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TREMFYA® (guselkumab)
Medical Information
TREMFYA - Overview of SPECTREM Clinical Trial
Last Updated: 01/29/2026
SPECTREM (NCT06039189) is a multicenter, double-blind, randomized, phase 3b clinical trial that evaluated the safety and efficacy of TREMFYA compared with placebo (PBO) 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 (74.2%) compared to the PBO group (12.4%; 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 (74.2%) compared to the PBO group (12.4%; P<0.001).2
- A study evaluated the efficacy of TREMFYA based on mean percentage improvements from baseline in the Psoriasis Area and Severity Index (PASI), BSA×IGA, and BSA through week 48 in patients from SPECTREM.3
- Through week 48, PASI, BSA×IGA, and BSA improved by >90% in patients treated with TREMFYA.
- Safety results through week 56 were consistent with the known safety profile of TREMFYA. No new safety signals were identified.
- A study evaluated the efficacy of TREMFYA based on high-impact site skin clearance and itch improvement through week 48 in patients from SPECTREM.4
- At week 48, >80% of patients treated with TREMFYA achieved IGA/Physician Global Assessment (PGA) 0/1 at high-impact sites; 50% of patients treated with TREMFYA achieved site-specific IGA/PGA 0 in 6-10 weeks.
- The mean Psoriasis Symptoms and Signs Diary (PSSD) itch score in patients treated with TREMFYA improved from baseline (6.7) to week 48 (1.7).
- Safety results through week 56 were consistent with the known safety profile of TREMFYA. No new safety signals were identified.
- A study evaluated the efficacy of TREMFYA based on patient-reported outcomes (PROs), including Dermatology Life Quality Index (DLQI) and PSSD total symptoms score and individual symptom scores through week 48 in patients from SPECTREM. The association between PSSD 0 and IGA 0 was also explored.5
- At week 48, >60% of patients treated with TREMFYA achieved DLQI 0/1, indicating that PsO had no effect on quality of life; >3 out of 10 TREMFYA-treated patients achieved PSSD total symptoms score of 0.
- The mean PSSD total symptoms score and individual symptom scores decreased from baseline to week 48.
- The Spearman correlation coefficient (rs) between PSSD and IGA scores at week 48 was 0.5004 (P<0.0001).
- A study evaluated the efficacy of TREMFYA based on the response rates for IGA and PASI and the time to response for IGA through week 48 in patients from SPECTREM.6
- At week 48, ~70-80% of patients treated with TREMFYA achieved IGA 0/1 and ≥90% improvement in Psoriasis Area and Severity Index from baseline (PASI 90); ~50% of patients treated with TREMFYA achieved IGA 0 and 100% improvement in Psoriasis Area and Severity Index from baseline (PASI 100).
- Overall, 50% of TREMFYA-treated patients achieved IGA 0/1 in 6.7 weeks and IGA 0 in 17.1 weeks.
- Safety results through week 56 were consistent with the known safety profile of TREMFYA. No new safety signals were identified.
CLINICAL Data
Gold et al (2025),2 Gottlieb et al (2024),7
Study Design/Methods
- The study design and the outcomes measures are described in Figure: SPECTREM Study Design.1,
2
Note: Additional detail regarding study outcome definitions can be found on clinicaltrials.gov.
Abbreviations: BSA, body surface area; DLQI, Dermatology life quality index; f-IGA, facial Investigator’s Global Assessment; genital-PGA-genital physician global assessment; IGA, Investigator’s Global Assessment; i-IGA, intertriginous Investigator’s Global Assessment; PASI, Psoriasis Area and Severity Index; PASI 90, > 90% improvement in Psoriasis Area and Severity Index; PASI 100, 100% improvement in Psoriasis Area and Severity Index; PBO, placebo; PGA, Physician’s global assessment; PsA, Psoriatic Arthrtis; PsO, Psoriasi; PSSD, Psoriasis Symptoms and Signs Diary; sPGA-G, static Physician’s Global Assessment of Genitalia; ss-IGA, scalp-specific Investigator’s Global Assessment.
Results
Patient Characteristics
- A total of 338 patients were randomized in a 2:1 ratio to receive TREMFYA 100 mg (n=225) or PBO (n=113) subcutaneous (SC) at weeks 0 and 4 and then q8w, with PBO crossover to TREMFYA at week 16.2
- Overall, 94.1% of patients (318/338) completed the 16-week treatment period and continued in the study. Baseline characteristics are described in Table: Baseline Demographics and Clinical Characteristics.
