STEQEYMA was compared with Stelara® in a switch trial of adult
patients with moderate-to-severe plaque psoriasis1
STEQEYMA and Stelara patients continued on therapy for 52 weeks1
Inclusion criteria: Patients 18–80 (inclusive), with moderate-to-severe plaque-type psoriasis (defined as Psoriasis Area and Severity Index [PASI] score ≥12, involved body surface area ≥10%, and static Physician’s Global Assessment [sPGA] score ≥3) with or without PsA, diagnosed for ≥24 weeks prior to first study drug administration.1
- Primary endpoint: Mean percent improvement from baseline in Psoriasis Area Severity Index (PASI) score at week 121
- Additional endpoints: Efficacy, pharmacokinetics, safety, and immunogenicity endpoints were evaluated through week 521
- Treatment period 1 (week 0 to week 16): Patients were randomized 1:1 to receive either STEQEYMA or EU-Stelara subcutaneously; 45 mg or 90 mg for patients with baseline body weight ≤100 kg or >100 kg, respectively, at weeks 0 and 41
- Treatment period 2 (week 16 to week 40): Patients receiving EU-Stelara were re-randomized 1:1 to continue EU-Stelara or switch to STEQEYMA; patients initially receiving STEQEYMA continued receiving STEQEYMA (at weeks 16, 28, and 40)1
PsA, psoriatic arthritis.
STEQEYMA and Stelara showed similar improvement in
plaque psoriasis symptoms1
STEQEYMA and Stelara results were not significantly different at week 121
Mean PASI score improvement from baseline at week 121*
- Mean PASI score improvement from baseline at week 12 was assessed as the primary endpoint1
- For the demonstration of efficacy, the point estimate and 90% CI for the estimate of treatment difference was entirely within the predefined equivalence margin of –10% to 10%, which demonstrated therapeutic equivalence between the STEQEYMA and EU-Stelara groups in the mean percent PASI score improvement from baseline at week 12 (90% CI: [-0.23, 4.32] for the mITT set and [-0.29, 4.29] for the PPS)1
- Based partly on the findings of this study, STEQEYMA has been approved as biosimilar to Stelara across all Stelara indications including moderately to severely active ulcerative colitis, moderately to severely active Crohn's disease, moderate to severe plaque psoriasis, and active psoriatic arthritis. The FDA looks at a wide variety of tests and data to determine that a drug is biosimilar to another, including clinical trials, blood and immune-system evaluations, and chemical analyses. STEQEYMA passed those tests and is officially biosimilar to Stelara1-4
ANCOVA, analysis of covariance; FDA, Food and Drug Administration; mITT, modified intention-to-treat; PASI, Psoriasis Area and Severity Index; PPS, per-protocol set.
*Analysis used ANCOVA and multiple imputation (per FDA protocol). In the case of the per-protocol set, patients received study drug at weeks 0 and 4 and had PASI data available at baseline and week 12.1
STEQEYMA and Stelara patients showed similar plaque psoriasis
symptom change to 1 year1,3,5
STEQEYMA and Stelara group mean PASI scores were consistent—including in the switch population1,3,5
Mean PASI score1,3,5
- PASI scores and change from baseline PASI scores were assessed as secondary endpoints2
- PASI score is based on 3 factors: erythema, induration, and scaling of psoriatic lesions. Each factor is assessed from 0 to 4 (none=0, mild=1, moderate=2, severe=3, very severe=4)6
PASI, Psoriasis Area and Severity Index.
STEQEYMA and Stelara patients had similar plaque psoriaris symptom change at 52 weeks1,3
STEQEYMA and Stelara group mean change in PASI scores were similar over the duration of the study1,3
Mean PASI score change from baseline (%)1,3
- PASI score, change from baseline PASI score, and the proportions of patients with static Physician’s Global Assessment (sPGA) scores of 0 (clear) or 1 (almost clear) were assessed as secondary endpoints1
- The proportion of patients with an sPGA of clear or almost clear skin was comparable in both treatment groups at weeks 0, 2, 4, 8, 12, 16, 28, 40, and 521,3
Proportion of patients with a response (%)1,3
PASI 50
PASI 75
PASI 90
PASI 100
- PASI score, change in PASI score, and proportions of patients achieving 50/75/90/100% change from baseline PASI scores (PASI 50/75/90/100), were assessed as secondary endpoints1
PASI, Psoriasis Area and Severity Index.
STEQEYMA delivered similar drug exposure to Stelara5
STEQEYMA and Stelara serum concentrations remained comparable throughout the study5
Serum concentrations (µg/mL) during treatment periods 1 and 25
45 mg
90 mg
- Pharmacokinetic data were assessed as a secondary endpoint1
- Patients receiving the 45-mg dose of STEQEYMA demonstrated comparable serum concentrations to those taking the same dose of EU-Stelara at all measured time points, with similar consistency observed in the 90-mg dose comparison between STEQEYMA and EU-Stelara5
STEQEYMA immune profile was consistent with the Stelara profile5
STEQEYMA and Stelara ADA profiles were similar at week 28—even in the switch population5
Patients ADA+ at week 28 (%)5
- Immunogenicity was assessed as a secondary endpoint1
- Similar trends were observed across groups in treatment period 21
- No change in ADA frequency after switching from EU-Stelara to STEQEYMA1
ADA, antidrug antibody; ADA+, antidrug antibody positive.
