TREMFYA®
(guselkumab)
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TREMFYA® (guselkumab)
Medical Information
TREMFYA – Overview of SPECTREM Clinical Trial
Last Updated: 10/30/2024
SPECTREM (NCT06039189) is an ongoing, multicenter, double-blind, randomized phase 3b clinical trial evaluating the safety and efficacy of TREMFYA compared to placebo in patients with low body surface area (BSA), moderate plaque psoriasis (PsO) with ≥1 special site involvement.1 - At week 16, the primary endpoint of Investigator’s Global Assessment (IGA) 0/1 was achieved by significantly more patients receiving TREMFYA (74%) compared to the placebo group (12%; P<0.001).2
- Safety results through week 16 were generally consistent with the known safety profile of TREMFYA. No new safety signals were identified.2
- At week 16, the primary endpoint of Investigator’s Global Assessment (IGA) 0/1 was achieved by significantly more patients receiving TREMFYA (74%) compared to the placebo group (12%; P<0.001).2
CLINICAL Data
Gold et al (2024)2, Gottlieb et al (2024)3
Study Design/Methods
- Key inclusion criteria are as follows:1,
2 - Patients (≥18 years of age) with a diagnosis of plaque PsO (with or without psoriatic arthritis [PsA]) for at least 6 months prior to administration of study intervention
- IGA=3
- BSA=2-15% with ≥1 plaque outside of special site(s)
- Involvement of ≥1 special site with at least moderate severity (scalp with scalp-specific IGA [ss-IGA] ≥3, face with facial psoriasis IGA [f-IGA] ≥3, intertriginous with intertriginous psoriasis IGA ≥3, or genital with static physician global assessment of genitalia [sPGA-G] ≥3)
- Inadequately controlled with or intolerant of at least 1 prior topical therapy for treatment of PsO
- Key exclusion criteria are as follows:1
- Non-plaque form of PsO (eg, erythrodermic, guttate, or pustular)
- Patients with palmoplantar involvement with confounding diagnoses
- Biologic-experienced for the treatment of PsO, PsA, or any other indications that could impact the assessment of PsO
- Primary and secondary outcome measures are described in Table: SPECTREM Clinical Trial Outcome Measures.1
| Primary Outcome Measure | Time Frame |
|---|---|
| Percentage of patients who achieved an IGA score of cleared (0) or minimal (1) | Week 16 |
| Secondary Outcome Measures | |
| Percentage of patients who achieved IGA score of cleared (0) | Week 16 |
| Percentage of patients who achieved PASI 90 response | Week 16 |
| Change from baseline in total PASI score | Week 16 |
| Change from baseline in BSA affected with PsO | Week 16 |
| Percentage of patients who achieved PASI 100 response | Week 16 |
| Percentage of patients who achieved ss-IGA score of absence of disease (0) or very mild disease (1) among patients with an ss-IGA score ≥3 at baseline | Week 16 |
| Percentage of patients who achieved sPGA-G score of clear (0) or minimal (1) among patients with a sPGA-G score ≥3 at baseline | Week 16 |
| Percentage of patients who achieved i-IGA score of clear (0) or minimal (1) among patients with an i-IGA score ≥3 at baseline | Week 16 |
| Percentage of patients who achieved f-IGA score of clear (0) or minimal (1) among patients with an f-IGA score ≥3 at baseline | Week 16 |
| Change from baseline in PSSD total symptom score | Week 16 |
