TREMFYA®
(guselkumab)
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TREMFYA® (guselkumab)
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Use of TREMFYA in Adult Patients with Comorbid Metabolic Syndrome
Last Updated: 01/04/2025
SUMMARY
- The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
- Post hoc analyses of VOYAGE 1 and VOYAGE 2, two phase 3, randomized, double-blind, placebo- and active comparator-controlled clinical trials among patients with moderate to severe plaque psoriasis (PsO), assessed the efficacy and safety of TREMFYA among patients with and without metabolic syndrome at baseline.1
, 2 - Through week 24, in patients with vs without metabolic syndrome, the proportions of patients in the placebo→TREMFYA, TREMFYA, and adalimumab groups who achieved a 100% improvement from baseline in Psoriasis Area and Severity Index (PASI 100) responses were 10.8% vs 20.4%, 40.1% vs 45.4%, and 13.4% vs 28.5%, respectively, and an Investigator’s Global Assessment (IGA) score of cleared or minimal (IGA 0/1) responses were 72.3% vs 77.8%, 77.5% vs 85.5%, and 48.2% vs 66.6%, respectively.1
- The proportion of TREMFYA-treated patients who achieved IGA and PASI responses among those with metabolic syndrome as compared to those without was numerically lower. At week 252, in patients with vs without metabolic syndrome, the proportions of patients who achieved IGA 0/1 responses were 76.6% vs 85.2%; a ≥90% improvement from baseline in the PASI (PASI 90) were 77.7% vs 83.4%; an IGA score of cleared (IGA 0) were 50.8% vs 56.1%; and PASI 100 responses were 48.4% vs 53.9%.2
Clinical data in Plaque psoriasis
VOYAGE 1 and VOYAGE 2
Blauvelt et al (2020)1 conducted post hoc analyses of VOYAGE 1 and VOYAGE 2, two phase 3, randomized, double-blind, placebo- and active comparator-controlled clinical trials among patients with moderate to severe plaque PsO, to evaluate the efficacy and safety of TREMFYA among patients with and without metabolic syndrome at baseline.
Study Design/Methods
- The proportions of patients who achieved ≥75% improvement from baseline in PASI (PASI 75), PASI 90, PASI 100, IGA 0/1, and IGA 0 were assessed by their metabolic syndrome status at baseline through week 24.
- Safety was determined by metabolic syndrome status at baseline through week 28.
Results
- For demographics and disease characteristics by metabolic syndrome status at baseline, see Table: Demographics and Disease Characteristics at Baseline.
| Characteristics | PBO (n=422) | TREMFYA (n=825) | ADA (n=582) | Total (N=1829) | ||||
|---|---|---|---|---|---|---|---|---|
| With MetS | Without MetS | With MetS | Without MetS | With MetS | Without MetS | With MetS | Without MetS | |
| Pooled patients randomized at week 0, n | 73 | 349 | 182 | 643 | 112 | 470 | 367 | 1462 |
| Age (years), mean±SD | 47.2±11.35 | 43.3±12.77 | 48.2±12.06 | 42.5±12.26 | 45.5±11.47 | 42.4±12.42 | 47.2±11.77 | 42.7±12.43 |