Baseline Demographics and Clinical Characteristics2
| Characteristics | TREMFYA (n=225) | PBO (n=113) | Total (N=338) |
|---|---|---|---|
| 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) |
| Race, n (%) | |||
| White | 166 (73.8) | 83 (73.5) | 249 (73.7) |
| Asian | 16 (7.1) | 7 (6.2) | 23 (6.8) |
| Black or African American | 10 (4.4) | 3 (2.7) | 13 (3.8) |
| American Indian or Alaska Native | 3 (1.3) | 2 (1.8) | 5 (1.5) |
| Middle Eastern | 4 (1.8) | 0 | 4 (1.2) |
| Pacific Islander or Native Hawaiian | 2 (0.9) | 0 | 2 (0.6) |
| Multiracial/multiple | 9 (4.0) | 6 (5.3) | 15 (4.4) |
| Other | 15 (6.7) | 12 (10.6) | 27 (8.0) |
| Ethnicity, n (%) | |||
| Hispanic or Latino | 32 (14.2) | 20 (17.7) | 52 (15.4) |
| Not Hispanic or Latino | 193 (85.8) | 93 (82.3) | 286 (84.6) |
| BMI, kg/m2, mean (SD) | 30.9 (7.5) | 31.0 (7.5) | 30.9 (7.5) |
| Weight, kg, mean (SD) | 88.4 (22.4) | 87.4 (20.6) | 88.1 (21.8) |
| PsO disease duration, years, mean (SD) | 18.4 (14.9) | 14.0 (11.9) | 16.9 (14.1) |
| Age at PsO diagnosis, years, mean (SD) | 28.6 (17.5) | 30.5 (16.9) | 29.2 (17.3) |
| IGA, moderate (3), n (%) | 224 (99.6)a | 113 (100) | 337 (99.7)a |
| BSA, %, mean (SD) | 7.6 (3.7) | 7.5 (3.7) | 7.6 (3.7) |
| BSA category, n (%) | |||
| ≥2% to <5% | 65 (28.9) | 34 (30.1) | 99 (29.3) |
| ≥5% to <10% | 90 (40.0) | 47 (41.6) | 137 (40.5) |
| ≥10% to 15% | 70 (31.1) | 32 (28.3) | 102 (30.2) |
| PASI (0-72), mean (SD) | 9.1 (3.8) | 9.0 (3.9) | 9.0 (3.8) |
| 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) |
| DLQI, 0-30b | 11.4 (7.0) | 11.9 (6.0) | 11.5 (6.7) |
| Patient-reported outcomes, mean (SD) | |||
| PSSD symptom score (0-100)b | 53.3 (23.7) | 54.9 (22.0) | 53.8 (23.2) |
| PSSD itch score (0-10)b | 6.7 (2.2) | 6.8 (2.0) | 6.8 (2.2) |
| Previous treatments, n (%) | |||
| Topical agents | 225 (100) | 113 (100) | 338 (100) |
| Phototherapyc,d | 46 (20.5) | 16 (14.3) | 62 (18.5) |
| Conventional systemicse,f | 31 (13.8) | 15 (13.4) | 46 (13.7) |
| Advanced oralse,f | 11 (4.9) | 4 (3.6) | 15 (4.5) |
| Abbreviations: BMI, body mass index; BSA, body surface area; DLQI, Dermatology Life Quality Index; IGA, Investigator’s Global Assessment; PASI, Psoriasis Area and Severity Index; PBO, placebo; PsO, 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. bPBO, n=112; Total, N=337. c d e f | |||
Efficacy
At week 16, the primary endpoint of IGA 0/1 was achieved by significantly more patients receiving TREMFYA vs PBO (74.2% vs 12.4%, P<0.001).2 - At week 16, site-specific complete clearance was achieved by majority of patients treated with TREMFYA vs PBO (P<0.001)2:
- scalp-specific Investigator’s Global Assessment (ss-IGA) 0, 60.3% (111/184)
- facial Investigator’s Global Assessment (f-IGA) 0, 75.7% (103/136)
- intertriginous Investigator’s Global Assessment (i-IGA) 0, 76.6% (105/137)
- static Physician’s Global Assessment of Genitalia (sPGA-G) 0, 72.7% (72/99)
- Major secondary endpoints are described in Table: Major Secondary Endpoints at Week 16.
