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TREMFYA® (guselkumab)

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Comparison to Secukinumab in the Treatment of Adults with Moderate to Severe Plaque Psoriasis

Last Updated: 01/04/2025

SUMMARY

ECLIPSE was a phase 3, multicenter, randomized, double-blind, comparator-controlled study comparing the efficacy and safety of TREMFYA and secukinumab for the treatment of adult patients with moderate to severe plaque psoriasis (PsO).¹
- At week 48, a ≥90% improvement in Psoriasis Area and Severity Index score (PASI 90) response was achieved by a significantly greater proportion of patients in the TREMFYA group (84%) than in the secukinumab group (70%) (P<0.0001).¹
- In efficacy analyses of subpopulations of the ECLIPSE study, the proportion of patients who achieved PASI 90, a 100% improvement in Psoriasis Area and Severity Index score (PASI 100), Investigator’s Global Assessment (IGA) 0, and IGA 0/1 response was numerically higher in the TREMFYA group than in the secukinumab group at week 48, regardless of previous PsO treatment, body weight, body mass index (BMI), age, disease severity, and affected body region.²
ARROW was a phase 2a, multicenter, 16-week, randomized, open-label, parallel-group, active-control study that compared the efficacy and safety of TREMFYA with that of secukinumab in adult patients with ustekinumab-refractory PsO.³
- At week 16, the percentage of patients whose ustekinumab-refractory target plaque PsO achieved a clear/almost clear status (primary endpoint) was 40.0% in the TREMFYA group and 60.0% in the secukinumab group (P=0.1715).
- In the efficacy analyses of exploratory endpoints of the ARROW study, both TREMFYA and secukinumab treatments resulted in a reduction of body surface area (BSA), PASI, IGA, total Nail Psoriasis Severity Index (NAPSI), finger NAPSI, Psoriasis Scalp Severity Index (PSSI), and Palmoplantar Investigator's Global Assessment (ppIGA) at week 16. All reductions were higher in the secukinumab group, except for PSSI.

CLINICAL Study

ECLIPSE

Reich et al (2019)¹ reported results from ECLIPSE, a head-to-head study of TREMFYA and secukinumab in 1048 adults with moderate to severe plaque PsO.

Study Design/Methods

Eligible patients (≥18 years of age) had moderate to severe plaque PsO (PASI ≥12, IGA score ≥3, BSA involvement ≥10% for ≥6 months) and were candidates for phototherapy or systemic therapy.
Patients were excluded if they had a history or current signs of a severe, progressive, or uncontrolled medical condition; had current or history of malignancy, except nonmelanoma skin cancer (NMSC) within 5 years; had history of inflammatory bowel disease; or had ever received: TREMFYA or secukinumab, any therapeutic agent directly targeted to interleukin (IL)-12/23p40, IL-17A, IL-17R, or IL-23 within 6 months of the first study drug injection, or any systemic immunosuppressants (eg, methotrexate) or phototherapy within 4 weeks of the first injection of study agent.
Patients were randomized at week 0 in a 1:1 ratio. The TREMFYA group received TREMFYA 100 mg subcutaneously (SC) at weeks 0, 4, 12, and every 8 weeks thereafter through week 44, and the secukinumab group received secukinumab 300 mg SC at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter through week 44.
Safety follow-up continued through week 56.
The primary endpoint was the proportion of patients who achieved a PASI 90 response at week 48 (noninferiority test followed by superiority).
The primary and major secondary endpoints were prespecified and tested in a fixed sequence to control for multiplicity (ie, multiple comparisons). Following a nonsignificant test for any endpoint (noninferiority or superiority), formal statistical testing was not conducted for the remaining endpoints in the testing hierarchy.
Patients who discontinued study agent due to lack of efficacy, an adverse event (AE) of PsO worsening, or started a protocol-prohibited treatment were considered nonresponders.
Missing data were imputed as nonresponse.
Major secondary endpoints included the proportion of patients who achieved: a ≥75% improvement in PASI from baseline (PASI 75) at both week 12 and week 48 (noninferiority test followed by superiority); a PASI 90 at week 12 (noninferiority); a PASI 75 at week 12 (noninferiority); a PASI 100 at week 48 (noninferiority test followed by superiority); an IGA score of cleared (0) at week 48 (noninferiority test followed by superiority); and an IGA score of cleared (0) or minimal (1) at week 48 (noninferiority test followed by superiority).