| Male, n (%) | 59 (80.8) | 233 (66.8) | 127 (69.8) | 462 (71.9) | 77 (68.8) | 342 (72.8) | 263 (71.7) | 1037 (70.9) |
| Weight (kg), mean±SD | 108.2±19.42 | 84.2±20.10 | 102.9±17.60 | 85.5±19.66 | 103.6±19.62 | 85.8±20.55 | 104.2±18.66 | 85.3±20.05 |
| BMI (kg/m2), mean±SD | 35.2±5.15 | 28.1±6.32 | 34.4±5.10 | 28.3±6.04 | 35.1±6.26 | 28.5±5.90 | 34.7±5.49 | 28.3±6.06 |
| Duration of PsO (years), mean±SD | 17.8±11.80 | 17.7±12.17 | 18.3±12.83 | 17.8±11.89 | 16.8±12.06 | 17.4±11.29 | 17.7±12.39 | 17.6±11.76 |
| Patients with PsA, n (%) | 10 (13.7) | 66 (18.9) | 45 (24.7) | 108 (16.8) | 27 (24.1) | 79 (16.8) | 82 (22.3) | 253 (17.3) |
| BSA (%), mean±SD | 22.8±13.24 | 28.0±16.75 | 27.1±15.66 | 28.8±16.98 | 31.9±20.12 | 28.0±15.67 | 27.7±17.00 | 28.4±16.51 |
| PASI score (0-72), mean±SD | 19.7±6.37 | 21.3±8.63 | 22.0±8.77 | 22.0±9.18 | 23.9±10.97 | 21.6±8.37 | 22.1±9.20 | 21.7±8.79 |
| IGA 3 (moderate), n (%) | 48 (65.8) | 274 (78.5) | 126 (69.2) | 506 (78.7) | 73 (65.2) | 363 (77.2) | 247 (67.3) | 1143 (78.2) |
| IGA 4 (severe), n (%) | 25 (34.2) | 75 (21.5) | 56 (30.8) | 136 (21.2) | 39 (34.8) | 104 (22.1) | 120 (32.7) | 315 (21.5) |
| Abbreviations: ADA, adalimumab; BMI, body mass index; BSA, body surface area; IGA, Investigator’s Global Assessment; MetS, metabolic syndrome; PASI, Psoriasis Area and Severity Index; PBO, placebo; PsA, psoriatic arthritis; PsO, psoriasis; SD, standard deviation. | ||||||||
- For the proportions of patients who achieved PASI 75, PASI 90, PASI 100, IGA 0/1, and IGA 0 responses through week 24, see Table: Proportions of Patients Achieving PASI 75, PASI 90, PASI 100, IGA 0/1, and IGA 0 Responses through Week 24.
| Week 16 | Week 24 | |||||
|---|---|---|---|---|---|---|
| PBO | TREMFYA | ADA | PBO→ TREMFYAa | TREMFYA | ADA | |
| n | ||||||
| With MetS | 73 | 182 | 112 | 65 | 182 | 112 |
| Without MetS | 349 | 643 | 470 | 333 | 643 | 470 |
| PASI 75, % | ||||||
| With MetS | 1.4 | 83.5 | 59.8 | 72.3 | 85.7 | 59.8 |
| Without MetS | 8.3 | 89.6 | 73.8 | 80.2 | 91.1 | 74.5 |
| PASI 90, % | ||||||
| With MetS | 0 | 64.3 | 34.8 | 44.6 | 73.6 | 37.5 |
| Without MetS | 3.2 | 73.3 | 51.7 | 48.0 | 78.2 | 57.7 |
| PASI 100, % | ||||||
| With MetS | 0 | 29.1 | 12.5 | 10.8 | 40.1 | 13.4 |
| Without MetS | 0.9 | 37.2 | 20.0 | 20.4 | 45.4 | 28.5 |
| IGA 0/1, % | ||||||
| With MetS | 0 | 78.0 | 56.3 | 72.3 | 77.5 | 48.2 |
| Without MetS | 9.5 | 86.3 | 69.1 | 77.8 | 85.5 | 66.6 |
| IGA 0, % | ||||||
| With MetS | 0 | 36.8 | 17.9 | 21.5 | 48.4 | 16.1 |
| Without MetS | 1.1 | 47.4 | 29.6 | 28.5 | 53.2 | 33.6 |
| Abbreviations: ADA, adalimumab; IGA, Investigator’s Global Assessment; MetS, metabolic syndrome; PASI, Psoriasis Area and Severity Index, PBO, placebo. aIncluded patients randomized to receive placebo at baseline who crossed over to TREMFYA at week 16. | ||||||
- Safety was comparable in patients with and without metabolic syndrome; see Table: Adverse Events through Week 28.