| TREMFYA | PBO | |
|---|---|---|
| Patients who achieved PASI 90, % (n/N) | 52.9 (119/225); P<0.001a | 6.2 (7/113) |
| Patients who achieved IGA 0, % (n/N) | 40.4 (91/225); P<0.001a | 3.5 (4/113) |
| Patients who achieved PASI 100, % (n/N) | 32.4 (73/225); P<0.001a | 2.7 (3/113) |
| Improvement from baseline PASI, LS mean (n) | 82.6 (n=220); P<0.001b | 13.7 (n=113) |
| Improvement from baseline BSA, LS mean (n) | 80.6 (n=220); P<0.001b | 6.1 (n=113) |
| Proportion of patients achieving an IGA 0/1 by baseline BSA | ||
| Baseline BSA ≥10 to 15, n (%) | 70 (77.1) | 32 (15.6) |
| Baseline BSA ≥5 to <10, n (%) | 90 (72.2) | 47 (10.6) |
| Baseline BSA ≥2 to <5, n (%) | 65 (73.8) | 34 (11.8) |
| Patients with ss-IGA ≥3 at baseline who achieved ss-IGA 0/1, % (n/N) | 75.0 (114/152); P<0.001c | 14.5 (11/76) |
| Patients with f-IGA ≥3 at baseline who achieved f-IGA 0/1, % (n/N) | 87.8 (79/90); P<0.001c | 28.6 (12/42) |
| Patients with sPGA-G ≥3 at baseline who achieved sPGA-G 0/1, % (n/N) | 78.0 (64/82); P<0.001c | 37.5 (15/40) |
| Patients with i-IGA ≥3 at baseline who achieved i-IGA 0/1, % (n/N) | 86.5 (96/111); P<0.001c | 28.8 (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) |
| DLQI 0/1, % | 48.9 | 3.5 |
| Abbreviations: BSA, body surface area; CMH, Cochran-Mantel-Haenszel; DLQI, Dermatology Life Quality Index; 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; PBO, placebo; PASI 90, > 90% improvement in Psoriasis Area and Severity Index; PASI 100, 100% improvement in Psoriasis Area and Severity Index; PsO, psoriasis; PSSD, Psoriasis Symptoms and Signs Diary; sPGA-G, static Physician’s Global Assessment of Genitalia; ss-IGA, scalp-specific Investigator’s Global Assessment. aP-values are based on CMH test stratified by special site (scalp, face, intertriginous, genital). 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 were considered nonresponders from that point forward. Patients with missing data were considered nonresponders. bP-value were based on MMRM with explanatory variables of treatment group, visit, baseline score, high-impact site, an interaction term of visit with treatment group, and an interaction term of visit with baseline score. When patients 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 were considered nonresponders from that point forward. Patients with missing data were considered nonresponders. dAmong patients with a PSSD itch score ≥4 at baseline eP-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 patients 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 | ||
Safety
- Through week 16, 37.8% (85/225) of patients receiving TREMFYA and 39.8% (45/113) of patients receiving PBO reported ≥1 adverse event.2 For details, see Table: Cumulative Rates of Key Safety Events through Week 16.
| TREMFYA (n=225) | Placebo (n=113) | |
|---|---|---|
| Mean duration of follow-up, weeks | 15.9 | 15.8 |
| Mean number of study agent administrations | 2.9 | 2.9 |
| ≥1 AE, n (%) | 85 (37.8) | 45 (39.8) |
| ≥1 SAE, n (%) | 3 (1.3)a | 1 (0.9) |
| AE leading to study drug discontinuation, n (%) | 0 | 4 (3.5) |
| Common AEs, n (%)b | ||
| Upper respiratory tract infection | 16 (7.1) | 3 (2.7) |
| Nasopharyngitis | 8 (3.6) | 8 (7.1) |
| AEs of interest, n (%) | ||
| Infections | 50 (22.2) | 23 (20.4) |
| Serious infections | 0 | 1 (0.9) |
| Injection site reactions | 6 (2.7) | 1 (0.9) |
| AEs of PsOc | 0 | 3 (2.7) |
| MACEd | 1 (0.4) | 0 |
| AEs leading to death | 0 | 0 |
| IBDe | 0 | 0 |
| Malignancy | 0 | 0 |
| Serum-like sickness or anaphylaxis | 0 | 0 |
| Tuberculosis | 0 | 0 |
| Abbreviations: AE, adverse event; IBD, inflammatory bowel disease; MACE, major adverse cardiovascular event; PsO, psoriasis; SAE, serious adverse event. aOne event each of upper limb fracture, renal colic, and cerebrovascular accident. bOccurred in at least 5% of patients in any treatment group through week 16. cIncludes preferred terms of dermatitis psoriasiform, erythrodermic PsO, genital PsO, PsO, PsO aggravated, exacerbation of PsO, PsO flare-up, psoriatic plaque, plaque PsO, and pustular PsO. dIncludes myocardial infarction and ischemic central nervous system vascular conditions. eIncludes preferred terms of Crohn’s disease, ulcerative colitis, and IBD. | ||
Gold et al (2025)3 evaluated the efficacy of TREMFYA based on mean percentage improvements in PASI, BSA×IGA, and BSA through week 48 in patients with low BSA, moderate PsO with high-impact site involvement in SPECTREM.
