Drug Trials Snapshots: SOTYKTU
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 SOTYKTU Prescribing Information. 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).
SOTYKTU (deucravacitinib)
(soh-tik-too)
Bristol Myers Squibb Co.
Approval date: September 9, 2022
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
SOTYKTU is a tyrosine kinase 2 (TYK2) inhibitor that is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
How is this drug used?
SOTYKTU is a tablet for oral use that is taken once a day with or without food.
Who participated in the clinical trials?
The FDA approved SOTYKTU based on evidence from two clinical trials of 1,684 patients with moderate-to-severe plaque psoriasis. The trials were conducted at 216 sites in 20 countries: Australia, Canada, China, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Hungary, Israel, Japan, Korea, New Zealand, Poland, Puerto Rico, Russia, Sweden, Taiwan, and the United States.
What are the benefits of this drug?
More patients achieved clear or almost clear skin after treatment with SOTYKTU in comparison to those who were treated with placebo.
What are the benefits of this drug (results of trials used to assess efficacy)?
The tables below summarize efficacy results for the evaluated patients in Trials PSO-1 and PSO-2. The co-primary efficacy endpoints were the following comparing SOTYKU-treated patients to placebo-treated patients:
- sPGA 0/1: The proportion of patients who achieved static Physician’s Global Assessment (sPGA) score of 0 (clear) or 1 (minimal) at Week 16
- PASI 75: The proportion of patients who achieved at least 75% reduction from baseline in Psoriasis Area and Severity Index (PASI) score at Week 16
Table 1. Efficacy Results in Adults With Moderate to Severe Plaque Psoriasis (NRI) in POETYK PSO-1
| Endpoint | SOTYKTU N=330 n (%) |
Placebo N=166 n (%) |
Apremilast N=168 n (%) |
Difference, % (95% CI)a | |
|---|---|---|---|---|---|
| Difference From Placebo | Difference From Apremilast | ||||
| sPGA response of 0/1 (clear or almost clear) | |||||
| Week 16 b | 178 (54) | 12 (7) | 54 (32) | 47 (40, 53) | 22 (13, 30) |
| Week 24 | 194 (59) | - | 52 (31) | - | 27 (19, 36) |
| sPGA response of 0 | |||||
| Week 16 | 58 (18) | 1 (1) | 8 (5) | 17 (13, 21) | 13 (8, 18) |
| PASI 75 response | |||||
| Week 16 b | 193 (58) | 21 (13) | 59 (35) | 46 (39, 53) | 23 (14, 32) |
| Week 24 | 228(69) | - | 64 (38) | - | 31 (22, 40) |
| PASI 90 response | |||||
| Week 16 | 118 (36) | 7 (4) | 33 (20) | 32 (26, 38) | 16 (8, 24) |
| Week 24 | 140 (42) | - | 37 (22) | - | 20 (12, 28) |
| PASI 100 response | |||||
| Week 16 | 47 (14) | 1 (1) | - | 14 (10, 18) | - |
| ss-PGA response of 0/1 (scalp) c | N=209 | N=121 | N=110 | ||
| Week 16 | 147 (70) | 21 (17) | 43 (39) | 53 (44, 62) | 30 (19, 41) |
Source: Adapted from FDA Review
a Adjusted difference in proportions is the weighted average of the treatment differences across region, body weight and prior biologic use with the Cochran-Mantel-Haenszel weights.