| Patients with MetS | Patients without MetS | |||||||
|---|---|---|---|---|---|---|---|---|
| PBO | PBO→ TREMFYAa | TREMFYA | ADA | PBO | PBO→ TREMFYAa | TREMFYA | ADA | |
| Pooled treated patients, n | 73 | 65 | 181 | 112 | 349 | 333 | 642 | 469 |
| Mean follow-up duration, weeks | 15.59 | 12.05 | 27.53 | 26.84 | 16.00 | 12.05 | 27.84 | 27.80 |
| ≥1 AE, n (%) | 29 (39.7) | 20 (30.8) | 108 (59.7) | 76 (67.9) | 168 (48.1) | 123 (36.9) | 392 (61.1) | 298 (63.5) |
| Discontinued due to ≥1 AE, n (%) | 0 | 1 (1.5) | 6 (3.3) | 3 (2.7) | 4 (1.1) | 1 (0.3) | 11 (1.7) | 11 (2.3) |
| ≥1 SAE, n (%) | 2 (2.7) | 1 (1.5) | 9 (5.0) | 5 (4.5) | 4 (1.1) | 7 (2.1) | 19 (3.0) | 14 (3.0) |
| ≥1 Infection, n (%) | 14 (19.2) | 10 (15.4) | 62 (34.3) | 46 (41.1) | 76 (21.8) | 73 (21.9) | 219 (34.1) | 168 (35.8) |
| Abbreviations: ADA, adalimumab; AE, adverse event; MetS, metabolic syndrome; PBO, placebo; SAE, serious adverse event. aIncluded patients randomized to receive placebo at baseline who crossed over to TREMFYA at week 16. | ||||||||
Study Design/Methods
- TREMFYA-treated patients (N=1721) included randomized patients to receive:
- TREMFYA at baseline
- Placebo at baseline and cross over to TREMFYA at week 16
- Adalimumab at baseline and cross over to TREMFYA at or after week 28 (VOYAGE 2) or at week 52 (VOYAGE 1).
- Metabolic syndrome was defined as fulfilling ≥3 of the following criteria at baseline:
- Body mass index (surrogate for waist circumference) >30 kg/m2
- Triglyceride levels ≥150 mg/dL
- High-density lipoprotein cholesterol levels <40 mg/dL in men and <50 mg/dL in women
- Blood pressure ≥130/≥85 mmHg
- Fasting glucose levels ≥110 mg/dL
- Analyses for PASI 90, PASI 100, IGA 0/1, and IGA 0 responses were performed after applying treatment failure rules on observed data. Thus, patients who discontinued the study agent due to lack of efficacy or worsening of PsO or who used a protocol-prohibited treatment for PsO were considered nonresponders.
- Mean body weight and blood pressure evaluations were performed at baseline and weeks 100, 156, 204, and 264.
- Safety was evaluated through week 264.
Results
- At baseline, 334/1721 (19.4%) patients had metabolic syndrome. For baseline demographics and clinical characteristics, see Table: Baseline Demographics, Disease Characteristics, and Medical History/Current Diagnoses of Interest Among Pooled Patients Treated with TREMFYA.
| Characteristics | Patients with MetS | Patients without MetS |
|---|---|---|
| Pooled patients randomized at week 0 and treated with TREMFYA, n | 334 | 1387 |
| Age (years), mean±SD | 47.2±11.8 | 42.7±12.4 |
| Sex (male), n (%) | 240 (71.9) | 982 (70.8) |
| Weight (kg), mean±SD | 104.0±18.7 | 85.1±20.0 |
| BMI (kg/m2), mean±SD | 34.6±5.5 | 28.2±6.0a |
| Duration of PsO (years), mean±SD | 17.8±12.4 | 17.8±11.8 |
| Patients with PsA, n (%) | 77 (23.1) | 242 (17.4) |
| BSA (%), mean±SD | 27.0±16.1 | 28.3±16.5 |
| PASI (0-72), mean±SD | 21.7±8.8 | 21.7±8.8 |
| IGA 3 (moderate), n (%) | 226 (67.7) | 1090 (78.6) |
| IGA 4 (severe), n (%) | 108 (32.3) | 295 (21.3) |
| Medical history/current diagnoses of interest, n (%) | ||
| Diabetes mellitus | 76 (22.8) | 75 (5.4) |
| Hypertension | 151 (45.2) | 290 (20.9) |
| Hyperlipidemia | 89 (26.6) | 154 (11.1) |
| Abbreviations: BMI, body mass index; BSA, body surface area; IGA, Investigator’s Global Assessment; MetS, metabolic syndrome; PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis; PsO, psoriasis; SD, standard deviation. an=1386. | ||
- IGA and PASI responses from weeks 100 through 252 were observed among patients with and without metabolic syndrome treated with TREMFYA and are summarized in Table: Proportions of Patients Achieving PASI 90, PASI 100, IGA 0/1 and IGA 0 from Week 100 through Week 252.