Results
Efficacy
In patients treated with TREMFYA, PASI, BSA×IGA, and BSA improved by >90% through week 48. Mean percentage improvements through week 48 are described in Table: Mean Percentage Improvement in PASI, BSA×IGA, and BSA through Week 48.
| Mean % Improvement from Baseline | Week 16 | Week 48 | ||||
|---|---|---|---|---|---|---|
| PBO (n=107) | PBO→ TREMFYA (n=107) | TREMFYA (n=218) | PBO | PBO→ TREMFYA (n=100) | TREMFYA (n=207) | |
| PASI | 13.6 | - | 82.6a | - | 86.8 | 90.4 |
| BSA×IGA | 8.9 | - | 87.4b | - | 89.0 | 94.1 |
| BSA | 5.6 | - | 80.5a | - | 85.6 | 90.0 |
| Note: Zero change from baseline was assigned after patients discontinued the study drug due to lack of efficacy, worsening of PsO, or use of a prohibited PsO treatment. Missing data were not explicitly imputed and were accounted for in the MMRM under a missing-at-random assumption. For patients who were randomized to PBO at week 0, only those patients who crossed over to TREMFYA at or after week 16 were included in the PBO→TREMFYA group. Abbreviations:BSA, body surface area; IGA, Investigator’s Global Assessment; MMRM, mixed-model for repeated measures; PASI, Psoriasis Area and Severity Index; PBO, placebo; PsO, psoriasis. aP<0.001 vs PBO based on the MMRM; explanatory variables included treatment group, visit, baseline score, high-impact site, and interaction terms of visit with treatment group and baseline score. bNominal P<0.001 vs PBO based on the MMRM. The endpoint was not controlled for multiple comparisons. Therefore, the P-value is nominal and statistical significance has not been established; explanatory variables included treatment group, visit, baseline score, high-impact site, and interaction terms of visit with treatment group and baseline score. | ||||||
- TREMFYA was well tolerated; safety results through week 56 were consistent with the known safety profile of TREMFYA. No new safety signals were identified. For more details,
see Table: Safety Results through Week 56.
| PBO→TREMFYA (Weeks 16-56; n=104)a | TREMFYA (Weeks 0-56; (n=225) | |
|---|---|---|
| Mean follow-up duration, weeks | 38.5 | 53.4 |
| ≥1 AE, n (%) | 56 (53.8) | 138 (61.3) |
| AEs leading to discontinuation of the study drug, n (%) | 1 (1.0) | 4 (1.8) |
| Serious AEs, n (%) | 2 (1.9) | 12 (5.3) |
| AEs of interest, n (%) | ||
| Infections | 42 (40.4) | 85 (37.8) |
| Serious infections | 1 (1.0)b | 2 (0.9)c |
| MACEd | 0 | 4 (1.8)e |
| Malignancyf | 0 | 2 (0.9)f |
| NMSCf | 0 | 2 (0.9)f |
| Excluding NMSC | 0 | 0 |
| VTE | 0 | 1 (0.4)g |
| Serum-like sickness or anaphylaxis | 0 | 0 |
| Active tuberculosis | 0 | 0 |
| Inflammatory bowel disease | 0 | 0 |
| Note: Patients were counted only once for any given event, regardless of the number of times they experienced the event. AEs were coded using MedDRA Version 27.1. Abbreviations: AE, adverse event; MACE, major adverse cardiovascular event; MedDRA, Medical dictionary for regulatory activities; NMSC, nonmelanoma skin cancer; PBO, placebo; VTE, venous thromboembolism. aPBO→TREMFYA column only includes PBO patients who crossed over to receive TREMFYA. bOne patient had appendicitis. cOne patient had pelvic abscess, and 1 patient had acute osteomyelitis of the cervical spine and sepsis. dIncludes myocardial infarction and ischemic central nervous system vascular conditions. eDuring weeks 0-16, 1 patient had a cerebrovascular accident; from weeks 16-56, myocardial infarction, coronary artery occlusion, and unstable angina were reported in 1 patient each. fIncludes 2 patients with basal cell carcinoma. gOne patient had bilateral pulmonary embolism. | ||
Strober et al (2025)4 evaluated the efficacy of TREMFYA based on high-impact site skin clearance and itch improvement through week 48 in patients with low BSA, moderate PsO in SPECTREM.
