 2/2 (100) | NA | NC |
| Unknown | 2/2 (100) | NA | NC |
| Ethnicity | |||
| Hispanic or Latino | 34/58 (59) | 1/25 (4) | 55 (35, 69) |
| Not Hispanic or Latino | 136/250 (54) | 5/129 (4) | 50 (43, 57) |
| Not reported | 1/2 (50) | 0/2 (0) | 50 (-61, 99) |
| Unknown | 0/1 (0) | NA | NC |
Source: Adapted from FDA Review
1 At least a 90% improvement in PASI score from baseline
Abbreviations: CI, confidence interval; n, number of subjects with a response; NA, not applicable; NC, not calculated; NS, number of subjects in subgroup; PASI, Psoriasis Area and Severity Index
Table 11. Efficacy Results: PASI-90 Response1 at Week 16 by Subgroup, Efficacy Population, Trial PSO-2
| Subgroup | ICOTYDE n/Ns (%) | Placebo n/Ns (%) | Difference % (95% CI) |
|---|---|---|---|
| Overall | 184/322 (57) | 1/82 (1) | 56 (49, 62) |
| Sex | |||
| Female | 57/104 (55) | 1/27 (4) | 51 (34, 62) |
| Male | 127/218 (58) | 0/55 (0) | 58 (51, 65) |
| Age group, years | |||
| 18 to 44 | 87/158 (50) | 0/36 (0) | 55 (44, 63) |
| 45 to 64 | 79/131 (60) | 0/36 (0) | 60 (49, 69) |
| ≥65 | 18/33 (55) | 1/10 (10) | 44 (0, 66) |
| Race | |||
| American Indian or Alaska Native | 0/1 (0) | NA | NC |
| Asian | 21/34 (62) | 0/15 (0) | 62 (38, 78) |
| Black or African American | 4/9 (44) | 0/2 (0) | 44 (-42, 84) |
| Multiple | 0/1 (0) | NA | NC |
| Native Hawaiian or other Pacific Islander | 1/2 (50) | NA | NC |
| Not reported | 0/1 (0) | NA | NC |
| White | 158/274 (58) | 1/65 (2) | 56 (48, 62) |
| Ethnicity | |||
| Hispanic or Latino | 11/42 (26) | 0/12 (0) | 26 (-5, 42) |
| Not Hispanic or Latino | 172/279 (62) | 1/70 (1) | 60 (52, 66) |
| Not reported | 1/1 (100) | NA | NC |
Source: Adapted from FDA Review
1 At least a 90% improvement in PASI score from baseline
Abbreviations: CI, confidence interval; n, number of subjects with a response; NA, not applicable; NC, not calculated; NS, number of subjects in subgroup; PASI, Psoriasis Area and Severity Index
Table 12. Efficacy Results: PASI-90 Response1 at Week 16 by Subgroup, Efficacy Population, Trial PSO-3
| Subgroup | ICOTYDE n/Ns (%) | Placebo n/Ns (%) | Difference % (95% CI)2 |
|---|---|---|---|
| Overall | 226/456 (50) | 10/228 (4) | 45 (40, 50) |
| Sex | |||
| Female | 89/165 (54) | 7/72 (10) | 44 (32, 54) |
| Male | 137/291 (47) | 3/156 (2) | 45 (39, 51) |
| Age group, years | |||
| 12 to 17 | 31/44 (70) | 3/22 (14) | 57 (32, 74) |
| 18 to 44 | 105/208 (50) | 3/92 (3) | 47 (38, 55) |
| 45 to 64 | 72/164 (44) | 4/89 (4) | 39 (30, 48) |
| ≥65 | 18/40 (45) | 0/25 (0) | 45 (28, 62) |
| Race | |||
| American Indian or Alaska Native | NA | 0/1 (0) | NC |
| Asian | 60/110 (55) | 4/57 (7) | 48 (34, 58) |
| Black or African American | 3/6 (50) | 0/2 (0) | 50 (-43, 88) |
| Native Hawaiian or other Pacific Islander | 1/2 (50) | NA | NC |
| White | 161/329 (49) | 6/165 (4) | 45 (39, 51) |
| Not reported | 0/5 (0) | 0/2 (0) | NC |
| Unknown | 1/3 (33) | 0/1 (0) | 33 (-81, 91) |
| Multiple | 0/1 (0) | NA | NC |
| Ethnicity | |||
| Hispanic or Latino | 19/61 (31) | 2/27 (7) | 24 (2, 39) |
| Not Hispanic or Latino | 203/386 (53) | 8/199 (4) | 49 (43, 54) |
| Not reported | 3/3 (100) | 0/1 (0) | NC |
| Unknown | 1/6 (17) | 0/1 (0) | 17 (-86, 64) |
Source: Adapted from FDA Review
1 At least a 90% improvement in PASI score from baseline
Abbreviations: CI, confidence interval; n, number of subjects with a response; NA, not applicable; NC, not calculated; NS, number of subjects in subgroup; PASI, Psoriasis Area and Severity Index
What are the possible side effects?