Results

Patient Characteristics

A total of 1048 patients were randomized to receive TREMFYA (n=534) or secukinumab (n=514).
Three patients in the secukinumab group were not treated because of violations of the inclusion or exclusion criteria; all other patients received their assigned treatment.
Through week 44, 5% (n=27) of TREMFYA-treated patients and 9% (n=48) of secukinumab-treated patients discontinued study agent.
- The most common reasons for discontinuation were AEs (2% [n=9] and 2% [n=11]) and patient withdrawal (1% [n=7] and 4% [n=19]) in the TREMFYA and secukinumab groups, respectively.
Baseline demographics and disease characteristics were comparable between the treatment groups.
The mean BSA involved was 24.1% and the mean PASI score was 20.0 at baseline.
At baseline an IGA score of moderate (3) and severe (4) were reported in 76% and 24% of patients, respectively.

Efficacy

At week 48, a PASI 90 response was achieved by a significantly greater proportion of patients in the TREMFYA group (84% [451/534]) than in the secukinumab group (70% [360/514]); treatment difference: 14.2 percentage points (95% confidence interval [CI], 9.2-19.2); P<0.0001 for both noninferiority and superiority.
Major secondary endpoints are described in Table: ECLIPSE Primary and Major Secondary Endpoints.
- For the first major secondary endpoint, PASI 75 at both week 12 and week 48, noninferiority of TREMFYA vs secukinumab was demonstrated (P<0.0001); however, superiority of TREMFYA vs secukinumab was not established (P=0.0616).
- Consequently, only summary statistics were provided for the remaining major secondary endpoints.

ECLIPSE Primary and Major Secondary Endpoints¹

	TREMFYA 100 mg (n=534) n (%)	Secukinumab 300 mg (n=514) n (%)	Noninferiority Test P-Value^a	Superiority Test P-Value^a
Primary endpoint
PASI 90 response at week 48^b,c	451 (84%)	360 (70%)	P<0.0001	P<0.0001
Major secondary endpoints
PASI 75 response at both week 12 and week 48^b,d	452 (85%)	412 (80%)	P<0.0001	P=0.0616
PASI 90 response at week 12^e	369 (69%)	391 (76%)	NA	NA
PASI 75 response at week 12^e	477 (89%)	471 (92%)	NA	NA
PASI 100 response at week 48^b	311 (58%)	249 (48%)	NA	NA
IGA score of 0 (cleared) at week 48^b	332 (62%)	259 (50%)	NA	NA
IGA score of 0 (cleared) or 1 (minimal) at week 48^b	454 (85%)	385 (75%)	NA	NA
Abbreviations: CI, confidence interval; IGA, Investigator’s Global Assessment; NA, not applicable; PASI, Psoriasis Area and Severity Index; PASI 75/90/100, ≥75/90/100% improvement from baseline in PASI. ^aTo control the overall type I error rate for multiple comparisons, primary and major secondary analyses were to be tested in a fixed-sequence; after a nonsignificant test for any endpoint, formal statistical testing was not done for subsequent endpoints. ^bSuperiority testing was prespecified to follow after noninferiority testing. ^cFor the per-protocol population, TREMFYA was noninferior to secukinumab for PASI 90 at week 48 (441 [88%] of 499 patients in the TREMFYA group vs 345 [76%] of 455 in the secukinumab group; treatment difference 12.4 percentage points, 95% CI, 7.6-17.3; P<0.0001 and the results were consistent with the noninferiority test based on the intention-to-treat population. ^dFor the per-protocol population, TREMFYA was noninferior to secukinumab for PASI 75 at both week 12 and week 48 (443 [89%] of 499 vs 394 [87%] of 455; treatment difference 2.3 percentage points, -1.9 to 6.6; P<0.0001 and the results were consistent with the noninferiority test based on the intention-to-treat population. ^eNoninferiority testing was prespecified.