b Co-primary endpoints comparing SOTYKTU to placebo
c Includes only patients with baseline ss-PGA score of ≥
Abbreviations: CI, Confidence interval; NRI, Non-Responder Imputation; PASI, Psoriasis Area and Severity Index; sPGA, Static Physician Global Assessment; ss-PGA, Scalp Specific Physician’s Global Assessment
Table 2. Efficacy Results in Adults With Moderate to Severe Plaque Psoriasis (NRI) in POETYK PSO-2
| Endpoint | SOTYKTU N=511 n (%) |
Placebo N=255 n (%) |
Apremilast N=254 n (%) |
Difference, % (95% CI)a | |
|---|---|---|---|---|---|
| Difference From Placebo | Difference From Apremilast | ||||
| sPGA response of 0/1 (clear or almost clear) | |||||
| Week 16 b | 253 (50) | 22 (9) | 86 (34) | 42 (36, 47) | 16 (9, 23) |
| Week 24 | 251 (49) | - | 75 (30) | - | 20 (13, 27) |
| sPGA response of 0 | |||||
| Week 16 | 80 (16) | 3 (1) | 16 (6) | 14 (11, 18) | 9 (5, 14) |
| PASI 75 response | |||||
| Week 16 b | 271 (53) | 24 (9) | 101 (40) | 44 (38, 49) | 14 (6, 21) |
| Week 24 | 296 (58) | - | 96 (38) | - | 20 (13, 27) |
| PASI 90 response | |||||
| Week 16 | 138 (27) | 7 (3) | 46 (18) | 24 (20, 29) | 9 (3, 15) |
| Week 24 | 164 (32) | - | 50 (20) | - | 13 (6, 19) |
| PASI 100 response | |||||
| Week 16 | 52 (10%) | 3 (1) | - | 9 (6, 12) | - |
| ss-PGA response of 0/1 (scalp) c | N=305 | N=173 | N=166 | ||
| Week 16 | 182 (60) | 30 (17) | 61 (37) | 42 (34, 50) | 23 (14, 33) |
Source: Adapted from FDA Review
a Adjusted difference in proportions is the weighted average of the treatment differences across region, body weight and prior biologic use with the Cochran-Mantel-Haenszel weights.
b Co-primary endpoints comparing SOTYKTU to placebo
c Includes only patients with baseline ss-PGA score of ≥3
Abbreviations: CI, Confidence interval; NRI, Non-Responder Imputation; PASI, Psoriasis Area and Severity Index; sPGA, Static Physician Global Assessment; ss-PGA, Scalp Specific Physician’s Global Assessment
Were there any differences in how well the drug worked in clinical trials among sex, race and age?
- Sex: SOTYKTU worked similarly in males and females.
- Race: The number of patients of races other than White and Asian was limited; therefore , differences in response among other races could not be determined.
- Age: The observed treatment effects were similar for patients 18 to 64 years old and for patients >65 years old.
Were there any differences in how well the drug worked in clinical trials among sex, race, and age groups?
The tables below summarize efficacy results at Week 16 by age, sex, and race.
Table 3. sPGA 0/1 at Week 16 by Age, Sex, Race – Trial PSO-1 (FAS; NRI1)
| Subgroups (n[SOTYKTU ], n[PBO]) | SOTYKTU N=330 |
PBO N=166 |
Difference (95% CI) |
|---|---|---|---|
| Age (years) | |||
| 18 to 64 (304, 141) | 54% | 7% | 47% (40%, 54%) |
| ≥65 (26, 25) | 58% | 8% | 50% (28%, 71%) |
| Sex | |||
| Male (230, 113) | 50% | 5% | 45% (37%, 52%) |
| Female (100, 53) | 63% | 11% | 52% (39%, 64%) |
| Race | |||
| White (265, 128) | 51% | 8% | 43% (36%, 51%) |
| Black or African American (2, 3) | 50% | 0% | - |
| Asian (59, 34) | 68% | 6% | 62% (48%, 76%) |
| Overall | 54% | 7% | 40%, 53% |
Source: Adapted from FDA Review
1 Full Analysis Set (FAS), defined as all randomized patients, with Site 0092 (PSO-1) removed; missing data are imputed using the non-responder imputation (NRI).
There were 5 patients of Other race
Abbreviations: CI, Confidence Interval; DEUC, ; PBO, placebo; sPGA, Static Physician Global Assessment
Table 4. PASI-75 Response at Week 16 by Age, Sex, Race – Trial PSO-1 (FAS; NRI1)
| Subgroups (n[ SOTYKTU], n[PBO]) | SOTYKTU N=330 |
PBO N=166 |
Difference (95% CI) |
|---|---|---|---|
| Age (years) | |||
| 18 to 64 (304, 141) | 58% | 14% | 44% (36%, 52%) |
| ≥65 (26, 25) | 62% | 4% | 58% (37%, 78%) |
| Sex | |||
| Male (230, 113) | 57% | 10% | 47% (38%, 55%) |
| Female (100, 53) | 63% | 19% | 44% (30%, 58%) |
| Race | |||
| White (265, 128) | 55% | 13% | 42% (34%, 51%) |
| Black or African American (2, 3) | 100% | 0% | - |
| Asian (59, 34) | 71% | 12% | 59% (44%, 75%) |
| Overall | 58% | 13% | 46% (39%, 53%) |
Source: Adapted from FDA Review
1 Full Analysis Set (FAS), defined as all randomized patients, with Site 0092 (PSO-1) removed; missing data are imputed using the non-responder imputation (NRI).