The most common side effects of ICOTYDE are headache, nausea, cough, fungal infection, and fatigue.
What are the possible side effects (results of trials used to assess safety)?
Table 13 summarizes adverse reactions that occurred in ≥1% frequency in the safety population that enrolled into the clinical trials used to evaluate the safety and efficacy of ICOTYDE.
Table 13. Adverse Reactions That Occurred in ≥1% of Subjects in the ICOTYDE Group and More Frequently Than in the Placebo Group Through Week 16, Safety Population, Pooled Trials PSO-1, PSO-2, PSO-3, and PSO-4
| Adverse Reactions | ICOTYDE N=1296 n (%) | Placebo N=568 n (%) |
|---|---|---|
| Headache | 51 (4.1) | 19 (3.3) |
| Nausea | 15 (1.2) | 3 (0.5) |
| Cough | 15 (1.2) | 1 (0.2) |
| Fungal infection1 | 14 (1.1) | 0 (0) |
| Fatigue | 15 (1.0) | 3 (0.5) |
Source: ICOTYDE Prescribing Information
1 Fungal infection includes tinea pedis (n=4), tinea versicolor (n=2), oral candidiasis (n=2), onychomycosis (n=1), skin candida (n=1), urinary tract candidiasis (n=1), vulvovaginal candidiasis (n=1), fungal skin infection (n=1), genital infection fungal (n=1), ear infection fungal (n=1), and laryngitis fungal (n=1). Two subjects experienced more than 1 event.
Abbreviations: N, number of subjects in treatment group; n, number of subjects with adverse reaction.
Adverse reactions that occurred in <1% of subjects in the ICOTYDE group and at a higher rate than in the placebo group through Week 16 in Trials PSO-1, PSO-2, PSO-3, and PSO-4 were: gastritis, abdominal discomfort, and one fatal case of gastroesophageal variceal bleeding in a subject with underlying risk factors. A relationship of this event to ICOTYDE is not established.
Were there any differences in side effects among sex, race, age, and ethnicity groups?
- Sex: Side effects from ICOTYDE were similar in females and males.
- Race: Side effects from ICOTYDE were similar in patients who were White and Asian. The number of patients of races other than White or Asian was small; therefore, differences among other races in side effects from ICOTYDE could not be determined.
- Age: Side effects from ICOTYDE were similar across age groups.
- Ethnicity: Side effects from ICOTYDE were similar in patients who were Hispanic or Latino and who were not Hispanic or Latino.
Were there any differences in side effects among sex, race, age, and ethnicity groups?
Table 14 summarizes adverse reactions by sex, race, age, and ethnicity in the safety population in the clinical trials used to evaluate the safety and efficacy of ICOTYDE.
Table 14. Overview of Adverse Events in Trials Through Week 16 by Subgroup, Safety Population, Pooled Trials PSO-1, PSO-2, PSO-3, and PSO-4
| Subgroup | ICOTYDE N=1296 n/Ns (Adjusted %) | Placebo N=568 n/Ns (Adjusted %) |
|---|---|---|
| Any adverse event | 636/1296 (49.0) | 295/568 (52.0) |
| Sex | ||
| Female | 235/428 (55.0) | 113/190 (59.6) |
| Male | 401/868 (46.2) | 182/378 (48.1) |
| Age group, years | ||
| 12 to 17 | 22/47 (45.4) | 18/25 (72.2) |
| 18 to 44 | 275/605 (46.0) | 134/247 (54.4) |
| 45 to 64 | 277/519 (53.0) | 119/238 (50.1) |
| ≥65 | 62/125 (48.3) | 24/58 (41.7) |
| Race | ||
| American Indian or Alaska Native | 1/2 (0) | 1/2 (100) |
| Asian | 133/254 (52.5) | 64/126 (50.6) |
| Black or African American | 4/21 (26.6) | 4/7 (52.2) |
| Native Hawaiian or other Pacific Islander | 4/6 (NA) | 0/0 (NA) |
| White | 485/994 (48.6) | 226/429 (52.8) |
| Multiple | 0/3 (NA) | 0/0 (NA) |
| Not reported | 4/10 (43.2) | 0/3 (0) |
| Unknown | 5/6 (100) | 0/1 (0) |
| Ethnicity | ||
| Hispanic or Latino | 85/177 (48.0) | 33/69 (47.7) |
| Not Hispanic or Latino | 542/1098 (49.2) | 261/493 (53.1) |
| Not reported | 5/13 (38.8) | 1/5 (14.9) |
| Unknown | 4/8 (66.7) | 0/1 (0) |
Source: Adapted from FDA Review
Abbreviations: n, number of subjects with any adverse event; NA, not applicable; NS, number of subjects in subgroup
GLOSSARY
CLINICAL TRIAL: A voluntary research study 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 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 those of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.