PASI 90 results over time through week 48 are described in Figure: Proportion of Patients Achieving a PASI 90 Response Through Week 48 by Visit.
The time to achieve a median PASI improvement from baseline of 50% was 2.7 (95% CI, 2.6-2.9) weeks for TREMFYA vs 2.3 (95% CI, 2.2-2.4) weeks for secukinumab, and 8.2 (95% CI, 7.8-9.1) weeks vs 7.4 (95% CI, 7.0-7.5) weeks for a median PASI improvement of 90%.

Proportion of Patients Achieving a PASI 90 Response Through Week 48 by Visit⁴

Abbreviation: PASI 90, ≥90% improvement from baseline in PASI.

Regardless of prior PsO medication history, numerically greater proportions of patients receiving TREMFYA vs secukinumab achieved PASI 90, PASI 100, and IGA 0 responses at week 48 (Table: Proportions of Patients Who Achieved PASI 90, PASI 100, IGA 0, and IGA 0/1 Responses at Week 48 by Previous Baseline PsO Treatment).²^,⁵

Proportions of Patients Who Achieved PASI 90, PASI 100, IGA 0, and IGA 0/1 Responses at Week 48 by Previous Baseline PsO Treatment²^,⁵

	TREMFYA 100 mg^a(n=534)	Secukinumab 300 mg^b(n=514)	Treatment Difference (95% CI)
PASI 90
Phototherapy (PUVA or UVB)	85.4	68.6	16.8 (9.5-24.2)
Nonbiologic systemics^c	83.0	68.6	14.3 (7.0-21.6)
Biologics^d	81.4	64.4	17 (6.5-27.5)
Nonbiologic systemics or biologics^c,d	83.2	68.3	15 (8.2-21.7)
TNF-α inhibitors	76.8	58.8	18 (2.9-33.1)
IL-12/23 or IL-23 inhibitors	73.3	56.8	16.5 (-5.3 to 38.3)
IL-17 inhibitors	85.5	68.1	17.4 (2.2-32.6)
PASI 100
Phototherapy (PUVA or UVB)	57.7	48.7	9 (0.2-17.7)
Nonbiologic systemics^c	58.0	45.3	12.7 (4.1-21.2)
Biologics^d	59.0	47.0	12 (0.2-23.8)
Nonbiologic systemics or biologics^c,d	58.2	46.5	11.7 (3.8-19.6)
TNF-α inhibitors	57.3	42.4	15 (-1.2 to 31.2)
IL-12/23 or IL-23 inhibitors	55.6	40.9	14.6 (-8.1 to 37.4)
IL-17 inhibitors	59.4	52.2	7.2 (-10.7 to 25.2)
IGA 0
Phototherapy (PUVA or UVB)	61.6	49.8	3.1-20.4
Nonbiologic systemics^c	61.2	46.7	6.0-23.0
Biologics^d	60.9	47.7	1.5-25.0
Nonbiologic systemics or biologics^c,d	61.3	47.7	-1.9 to 18.7
TNF-α inhibitors	58.5	43.5	-1.2 to 31.2
IL-12/23 or IL-23 inhibitors	57.8	40.9	-5.9 to 39.6
IL-17 inhibitors	60.9	52.2	-9.2 to 26.6
IGA 0/1
Phototherapy (PUVA or UVB)	86.1	77.0	2.2-16.0
Nonbiologic systemics^c	85.1	76.3	2.0-15.7
Biologics^d	84.0	71.8	2.3-22.1
Nonbiologic systemics or biologics^c,d	84.8	75.5	2.9-15.6
TNF-α inhibitors	81.7	64.7	2.6-31.4
IL-12/23 or IL-23 inhibitors	77.8	63.6	-6.8 to 35.1
IL-17 inhibitors	87.0	75.4	-2.8 to 25.9
Data are presented as percentage, unless noted otherwise. Abbreviations: CI, confidence interval; IGA, Investigator’s Global Assessment; IL, interleukin; PASI, Psoriasis Area and Severity Index; PASI 90/100, ≥90/100% improvement from baseline in PASI; PsO, psoriasis; PUVA, psoralen plus ultraviolet A; TNF-α, tumor necrosis factor-alpha; UVB, ultraviolet B. ^aPhototherapy (PUVA or UVB), n=281; nonbiologic systemics, n=276; biologics, n=156; nonbiologic systemics or biologics, n=328; TNF-α inhibitors, n=82; IL-12/23 or IL-23 inhibitors, n=45; IL-17 inhibitors, n=69. ^bPhototherapy (PUVA or UVB), n=261; nonbiologic systemics, n=287; biologics, n=149; nonbiologic systemics or biologics, n=331; TNF-α inhibitors, n=85; IL-12/23 or IL-23 inhibitors, n=44; IL-17 inhibitors, n=69.^cIncludes PUVA, methotrexate, cyclosporine, acitretin, apremilast, and tofacitinib. ^dIncludes TNF-α inhibitors (etanercept, infliximab, adalimumab), IL-12/IL-23 inhibitors (ustekinumab, briakinumab), IL-23 inhibitors (tildrakizumab, risankizumab), IL-17 inhibitors (ixekizumab, brodalumab), alefacept, and efalizumab.