A There were 5 patients of Other race
Abbreviations: CI, Confidence Interval; DEUC, ; PASI, Psoriasis Area and Severity Index; PBO, placebo
Table 5. sPGA 0/1 at Week 16 by Age, Sex, Race, Weight - Trial PSO-2 (FAS; NRI1)
| Subgroups (n[ SOTYKTU], n[PBO]) | SOTYKTU N=511 |
PBO N=255 |
Difference (95% CI) |
|---|---|---|---|
| Age (years) | |||
| 18 to 64 (457, 229) | 49% | 9% | 41% (35%, 46%) |
| ≥65 (54, 26) | 52% | 8% | 44% (27%, 61%) |
| Sex | |||
| Male (336, 181) | 47% | 8% | 39% (32%, 46%) |
| Female (172, 74) | 54% | 9% | 44% (34%, 54%) |
| Race | |||
| White (474, 232) | 50% | 9% | 42% (36%, 47%) |
| Black or African American (8, 9) | 25% | 11% | 14% (-22%, 50%) |
| Asian (24, 8) | 46% | 13% | 33% (3%, 64%) |
| Overall | 50% | 9% | 41% (35%, 46%) |
Source: Adapted from FDA Review 1 Full Analysis Set (FAS), defined as all randomized patients; missing data are imputed using the non-responder imputation (NRI).
There were 5 patients of Other race
Abbreviations: CI, Confidence Interval; DEUC, ; PBO, placebo; sPGA, Static Physician Global Assessment
Table 6. PASI-75 Response at Week 16 by Age, Sex, Race - Trial PSO-2 (FAS; NRI1)
| Subgroups (n[ SOTYKTU], n[PBO]) | SOTYKTU N=511 |
PBO N=255 |
Difference (95% CI) |
|---|---|---|---|
| Age (years) | |||
| 18 to 64 (457, 229) | 53% | 9% | 44% (38%, 50%) |
| ≥65 (54, 26) | 54% | 15% | 38% (19%, 58%) |
| Sex | |||
| Male (336, 181) | 49% | 9% | 40% (33%, 46%) |
| Female (172, 74) | 62% | 11% | 51% (41%, 61%) |
| Race | |||
| White (474, 232) | 53% | 10% | 43% (38%, 49%) |
| Black or African American (8, 9) | 25% | 11% | 14% (-22%, 50%) |
| Asian (24, 8) | 54% | 0% | 54% (34%, 74%) |
| Overall | 53% | 9% | 44% (38%, 49%) |
Source: Adapted from FDA Review 1 Full Analysis Set (FAS), defined as all randomized patients; missing data are imputed using the non-responder imputation (NRI).
There were 5 patients of Other race
Abbreviations: CI, Confidence Interval; DEUC, ; PASI, Psoriasis Area and Severity Index; PBO, placebo\
What are the possible side effects?
The most common side effects of SOTYKTU include the common cold, sore throat, and sinus infection (upper respiratory infections), cold sores (herpes simplex), sores on the inner lips, gums, tongue, or roof of the mouth (canker sores), inflamed hair pores (folliculitis), and acne.
SOTYKTU may cause serious side effects including serious allergic reactions, infections, cancer, and muscle problems (rhabdomyolysis), increased triglycerides (a type of fat found in blood) and increased liver enzymes.
What are the possible side effects (results of trials used to assess safety)?
Table 7 below summarizes the adverse reactions that occurred in at least 1% of patients in the SOTYKTU group and at a higher rate than the placebo group during the 16-week controlled period. Presented is the safety population that includes all patients who received treatment at least once according to the approved dose regimen.
Table 7. Adverse Reactions That Occurred in ≥1% of Patients With Plaque Psoriasis in the SOTYKTU Group and More Frequently Than in the Placebo Group in Trials PSO-1 and PSO-2 Through Week 16
| Adverse Reaction | SOTYKTU 6 mg Once Daily N=840 n (%) |
Placebo N=419 n (%) |
|---|---|---|
| Upper respiratory infectionsa | 161 (19.2) | 62 (14.8) |
| Blood creatine phosphokinase increased | 23 (2.7) | 5 (1.2) |
| Herpes simplexb | 17 (2.0) | 1 (0.2) |
| Mouth ulcersc | 16 (1.9) | 0 (0.0) |
| Folliculitis | 14 (1.7) | 0 (0.0) |
| Acned | 12 (1.4) | 1 (0.2) |
Source: Adapted from FDA Review a Includes upper respiratory tract infection (viral, bacterial, and unspecified), nasopharyngitis, pharyngitis (including viral, streptococcal, and unspecified), sinusitis (includes acute, viral, bacterial), rhinitis, rhinotracheitis, tracheitis, laryngitis, and tonsillitis (including bacterial, streptococcal)
b Includes oral herpes, genital herpes, herpes simplex, and herpes virus infection
c Includes mouth ulceration, aphthous ulcer, tongue ulceration, and stomatitis
d Includes acne, acne cystic, and dermatitis acneiform
Adverse reactions that occurred in <1% of patients in the SOTYKTU group were herpes zoster.