Results
Efficacy
More than 80% of TREMFYA-treated patients achieved IGA/PGA 0/1 at high-impact sites at week 48.4 - The response rates for site-specific IGA/PGA with TREMFYA were either maintained or increased through week 48.4 For details, see Table: Response Rates for Site-Specific IGA/PGA through Week 48.
| Response Rate at Week 16, % | Response Rate at Week 48, % | |||
|---|---|---|---|---|
| TREMFYA | PBO | TREMFYA | ||
| ss-IGA 0/1a | 75.0e | 14.5 | 84.9 | 78.6 |
| f-IGA 0/1b | 87.8e | 28.6 | 86.7 | 89.7 |
| i-IGA 0/1c | 86.5e | 28.8 | 91.9 | 83.7 |
| sPGA-G 0/1d | 78.0e | 37.5 | 84.1 | 78.4 |
| Note: P-value is based on the chi-squared test and not adjusted for baseline stratification factor. NRI was used. Patients who discontinued the study agent due to lack of efficacy, worsening of PsO, or use of a prohibited PsO treatment prior to the designated visit were considered nonresponders from that point forward. Patients with missing data were considered nonresponders. For patients who were randomized to PBO at week 0, only those patients who crossed over to TREMFYA at or after week 16 were included in the PBO→TREMFYA group. Abbreviations: f-IGA, facial Investigator’s Global Assessment; f-IGA 0/1 (clear or minimal) and 0 (clear); IGA, Investigator’s Global Assessment; IGA 0= cleared; IGA 1=minimal; i-IGA, intertriginous Investigator’s Global Assessment; i-IGA 0/1 (clear/minimal) and 0 (clear); NRI,nonresponder imputation; PBO, placebo; PGA, Physician’s Global Assessment; PsO, psoriasis; sPGA-G, static Physician’s Global Assessment of Genitalia; sPGA-G 0/1 (clear/minimal) and 0 (clear); ss-IGA, scalp-specific Investigator’s Global Assessment; .ss-IGA 0, absence of disease; ss-IGA 1, very mild disease aTREMFYA, n=152; PBO, n=76; PBO→TREMFYA, n=70. bTREMFYA, n=90; PBO, n=42; PBO→TREMFYA, n=39. cTREMFYA, n=111; PBO, n=52; PBO→TREMFYA, n=49. dTREMFYA, n=82; PBO, n=40; PBO→TREMFYA, n=37. eP<0.001 TREMFYA vs PBO. | ||||
- More than 70% of TREMFYA-treated patients achieved ss-IGA 0 and f-IGA 0; >75% of TREMFYA-treated patients achieved i-IGA 0 and sPGA-G 0.4
- The response rates for site-specific IGA/PGA with TREMFYA were either maintained or increased through week 48. For details, see Table: Response Rates for Site-Specific IGA/PGA through Week 48.