In efficacy analyses according to baseline body weight and BMI, the proportion of patients that achieved PASI 90, PASI 100, IGA 0, and IGA 0/1 responses was higher in the TREMFYA group than in the secukinumab group at week 48 across body weight and BMI categories (Table: Proportions of Patients Who Achieved PASI 90, PASI 100, IGA 0, and IGA 0/1 Responses at Week 48 by Baseline Body Weight and Table: Proportions of Patients Who Achieved PASI 90, PASI 100, IGA 0, and IGA 0/1 Responses at Week 48 by Baseline BMI Categories).²

Proportions of Patients Who Achieved PASI 90, PASI 100, IGA 0, and IGA 0/1 Responses at Week 48 by Baseline Body Weight²

Body Weight	TREMFYA 100 mg^a (n=534)	Secukinumab 300 mg^b (n=514)
PASI 90
60 kg	85.0	69.2
>60 to 70 kg	86.6	74.5
>70 to 80 kg	89.1	77.2
>80 to 90 kg	89.8	72.3
>90 to 100 kg	76.3	70.8
>100 to 110 kg	82.0	66.7
>110 kg	82.3	55.7
PASI 100
60 kg	50.0	46.2
>60 to 70 kg	64.2	58.2
>70 to 80 kg	65.2	57.6
>80 to 90 kg	64.3	46.2
>90 to 100 kg	56.7	51.0
>100 to 110 kg	57.4	44.4
>110 kg	44.3	32.8
IGA 0
≤60 kg	52.5	50.0
>60 to 70 kg	65.7	60.0
>70 to 80 kg	68.5	59.8
>80 to 90 kg	71.4	48.7
>90 to 100 kg	57.7	53.1
>100 to 110 kg	62.3	44.4
>110 kg	50.6	34.4
IGA 0/1
≤60 kg	77.5	76.9
>60 to 70 kg	85.1	74.5
>70 to 80 kg	90.2	79.3
>80 to 90 kg	91.8	79.8
>90 to 100 kg	79.4	81.3
>100 to 110 kg	78.7	69.8
>110 kg	86.1	55.7
Data are presented as percentage, unless noted otherwise. Abbreviations: IGA, Investigator’s Global Assessment; PASI, Psoriasis Area and Severity Index; PASI 90/100, ≥90/100% improvement from baseline in PASI. ^aResults were available for 534 patients in the TREMFYA group (60 kg, n=40; >60 to 70 kg, n=67; >70 to 80 kg, n=92; >80 to 90 kg, n=98; >90 to 100 kg, n=97; >100 to 110 kg, n=61; >110 kg, n=79). ^bResults were available for 512 patients in the secukinumab group (60 kg, n=26; >60 to 70 kg, n=55; >70 to 80 kg, n=92; >80 to 90 kg, n=119; >90 to 100 kg, n=96; >100 to 110 kg, n=63; >110 kg, n=61).