Were there any differences in side effects among sex, race and age?
- Sex: The occurrence of side effects was similar in males and females.
- Race: The number of patients of races other than White was small; therefore, differences in the occurrence of side effects among races could not be determined.
- Age: Although the number of patients above 65 years of age was limited, for those who did not switch treatment throughout the trials, there was a higher rate of overall serious adverse reactions, including serious infections, and discontinuations due to adverse reactions compared with younger adults.
Were there any differences in side effects of the clinical trials among sex, race, and age groups?
Table 8. Adverse Events by Sex in Trials PSO-1 and PSO-2 Through Week 16
| Event | SOTYKTU N=840 |
PLACEBO N=419 |
APREMILAST N=422 |
|||
|---|---|---|---|---|---|---|
| Female N=274 |
Male N=566 |
Female N=127 |
Male N=292 |
Female N=155 |
Male N=267 |
|
| Any TEAE, n (%) | 171 (62.4) | 297 (52.4) | 66 (52.0) | 142 (48.6) | 96 (61.9) | 147 (55.0) |
| SAE, n (%) | 4 (2.3) | 10 (3.4) | 4 (3.1) | 8 (2.7) | 2 (1.3) | 3 (1.1) |
Source: Adapted from FDA Review
Abbreviations: SAE, Serious Adverse Event; TEAE, Treatment Emergent Adverse Event
Table 9. Adverse Events by Race in Trials PSO-1 and PSO-2 Through Week 16
| Event |
SOTYKTU |
PLACEBO |
APREMILAST |
|||
|---|---|---|---|---|---|---|
| White N=738 |
All Others N=102 |
White N=359 |
All Others N=60 |
White N=368 |
All Others N=54 | |
| Any TEAE, n (%) | 404 (54.7) | 64 (62.7) | 169 (47.1) | 39 (65.0) | 211 (57.4) | 32 (59.3) |
| SAE, n (%) | 10 (1.4) | 4 (3.9) | 10 (2.8) | 2 (3.3) | 4 (1.1) | 1 (1.9) |
Source: Adapted from FDA Review
Abbreviations: SAE, Serious Adverse Event; TEAE, Treatment Emergent Adverse Event
Table 10. Adverse Events by Age in Trials PSO-1 and PSO-2 Through Week 16
| Event | SOTYKTU N=840 |
PLACEBO N=419 |
APREMILAST N=422 |
|||
|---|---|---|---|---|---|---|
| <65 N=760 |
≥65 N=80 |
<65 N=368 |
≥65 N=51 |
<65 N=384 |
≥65 N=38 |
|
| Any TEAE, n (%) | 429 (56.4) | 39 (48.8) | 180 (48.9) | 28 (54.9) | 222 (57.8) | 21 (55.3) |
| SAE, n (%) | 13 (1.7) | 1 (1.3) | 9 (2.4) | 3 (5.9) | 4 (1.0) | 1 (2.6) |
Source: Adapted from FDA Review
Abbreviations: SAE, Serious Adverse Event; TEAE, Treatment Emergent Adverse Event
DEMOGRAPHICS SNAPSHOT
Figure 1 summarizes how many male and female patients were enrolled in the combined clinical trials used to evaluate the efficacy of SOTYKTU.
Figure 1. Baseline Demographics by Sex
Source: Adapted from FDA Review
Figure 2 summarizes the percentage of patients by race enrolled in the combined clinical trials used to evaluate the efficacy of SOTYKTU.
Figure 2. Baseline Demographics by Race
Source: Adapted from FDA Review
* Includes American Indian or Alaska Native, Native Hawaiian or Other Pacific Islander and Other.
Figure 3 summarizes the percentage of patients by age enrolled in the combined clinical trials used to evaluate the efficacy of SOTYKTU.