| Response Rate at Week 16, % | Response Rate at Week 48, % | |||
|---|---|---|---|---|
| TREMFYA | PBO | TREMFYA | PBO→TREMFYA | |
| ss-IGA 0a | 55.9e | 6.6 | 75.0 | 67.1 |
| f-IGA 0b | 80.0e | 16.7 | 78.9 | 79.5 |
| i-IGA 0c | 73.0e | 21.2 | 85.6 | 81.6 |
| sPGA-G 0d | 70.7e | 32.5 | 79.3 | 75.7 |
| Note: P-value is based on the chi-squared test and not adjusted for baseline stratification factor. NRI was used. Patients who discontinued the study agent due to lack of efficacy, worsening of PsO, or use of a prohibited PsO treatment prior to the designated visit were considered nonresponders from that point forward. Patients with missing data were considered nonresponders. For patients who were randomized to PBO at week 0, only those patients who crossed over to TREMFYA at or after week 16 were included in the PBO→TREMFYA group. Abbreviations: f-IGA, facial Investigator’s Global Assessment; f-IGA 0/1 (clear or minimal) and 0 (clear); IGA, Investigator’s Global Assessment; i-IGA, intertriginous Investigator’s Global Assessment; i-IGA 0/1 (clear/minimal) and 0 (clear); PBO, placebo; PGA, Physician’s Global Assessment; PsO, psoriasis; sPGA-G, static Physician’s Global Assessment of Genitalia; ss-IGA, scalp-specific Investigator’s Global Assessment;. ss-IGA 0, absence of disease; ss-IGA 1, very mild disease. aTREMFYA, n=152; PBO, n=76; PBO→TREMFYA, n=70. bTREMFYA, n=90; PBO, n=42; PBO→TREMFYA, n=39. cTREMFYA, n=111; PBO, n=52; PBO→TREMFYA, n=49. dTREMFYA, n=82; PBO, n=40; PBO→TREMFYA, n=37. eNominal P<0.001 for TREMFYA vs PBO. The endpoint was not controlled for multiple comparisons. Therefore, the P-value is nominal and statistical significance has not been established | ||||
- Overall, 50% of patients treated with TREMFYA achieved site-specific IGA/PGA 0 in 6-10 weeks.4
- ss-IGA 0 (n=184): 10.0 weeks
- f-IGA 0 (n=136): 6.4 weeks
- i-IGA 0 (n=137): 7.1 weeks
- sPGA-G 0 (n=99): 9.1 weeks
- The mean PSSD itch score showed a meaningful 5-point improvement in TREMFYA-treated patients; the response rates with TREMFYA were either maintained or improved through week 48. For details, see Table: Mean PSSD Itch Score and Total Symptoms Score through Week 48.
| Week 16 | Week 48 | |||||
|---|---|---|---|---|---|---|
| PBO (n=106) | PBO→ TREMFYA (n=106) | TREMFYA (n=218) | PBO | PBO→ TREMFYA (n=99) | TREMFYA (n=207) | |
| PSSD itch score | 6.6 | - | 2.6 | - | 2.3 | 1.7 |
| PSSD itch score (mean change from baseline) | - | -0.2 | -4.1a | - | -4.5 | -5.0 |
| PSSD total symptoms score | 53.8 | - | 17.4 | - | 14.8 | 12.3 |
| PSSD total symptoms score (mean change from baseline) | -0.5 | - | -35.5 | - | -39.7 | -40.9 |
| PSSD pain score | 4.7 | 1.3 | - | 1.1 | 1.0 | |
| PSSD pain score (mean change from baseline) | - | - | -3.5 | - | -3.6 | -3.8 |
| PSSD stinging Score | 5.0 | - | 1.4 | - | 1.2 | 1.1 |
| PSSD stinging Score (mean change from baseline) | -0.1 | - | -3.1a | - | -3.7 | -3.4 |
| PSSD burning score | 4.9 | - | 1.4 | - | 1.2 | 1.0 |
| PSSD burning score (mean change from baseline) | 0.0 | - | -3.2a | - | -3.8 | -3.7 |
| PSSD skin tightness score | 5.7 | - | 1.9 | - | 1.6 | 1.4 |
| PSSD skin tightness score (mean change from baseline) | -0.2 | - | -4.0a | - | -4.3 | -4.5 |
| Note: P-value is based on the MMRM with treatment group, visit, baseline score, high-impact site (scalp, face, intertriginous, genital), an interaction term of visit with treatment group, and an interaction term of visit with baseline score as explanatory variables. NRI used: patients who discontinued the study agent due to lack of efficacy, worsening of PsO, or use of a prohibited PsO treatment prior to the designated visit were considered nonresponders from that point forward. Patients with missing data were accounted for in the analysis model. For patients who were randomized to PBO at week 0, only those patients who crossed over to TREMFYA at or after week 16 were included in the PBO→TREMFYA group. Abbreviations: NRI, nonresponder imputation; MMRM, mixed-model for repeated measures; PBO, placebo; PsO, psoriasis; PSSD, Psoriasis Symptoms and Signs Diary. aNominal P<0.001 for TREMFYA vs placebo. The endpoint was not controlled for multiple comparisons. Therefore, the P-value is nominal and statistical significance has not been established. | ||||||
For safety results through week 56, see Table: Safety Results through Week 56.