Proportions of Patients Who Achieved PASI 90, PASI 100, IGA 0, and IGA 0/1 Responses at Week 48 by Baseline BMI Categories²^,⁶

	TREMFYA 100 mg^a(n=534)	Secukinumab 300 mg^b(n=514)	Treatment Difference (95% CI)
PASI 90
Normal (<25 kg/m²)	88.1	75.2	12.8 (2.2-23.5)
Overweight (≥25 to <30 kg/m²)	84.1	73.4	10.6 (1.6-19.7)
Obese (≥30 kg/m²)	82.5	65.3	17.2 (8.8-25.6)
PASI 100
Normal (<25 kg/m²)	64.2	57.8	6.4 (-6.8 to 19.5)
Overweight (≥25 to <30 kg/m²)	61.4	53.7	7.7 (-3.2 to 18.5)
Obese (≥30 kg/m²)	52.5	40.4	12.0 (2.4-21.6)
IGA 0
Normal (<25 kg/m²)	68.7	60.6	-
Overweight (≥25 to <30 kg/m²)	64.2	54.2	-
Obese (≥30 kg/m²)	57.0	43.1	-
IGA 0/1
Normal (<25 kg/m²)	85.8	77.1	-
Overweight (≥25 to <30 kg/m²)	86.9	81.9	-
Obese (≥30 kg/m²)	83.0	69.3	-
Data are presented as percentage, unless noted otherwise. Abbreviations: BMI, body mass index; CI, confidence interval; IGA, Investigator’s Global Assessment; PASI, Psoriasis Area and Severity Index; PASI 90/100, ≥90/100% improvement from baseline in PASI. ^aResults were available for 533 patients in the TREMFYA group (normal, n=134; overweight, n=176; obese, n=223). ^bResults were available for 511 patients in the secukinumab group (normal, n=109; overweight, n=177; obese, n=225).

In efficacy analyses according to age categories, the proportion of patients who achieved PASI 90, PASI 100, IGA 0, and IGA 0/1 responses was higher in the TREMFYA group than in the secukinumab group at week 48 across all age groups (Table: Proportions of Patients Who Achieved PASI 90, PASI 100, IGA 0, and IGA 0/1 Responses at Week 48 by Age Categories).²

Proportions of Patients Who Achieved PASI 90, PASI 100, IGA 0, and IGA 0/1 Responses at Week 48 by Age Categories²

Age Categories	TREMFYA 100 mg^a (n=534)	Secukinumab 300 mg^b (n=514)
PASI 90
<45 years	85.4	75.2
45 to <65 years	84.3	68.6
≥65 years	81.5	46.7
PASI 100
<45 years	58.8	55.3
45 to <65 years	58.7	44.9
≥65 years	53.7	24.4
IGA 0
<45 years	64.6	58.0
45 to <65 years	61.4	46.4
≥65 years	55.6	24.4
IGA 0/1
<45 years	85.8	81.3
45 to <65 years	85.4	73.4
≥65 years	79.6	44.4
Data are presented as percentage, unless noted otherwise. Abbreviations: IGA, Investigator's Global Assessment; PASI, Psoriasis Area and Severity Index; PASI 90/100, ≥90/100% improvement from baseline in PASI. ^aResults were available for 534 patients in the TREMFYA group (<45 years, n=226; 45 to <65 years, n=254; ≥65 years, n=54). ^bResults were available for 514 patients in the secukinumab group (<45 years, n=262; 45 to <65 years, n=207; ≥65 years, n=45).