Figure 3. Baseline Demographics by Age
Source: Adapted from FDA Review
Who participated in the trials?
Table 11 below summarizes demographics for the randomized patients in the clinical trials with Site 0092 (PSO-1) removed (FAS population).
Table 11. Demographics and Baseline Disease Characteristics – Trials PSO-1 and PSO-2 (FAS1)
| Parameter | PSO-1 | PSO-2 | ||||
|---|---|---|---|---|---|---|
| SOTYKTU N=330 |
Placebo N=166 |
Apremilast N=168 |
SOTYKTU N=511 |
Placebo N=255 |
Apremilast N=254 |
|
| Age (years) | ||||||
| Mean (SD) | 45.8 (13.7) | 47.9 (14.0) | 44.7 (12.1) | 46.9 (13.4) | 47.3 (13.6) | 46.4 (13.3) |
| Median | 45 | 48 | 43 | 46 | 47 | 46 |
| Range | 18 to 80 | 19 to 81 | 20 to 77 | 18 to 84 | 18 to 83 | 18 to 79 |
| Age group, n (%) | ||||||
| <65 years | 304 (92%) | 141 (85%) | 158 (94%) | 457 (89%) | 229 (90%) | 226 (89%) |
| ≥65 years | 26 (8%) | 25 (15%) | 10 (6%) | 54 (11%) | 26 (10%) | 28 (11%) |
| Sex, n (%) | ||||||
| Female | 102 (30%) | 53 (32%) | 58 (35%) | 175 (34%) | 74 (29%) | 97 (38%) |
| Male | 230 (70%) | 113 (68%) | 110 (65%) | 336 (66%) | 181 (71%) | 157 (62%) |
| Race, n (%) | ||||||
| White | 265 (80%) | 128 (77%) | 139 (83%) | 474 (93%) | 232 (91%) | 229 (90%) |
| Black or African American | 2 (1%) | 3 (2%) | 1 (1%) | 8 (2%) | 9 (4%) | 9 (4%) |
| American Indian or Alaska Native | 0 (0%) | 0 (0%) | 0 (0%) | 2 (<1%) | 2 (1%) | 3 (1%) |
| Asian | 59 (18%) | 34 (20%) | 28 (17%) | 24 (5%) | 8 (3%) | 12 (5%) |
| Other | 4 (1%) | 1 (1%) | 0 (0%) | 3 (1%) | 4 (2%) | 1 (<1%) |
Source: Adapted from FDA Review
1 Full Analysis Set (FAS), defined as all randomized patients, with Site 0092 (PSO-1) removed
How were the trials designed?
The benefit and side effects of SOTYKTU were evaluated in two clinical trials (PSO-1 and PSO-2) of adult patients with moderate to severe plaque psoriasis.
Both trials were 52-week, multicenter, randomized, double-blind, placebo- and active comparator-controlled trials with apremilast as the comparator. In both trials, patients received SOTYKTU, placebo, or apremilast for 24 weeks, at which point the trial designs differed across the two trials. Trial PSO-2 had a randomized-withdrawal period from Week 24 to Week52.
The benefit of SOTYKTU to placebo was assessed after 16 weeks of treatment using the static Physician’s Global Assessment (sPGA) score that measures the severity of disease on a scale from 0 to 4 for all three trials and the Psoriasis Area and Severity Index (PASI).
How were the trials designed?
The efficacy of SOTYKTU was evaluated in two 52-week, multicenter, randomized, double-blind, placebo- and apremilast-controlled trials. All patients had moderate to severe psoriasis defined as a score of ≥3 using a static Physician’s Global Assessment (sPGA) severity scale of 0 to 4, a Psoriasis Area and Severity Index (PASI) score ≥12 on a scale of 0 to 72, and a minimum body surface area involvement of ≥10%.
In both trials, patients received SOTYKTU 6 mg once daily, placebo once daily, or apremilast 30 mg twice daily for 16 weeks. In Trial PSO-1, patients originally receiving SOTYKTU continued SOTYKTU to Week 52. Trial PSO-2 included a randomized-withdrawal period from Week 24 to Week 52.
The co-primary efficacy outcome measures for both trials were: 1) the proportion of patients at Week 16 who achieved success, defined as an sPGA grade of Clear (score of 0) or Almost Clear (score of 1) with a 2-grade or greater improvement from baseline; and 2) the proportion of patients who achieved at least 75% reduction from baseline in PASI score at Week 16, comparing SOTYKTU-treated patients to placebo-treated patients.
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.