| Percentage of patients with ≥4-point reduction from baseline in PSSD itch score among patients with PSSD itch score ≥4 at baseline | Week 16 |
| Percentage of patients with PSSD individual symptom scale score of 0 among patients with baseline PSSD symptom score >0 | Week 16 |
| Number of patients with AEs | Up to Week 56 |
| Number of patients with SAEs | Up to Week 56 |
| Note: Additional detail regarding study outcome definitions can be found on clinicaltrials.gov. Abbreviations: AE, adverse event; BSA, body surface area; f-IGA, facial investigator’s global assessment; IGA, investigator’s global assessment; i-IGA, intertriginous investigator’s global assessment; PASI, psoriasis area and severity index; PSSD, psoriasis symptoms and signs diary; SAE, serious adverse event; sPGA-G, static physician’s global assessment of genitalia; ss-IGA, scalp-specific investigator’s global assessment. | |
Patient Characteristics
- A total of 338 patients were randomized in a 2:1 ratio to receive TREMFYA 100 mg (n=225) or placebo (n=113) subcutaneously at weeks 0, 4, and then every 8 weeks with placebo crossover to TREMFYA at week 16.2
- Baseline characteristics are described in Table: Baseline Demographics and Clinical Characteristics.2-
4
| TREMFYA (n=225) | Placebo (n=113) | Total (N=338) | |
|---|---|---|---|
| Demographics | |||
| Age, years, mean (SD) | 47.0 (14.7) | 44.5 (14.9) | 46.2 (14.8) |
| Male, n (%) | 116 (51.6) | 57 (50.4) | 173 (51.2) |
| BMI, kg/m2, mean (SD) | 30.9 (7.5) | 31.0 (7.5) | 30.9 (7.5) |
| White, n (%) | 166 (73.8) | 83 (73.5) | 249 (73.7) |
| Characteristics | |||
| PsO disease duration, years, mean (SD) | 18.4 (14.9) | 14.0 (11.9) | 16.9 (14.1) |
| PASI (0-72), mean (SD) | 9.1 (3.8) | 9.0 (3.9) | 9.0 (3.8) |
| IGA, moderate (3) | 224 (99.6%)a | 113 (100%) | 337 (99.7%) |
| BSA, %, mean (SD) | 7.6 (3.7) | 7.5 (3.7) | 7.6 (3.7) |
| Previous Treatments, n (%) | |||
| Topical agentsb | 225 (100) | 113 (100) | 338 (100) |
| Phototherapyc,d | 46 (20.5) | 16 (14.3) | 62 (18.5) |
| Conventional systemicsc,e | 31 (13.8) | 15 (13.4) | 46 (13.7) |
| Advanced oralsc,f | 11 (4.9) | 4 (3.6) | 15 (4.5) |
| Patients with ≥1 special sites, n (%) | |||
| Scalp | 184 (81.8) | 97 (85.8) | 281 (83.1) |
| Face | 136 (60.4) | 71 (62.8) | 207 (61.2) |
| Intertriginous | 137 (60.9) | 66 (58.4) | 203 (60.1) |
| Genital | 99 (44.0) | 49 (43.4) | 148 (43.8) |
| Patient Reported Outcomes, mean (SD) | |||
| PSSD symptom score (0-100)g | 53.3 (23.7) | 54.9 (22.0) | 53.8 (23.2) |
| PSSD itch score (0-10)g | 6.7 (2.2) | 6.8 (2.0) | 6.8 (2.2) |
| Abbreviations: BMI, body mass index; BSA, body surface area; IGA, investigator’s global assessment; PASI, psoriasis area and severity index; PBO, placebo; PsO, plaque psoriasis; PSSD, psoriasis symptoms and signs diary; PUVA, Psoralen plus ultraviolet A; SD, standard deviation; UVB, ultraviolet B. aOne TREMFYA-randomized patient deviated from the inclusion criteria with a baseline IGA score of 4 bTopical, anthralin, keratolytics, tarc | |||
Efficacy
At week 16, the primary endpoint of IGA 0/1 was achieved by significantly more patients receiving TREMFYA (74% [167/225]) compared to the placebo group (12% [14/113]; P<0.001).2 - Major secondary endpoints are described in Table: Major Secondary Endpoints at Week 16.