Armstrong et al (2025)5 evaluated the efficacy of TREMFYA based on PROs, including DLQI and PSSD total symptoms score and individual symptom scores through week 48 in patients with low BSA, moderate PsO in SPECTREM. They also explored the association between PSSD 0 and IGA 0.
Results
Efficacy
- At week 48, >60% of TREMFYA-treated patients achieved DLQI 0/1, indicating that PsO had no effect on quality of life.5
- At week 16, 110 out of 225 patients (49%) in the TREMFYA group and 4 out of 113 patients (4%) in the PBO group had DLQI 0/1, resulting to a difference of 45% between the 2 groups (95% confidence interval [CI], 38-53; P<0.001).
- At week 48, 137 out of 225 patients (61%) in the TREMFYA group and 66 out of 104 patients (63%) in the PBO→TREMFYA group had DLQI 0/1.
At week 48, >3 out of 10 TREMFYA-treated patients achieved PSSD total symptoms score of 0.5 - At week 16, 49 out of 224 patients (22%) in the TREMFYA group and 3 out of 112 patients (3%) in the PBO group had a PSSD score of 0, resulting to a difference of 19% between the 2 groups (95% CI, 13-25; P<0.001).
- At week 48, 75 out of 224 patients (33%) in the TREMFYA group and 36 out of 104 patients (35%) in the PBO→TREMFYA group had a PSSD score of 0.
- In TREMFYA-treated patients, the mean PSSD total symptoms score and individual symptom scores decreased from baseline to week 48.5
Correlation between PSSD and IGA scores at week 48 was 0.5004 (P<0.0001).5 - At week 48, among TREMFYA-treated patients with an IGA score of 0, 94 out of 185 (51%) had a PSSD score of 0.
- At week 48, among TREMFYA-treated patients with a PSSD score of 0, 94 out of 112 (84%) had an IGA score of 0.
Langley et al (2025)6
Results
Efficacy
- Approximately, 70% to 80% of TREMFYA-treated patients achieved IGA 0/1 and PASI 90, and 50% of TREMFYA-treated patients achieved IGA 0 and PASI 100.6
- The response rates for IGA/PASI with TREMFYA increased through week 48. For more details, see Table: Response Rates for IGA/PASI through Week 48.6
| Response Rate at Week 16, % | Response Rate at Week 48, % | |||
|---|---|---|---|---|
| TREMFYA (n=225) | PBO (n=113) | TREMFYA (n=225) | PBO→TREMFYA (n=104) | |
| IGA 0a/1b | 74.2c | 12.4 | 80.0 | 80.8 |
| IGA 0 | 40.4c | 3.5 | 53.8 | 61.5 |
| PASI 90 | 52.9c | 6.2 | 68.4 | 71.2 |
| PASI 100 | 32.4c | 2.7 | 46.7 | 53.8 |
| Note: P-value is based on the CMH test stratified by high-impact site (scalp, face, intertriginous, genital). NRI was used. Patients who discontinued the study agent due to lack of efficacy, worsening of PsO, or use of a prohibited PsO treatment prior to the designated visit were considered nonresponders from that point forward. Patients with missing data were considered nonresponders. For patients who were randomized to PBO at week 0, only those patients who crossed over to TREMFYA at or after week 16 were included in the PBO→TREMFYA group. The observed differences in clearance as assessed by IGA 0 and PASI 100 reflects a limitation of the IGA (rounded to the nearest whole number). Abbreviations: CMH, Cochran-Mantel-Haenszel; IGA, Investigator’s Global Assessment; IGA 0= cleared; IGA 1=minimal; NRI,nonresponder imputation; PASI, Psoriasis Area and Severity Index; PASI 90, > 90% improvement in Psoriasis Area and Severity Index; PASI 100, 100% improvement in Psoriasis Area and Severity Index; PBO, placebo; PsO, psoriasis. aIGA 0=cleared. bIGA 1=minimal. cP<0.001 TREMFYA vs PBO. | ||||
Overall, 50% of TREMFYA-treated patients achieved IGA 0/1 in 6.7 weeks and IGA 0 in 17.1 weeks.6
Safety
- For safety results through week 56, see Table: Safety Results through Week 56.
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 2025 July 18]. Available from: https://clinicaltrials.gov/study/NCT06039189 NLM Identifier: NCT06039189. |
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