In efficacy analyses according to baseline disease severity, the proportion of patients that achieved PASI 90, PASI 100, IGA 0, and IGA 0/1 responses was higher in the TREMFYA group than in the secukinumab group at week 48 in all baseline disease severity subgroups (Table: Proportions of Patients Who Achieved PASI 90, PASI 100, IGA 0, and IGA 0/1 Responses According to Baseline Disease Severity at Week 48).²

Proportions of Patients Who Achieved PASI 90, PASI 100, IGA 0, and IGA 0/1 Responses According to Baseline Disease Severity at Week 48²

	TREMFYA 100 mg^a(n=534)	Secukinumab 300 mg^b(n=514)
PASI 90
Baseline BSA ≥20%	85.1	74.2
Baseline BSA 20%	83.9	66.4
Psoriasis duration of ≥15 years	86.0	75.7
Psoriasis duration of 15 years	83.3	65.1
Baseline PASI score ≥20	83.1	70.2
Baseline PASI score of 20	86.8	69.7
Baseline IGA score <4	84.5	69.1
Baseline IGA score of 4	84.3	73.0
PASI 100
Baseline BSA ≥20%	59.0	55.0
Baseline BSA 20%	57.5	42.7
Psoriasis duration of ≥15 years	58.1	55.2
Psoriasis duration of 15 years	58.3	42.5
Baseline PASI score ≥20	56.7	51.2
Baseline PASI score of 20	61.1	43.6
Baseline IGA score <4	60.2	49.0
Baseline IGA score of 4	52.0	46.7
IGA 0
Baseline BSA ≥20%	60.4	44.2
Baseline BSA <20%	64.3	57.5
Psoriasis duration of ≥15 years	61.2	44.4
Psoriasis duration of <15 years	63.5	57.3
Baseline PASI score ≥20	63.7	45.7
Baseline PASI score <20	61.3	53.1
Baseline IGA score <4	64.1	51.3
Baseline IGA score of 4	55.9	47.5
IGA 0/1
Baseline BSA ≥20%	84.2	69.7
Baseline BSA <20%	85.9	80.8
Psoriasis duration of ≥15 years	85.3	73.1
Psoriasis duration <15 years	84.7	77.0
Baseline PASI score ≥20	88.4	68.1
Baseline PASI score <20	83.1	78.8
Baseline IGA score <4	86.2	75.8
Baseline IGA score of 4	81.1	72.1
Data are presented as percentage, unless noted otherwise. Abbreviations: BSA, body surface area; IGA, Investigator’s Global Assessment; PASI, Psoriasis Area and Severity Index; PASI 90/100, ≥90/100% improvement from baseline in PASI. ^aResults were available for 534 patients in the TREMFYA group (baseline BSA ≥20%, n=249; baseline BSA 20%, n=285; psoriasis duration of ≥15 years, n=222; psoriasis duration of 15 years, n=312; baseline PASI score of ≥20, n=344; baseline PASI score of 20, n=190; baseline IGA score of <4, n=407; baseline IGA score of 4, n=127). ^bResults were available for 514 patients in the secukinumab group (baseline BSA ≥20%, n=240; baseline BSA 20%, n=274; psoriasis duration of ≥15 years, n=239; psoriasis duration of 15 years, n=275; baseline PASI score of ≥20, n=326; baseline PASI score of 20, n=188; baseline IGA score of <4, n=392; baseline IGA score of 4, n=122).