| TREMFYA | Placebo | |
|---|---|---|
| Patients who achieved PASI 90, % (n/N) | 53 (119/225); P<0.001a | 6 (7/113) |
| Patients who achieved IGA 0, % (n/N) | 40 (91/225); P<0.001a | 4 (4/113) |
| Patients who achieved PASI 100, % (n/N) | 32 (73/225); P<0.001a | 3 (3/113) |
| Improvement from baseline PASI, LS mean (n) | 83 (n=220); P<0.001b | 14 (n=113) |
| Improvement from baseline BSA, LS mean (n) | 81 (n=220); P<0.001b | 6 (n=113) |
| Patients with ss-IGA ≥3 at baseline who achieved ss-IGA 0/1, % (n/N) | 75 (114/152); P<0.001c | 14 (11/76) |
| Patients with f-IGA ≥3 at baseline who achieved f-IGA 0/1, % (n/N) | 88 (79/90); P<0.001c | 29 (12/42) |
| Patients with sPGA-G ≥3 at baseline who achieved sPGA-G 0/1, % (n/N) | 78 (64/82); P<0.001c | 38 (15/40) |
| Patients with i-IGA ≥3 at baseline who achieved i-IGA 0/1, % (n/N) | 86 (96/111); P<0.001c | 29 (15/52) |
| Patients who achieved ≥4 point improvement in PSSD itch score from baseline, % (n/N) | 62.7 (126/201); P<0.001a,d | 12.5 (13/104) |
| Change from baseline in PSSD total symptom score, LS mean (n) | -36.1 (n=220) P<0.001e | 0.37 (n=112) |
| Patients who achieved a PSSD total symptom score of 0, % (n/N) | 21.9 (49/224) P<0.001a,f | 2.7 (3/112) |
| Abbreviations: CMH, Cochran-Mantel-Haenszel; BSA, body surface area; f-IGA, facial investigator’s global assessment; IGA, investigator’s global assessment; i-IGA, intertriginous investigator’s global assessment; LS Mean, least squares mean; MMRM, Mixed-Effect Model Repeated Measures; NRI, nonresponder imputation; PASI, psoriasis area and severity index; PsO, psoriasis; PSSD, psoriasis symptoms and signs diary; sPGA-G, static physician’s global assessment of genitalia. aP-values are based on CMH test stratified by special site (scalp, face, intertriginous, genital). Non-responder imputation was used; patients who discontinued study agent due to lack of efficacy, worsening of PsO, or use of a prohibited PsO treatment prior to designated visit were considered nonresponders from that point forward. Patients with missing data were considered non-responders. bP-value were based on MMRM with explanatory variables of treatment group, visit, baseline score, special site, an interaction term of visit with treatment group, and an interaction term of visit with baseline score. When participants discontinued study agent due to lack of efficacy, worsening of PsO, or use of prohibited PsO treatment, zero change was assigned from that point onward. Missing data was handled by MMRM under missing at random assumption. cP-values are based on the chi-squared test, not adjusted for baseline stratification factor. NRI was used; patients who discontinued study agent due to lack of efficacy, worsening of PsO, or use of a prohibited PsO treatment prior to designated visit, and were considered nonresponders from that point forward. Patients with missing data were considered non-responders.dAmong patients with a PSSD itch score ≥4 at baselineeP-value were based on MMRM with explanatory variables of treatment group, visit, baseline score, special site, an interaction term of visit with treatment group, and an interaction term of visit with baseline score. Negative change indicates improvement, and a positive change indicates worsening of disease. When participants discontinued study agent due to lack of efficacy, worsening of PsO, or use of prohibited PsO treatment, zero change was assigned from that point onward. Missing data was handled by MMRM under missing at random assumption.fAmong patients with a PSSD symptom score >0 at baseline | ||
Safety2
- Through week 16, 37.8% (85/225) of patients receiving TREMFYA and 39.8% (45/113) of patients receiving placebo reported ≥1 adverse event (AE).
- At least 1 serious adverse event was reported in 1.3% (3/225) of patients in the TREMFYA group compared to 0.9% (1/113) patients in the placebo group.
- Infection was reported in 22.2% (50/225) of patients receiving TREMFYA and 20.4% (23/113) of patients receiving placebo.
- At least 1 serious infection was reported in 0.9% (1/113) of patients in the placebo group compared to 0 in the TREMFYA group.
- At least 2.7% (6/225) of patients receiving TREMFYA reported ≥1 injection site reaction compared to 0.9% (1/113) of patients in the placebo group.
- Major adverse cardiovascular event was reported in 0.4% (1/225) of patients in the TREMFYA group compared to 0 events reported in the placebo group.
- Through week 16, no death, malignancies, active tuberculosis, inflammatory bowel disease, anaphylaxis, or serum-like sickness were reported in either group.
LITERATURE SEARCH
A literature search of MEDLINE®
References
| 1 | Janssen Research & Development, LLC. Study of guselkumab versus placebo for the treatment of low body surface area moderate plaque psoriasis (SPECTREM). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2024 October 17]. Available from: https://clinicaltrials.gov/study/NCT06039189 |
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