STEQEYMA safety profile is similar to Stelara1
TEAEs: Patients with at least one adverse event related to study drug1
TESAEs: Patients with at least one serious adverse event related to study drug1
- Safety was assessed as a secondary endpoint1
- The most common adverse reactions (≥3%) reported in patients receiving ustekinumab were1:
- Psoriasis (45 mg): Nasopharyngitis (8%), upper respiratory tract infection (5%), headache (5%), and fatigue (3%)
- Psoriasis (90 mg): Nasopharyngitis (7%), upper respiratory tract infection (4%), headache (5%), and fatigue (3%)
- CD Induction: Vomiting (4%)
- CD Maintenance: Nasopharyngitis (11%), injection site erythema (5%), vulvovaginal candidiasis/mycotic infection (5%), bronchitis (5%), pruritus (4%), urinary tract infection (4%), and sinusitis (3%)
- UC Induction: Nasopharyngitis (7%)
- UC Maintenance: Nasopharyngitis (24%), headache (10%), abdominal pain (7%), influenza (6%), fever (5%), diarrhea (4%), sinusitis (4%), fatigue (4%), and nausea (3%)
- Two cases of posterior reversible encephalopathy syndrome (PRES), also known as reversible posterior leukoencephalopathy syndrome (RPLS), were reported in Stelara clinical trials. See Warnings and Precautions in the Full Prescribing Information1
STEQEYMA and Stelara demonstrated similar safety profiles1,3
TEAEs in ≥3% of patients in any treatment group5
| System organ class preferred term | Treatment period 1 | Treatment period 2 | |||
|---|---|---|---|---|---|
|
STEQEYMA (n=256) |
Stelara (n=253) |
Continued STEQEYMA (n=253) |
Continued Stelara (n=125) |
Switched to STEQEYMA (n=124) |
|
| COVID-19 | 11 (4.3%) | 12 (4.7%) | 13 (5.1%) | 11 (8.8%) | 7 (5.6%) |
| Upper respiratory tract infection | 3 (1.2%) | 8 (3.2%) | 10 (4.0%) | 4 (3.2%) | 7 (5.6%) |
| Latent tuberculosis | - | - | 7 (2.8%) | 4 (3.2%) | 4 (3.2%) |
| Nasopharyngitis | - | - | 1 (0.4%) | 1 (0.8%) | 4 (3.2%) |
| Alanine aminotransferase increased | - | - | 3 (1.2%) | 3 (2.4%) | 6 (4.8%) |
| Aspartate aminotransferase increased | - | - | 2 (0.8%) | 3 (2.4%) | 4 (3.2%) |
| Hypertriglyceridemia | - | - | 4 (1.6%) | 1 (0.8%) | 4 (3.2%) |
TEAEs in ≥3% of Patients in Any Treatment Group5
Started
Continued
Switched To
| System organ class preferred term | Treatment period 1 | |
|---|---|---|
|
STEQEYMA (n=256) |
Stelara (n=253) |
|
| COVID-19 | 11 (4.3%) | 12 (4.7%) |
| Upper respiratory tract infection | 3 (1.2%) | 8 (3.2%) |
| Latent tuberculosis | - | - |
| Nasopharyngitis | - | - |
| Alanine aminotransferase increased | - | - |
| Aspartate aminotransferase increased | - | - |
| Hypertriglyceridemia | - | - |
| System organ class preferred term | Treatment period 2 | |
|---|---|---|
|
STEQEYMA (n=253) |
Stelara (n=125) |
|
| COVID-19 | 13 (5.1%) | 11 (8.8%) |
| Upper respiratory tract infection | 10 (4.0%) | 4 (3.2%) |
| Latent tuberculosis | 7 (2.8%) | 4 (3.2%) |
| Nasopharyngitis | 1 (0.4%) | 1 (0.8%) |
| Alanine aminotransferase increased | 3 (1.2%) | 3 (2.4%) |
| Aspartate aminotransferase increased | 2 (0.8%) | 3 (2.4%) |
| Hypertriglyceridemia | 4 (1.6%) | 1 (0.8%) |
| System organ class preferred term | Treatment period 2 | |
|---|---|---|
|
STEQEYMA (n=124) |
||
| COVID-19 | 7 (5.6%) | |
| Upper respiratory tract infection | 7 (5.6%) | |
| Latent tuberculosis | 4 (3.2%) | |
| Nasopharyngitis | 4 (3.2%) | |
| Alanine aminotransferase increased | 6 (4.8%) | |
| Aspartate aminotransferase increased | 4 (3.2%) | |
| Hypertriglyceridemia | 4 (3.2%) | |
- Safety was assessed as a secondary endpoint1
- During treatment period 1, similar proportions of patients in the STEQEYMA group (37.1%) and the EU-Stelara group (29.6%) experienced TEAEs of any intensity1
- During treatment period 2, incidence of TEAEs was also similar between patients continuing STEQEYMA (15.8%), patients continuing Stelara (22.4%) and patients switching to STEQEYMA (21.0%)1
TEAE, treatment-emergent adverse event; TESAE, treatment-emergent serious adverse event.
References: 1. Papp KA, Lebwohl MG, Thaci D, et al. Efficacy and safety of candidate biosimilar CT-P43 originator ustekinumab in moderate to severe plaque psoriasis: 28-week results of a randomised, active-controlled, double blind, phase III study. BioDrugs. 2023;38(1):121-131. 2. STEQEYMA Prescribing Information. Celltrion USA, Inc; 2024. 3. Data on file. Celltrion USA, Inc. 2024. 4. Stelara Prescribing Information. Janssen Pharmaceutical Companies; 2024. 5. Papp KA, Lebwohl MG, Thaci D, et al. Efficacy and safety of candidate biosimilar CT-P43 originator ustekinumab in moderate to severe plaque psoriasis: 28-week results of a randomised, active-controlled, double blind, phase III study [supplementary data submitted for publication but not yet published]. BioDrugs. 6. Ali Z, Robert Zibert J, Dahiya P, et al. Mild-to-moderate severity of psoriasis may be assessed remotely based on photographs and self-reported extent of skin involvement. JAAD Int. 2023;11:129-136.