In efficacy analyses of patients with baseline PsO according to body region, the proportion of patients that achieved PASI 90 and PASI 100 responses was higher in the TREMFYA group than in the secukinumab group at week 48 in all body regions (Table: Proportions of Patients Who Achieved PASI 90 and PASI 100 Responses According to Body Region at Week 48).²

Proportions of Patients Who Achieved PASI 90 and PASI 100 Responses According to Body Region at Week 48²

Body Region	TREMFYA 100 mg^a(n=534)	Secukinumab 300 mg^b(n=514)
Head
PASI 90	85.0	77.1
PASI 100	80.0	74.8
Trunk
PASI 90	86.7	80.0
PASI 100	84.4	77.7
Upper extremities
PASI 90	81.8	66.9
PASI 100	79.3	63.1
Lower extremities
PASI 90	81.1	66.9
PASI 100	74.9	61.4
Data are presented as percentage, unless noted otherwise. Abbreviations: PASI, Psoriasis Area and Severity Index; PASI 90/100, ≥90/100% improvement from baseline in PASI. ^aResults were available for 534 patients in the TREMFYA group (head, n=499 [PASI 90, n=424; PASI 100, n=399]; trunk, n=512 [PASI 90, n=444; PASI 100, n=432]; upper extremities, n=532 [PASI 90, n=435; PASI 100, n=422]; lower extremities, n=534 [PASI 90, n=433; PASI 100, n=400]). ^bResults were available for 514 patients in the secukinumab group (head, n=481 [PASI 90, n=371; PASI 100, n=360]; trunk, n=494 [PASI 90, n=395; PASI 100, n=384]; upper extremities, n=510 [PASI 90, n=341; PASI 100, n=322]; lower extremities, n=513 [PASI 90, n=343; PASI 100, n=315]).

A subgroup analysis of PsO patients with and without baseline self-reported PsA status was conducted. Proportions of patients achieving PASI 90, PASI 100, IGA 0, and IGA 0/1 at week 48 are reported in Table: Proportions of Patients Achieving PASI 90, PASI 100, IGA 0, and IGA 0/1 Responses at Week 48.⁷

Proportions of Patients Achieving PASI 90, PASI 100, IGA 0, and IGA 0/1 Responses at Week 48⁷^a

	TREMFYA 100 mg^b(n=534)	Secukinumab 300 mg^c(n=514)	Treatment Difference (95% CI)
PASI 90
With PsA	82.5%	63.3%	19.2 (5.0-33.4)
Without PsA	84.9%	71.3%	13.6 (8.0-19.3)
PASI 100
With PsA	56.7%	44.3%	12.4 (-3.5 to 28.3)
Without PsA	58.6%	49.2%	9.4 (2.6-16.2)
IGA 0
With PsA	58.8%	45.6%	13.2 (-2.7 to 29.1)
Without PsA	62.9%	51.3%	11.7 (4.9-18.4)
IGA 0/1^d
With PsA	88.7%	73.4%	15.2 (2.5-28.0)
Without PsA	84.2%	75.2%	9 (3.5-14.6)
Data are presented as percentage, unless noted otherwise. Abbreviations: CI, confidence interval; IGA, Investigator’s Global Assessment; PASI, Psoriasis Area and Severity Index; PASI 90/100, ≥90/100% improvement from baseline in PASI; PsA, psoriatic arthritis. ^aNonresponder imputation was used for missing data after applying treatment failure rules. ^bResults were available for 534 patients in the TREMFYA group (with PsA, n=97; without PsA, n=437). ^cResults were available for 514 patients in the secukinumab group (with PsA, n=79; without PsA, n=435). ^dPost hoc analysis.

Safety

Key safety findings are summarized in Table: Key Safety Events Through Week 56.
No cases of active tuberculosis or opportunistic infections were reported during the study.