| Characteristics | With MetS | Without MetS | ||||||
|---|---|---|---|---|---|---|---|---|
| Week 100 | Week 156 | Week 204 | Week 252 | Week 100 | Week 156 | Week 204 | Week 252 | |
| n | 301 | 283 | 271 | 256 | 1289 | 1232 | 1185 | 1118 |
| PASI 90, % | 77.4 | 74.9 | 75.6 | 77.7 | 81.4 | 81.2 | 81.4 | 83.4 |
| PASI 100, % | 43.5 | 43.5 | 47.2 | 48.4 | 51.7 | 51.4 | 53.3 | 53.9 |
| n | 301 | 281 | 271 | 256 | 1287 | 1230 | 1183 | 1117 |
| IGA 0/1, % | 78.7 | 76.9 | 76.0 | 76.6 | 84.7 | 84.8 | 82.9 | 85.2 |
| IGA 0, % | 47.2 | 47.0 | 47.6 | 50.8 | 55.9 | 54.2 | 55.3 | 56.1 |
| Abbreviations: IGA 0/1, Investigator’s Global Assessment score of cleared or minimal; IGA 0, Investigator’s Global Assessment score of cleared; MetS, metabolic syndrome; PASI 90, ≥90% improvement in the Psoriasis Area and Severity Index; PASI 100, 100% improvement in the Psoriasis Area and Severity Index. | ||||||||
Through week 264, mean weight and blood pressure among patients with and without metabolic syndrome treated with TREMFYA remained stable at each assessment timepoint. - Safety was comparable in patients with and without metabolic syndrome through week 264; see Table: Adverse Events through Week 264.
| Patients with MetS | Patients without MetS | |
|---|---|---|
| Pooled treated patients, n | 334 | 1387 |
| Mean follow-up duration, weeks | 213.2 | 218.3 |
| ≥1 AE, n (%) | 290 (86.8) | 1202 (86.7) |
| Discontinued due to ≥1 AE, n (%) | 30 (9.0) | 74 (5.3) |
| ≥1 SAE, n (%) | 60 (18.0) | 219 (15.8) |
| ≥1 Infection, n (%) | 226 (67.7) | 957 (69.0) |
| Candida infectionsa, n (%) | 7 (2.1) | 21 (1.5) |
| Non-pathogen-specific fungal infections suspicious for Candidab | 3 (0.9) | 3 (0.2) |
| Serious infections, n (%) | 13 (3.9) | 37 (2.7) |
| Active tuberculosis, n (%) | 0 | 0 |
| NMSC, n (%) | 8 (2.4) | 16 (1.2) |
| Malignancies other than NMSC, n (%) | 12 (3.6) | 20 (1.4) |
| MACE, n (%) | 5 (1.5) | 16 (1.2) |
| Abbreviations: AE, adverse event; MACE, major adverse cardiovascular event; MedDRA, Medical Dictionary for Regulatory Activities; MetS, metabolic syndrome; NMSC, nonmelanoma skin cancer; SAE, serious adverse event. aSearch criterion: MedDRA high-level term, Candida infections. bAs determined by diagnosis and location; search criteria included MedDRA preferred terms: fungal balanitis, genital infection fungal, vulvovaginal mycotic infection, oral fungal infection, tongue fungal infection, oropharyngitis fungal, fungal esophagitis; only preferred terms matching these search criteria were included. | ||
Literature Search
A literature search of MEDLINE®
References
| 1 | Blauvelt A, Thaçi D, Merola JF, et al. Response to guselkumab treatment among psoriasis patients with and without metabolic syndrome: post hoc analyses from VOYAGE 1 and VOYAGE 2. Poster presented at: European Academy of Dermatology and Venereology (EADV) Congress; October 29-31, 2020; Virtual. |
| 2 |