Key Safety Events Through Week 56¹

	TREMFYA 100 mg (n=534)	Secukinumab 300 mg (n=511)
Mean (standard deviation) duration of follow-up, weeks	54.9 (6.7)	53.7 (9.2)
Patients with ≥1 AE, n (%)	416 (78%)	417 (82%)
Common AEs, n (%)^a
Nasopharyngitis	118 (22%)	125 (24%)
Upper respiratory tract infection	83 (16%)	92 (18%)
Headache	49 (9%)	48 (9%)
Arthralgia	30 (6%)	25 (5%)
Back pain	29 (5%)	18 (4%)
Diarrhea	27 (5%)	20 (4%)
Discontinued study drug because of AE, n (%)	10 (2%)	12 (2%)
Patients with ≥1 serious AE, n (%)	33 (6%)	37 (7%)
Overall infections, n (%)	313 (59%)	331 (65%)
Requiring treatment	118 (22%)	147 (29%)
Serious infections	6 (1%)	5 (1%)
Candida infections, n (%)^b	12 (2%)	29 (6%)
Tinea infections, n (%)^c	9 (2%)	23 (5%)
Worsening of psoriasis, n (%)	4 (1%)	11 (2%)
Crohn’s disease, n (%)^d	0	3 (1%)
Malignancy, n (%)	7 (1%)	4 (1%)
NMSC^e	6 (1%)	2 (<1%)
Other malignancies^f	1 (<1%)	2 (<1%)
MACE, n (%)^g	0	1 (<1%)
Abbreviations: AE, adverse event; MACE, major adverse cardiovascular events; NMSC, nonmelanoma skin cancer. ^aOccuring in ≥5% of patients in any treatment group. ^bCandida infections included the AE terms: oral candidiasis, vulvovaginal candidiasis, skin candida, candida infection, balanitis candida, and vulvovaginal mycotic infection. ^cTinea infections included the AE terms: tinea pedis, tinea cruris, fungal skin infection, body tinea, dermatophytosis, and onychomycosis. ^dOne (<1%) was a new-onset AE of Crohn’s disease, and 1 (<1%) was an AE of worsening of Crohn’s disease in a patient who had not disclosed a history of Crohn’s disease at screening; all cases were established by colonoscopy. ^eNMSCs were basal cell carcinomas (n=3 [<1%] in the TREMFYA group, n=2 [<1%] in the secukinumab group) and squamous cell carcinomas (n=3 [<1%] in the TREMFYA group).^fOther malignancies were 1 breast cancer in the TREMFYA group, and 1 lung cancer and 1 mycosis fungoides in the secukinumab group. ^gMACE is defined as an investigator-reported nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death; the 1 MACE reported in the secukinumab group was a cerebrovascular accident.

ARROW

Krueger et al (2023)³ reported results from the ARROW study, which compared the efficacy and safety of TREMFYA with that of secukinumab in adult patients with ustekinumab-refractory psoriatic plaques.

Study Design/Methods

Eligible patients (aged ≥18 years) had inadequately controlled chronic plaque-type PsO (absolute PASI score of 1-10 and presence of ≥1 refractory skin plaque defined as total clinical score [TCS] of ≥6 and severity score of ≥2 or 3 (moderate) with an area of ≥10 cm² at screening and baseline) after treatment with ustekinumab. Patients had received ustekinumab at a dose equal to or higher than that on the label for ≥24 weeks. The last dose of ustekinumab was received ≥12 weeks before randomization.
- For all included patients, 1 refractory plaque was identified as the study "target plaque" to assess all outcomes of the treatment. TCS for the target plaque was calculated as the sum of erythema, scaling, and infiltration scores, rated according to severity (ranging from 0 [all signs absent] to 9 [all signs present]).
Patients were excluded if they had other forms of PsO (eg, pustular, erythrodermic, guttate, or drug-induced PsO); received cyclosporine or methotrexate or other systemic immunomodulatory treatment (except for nonsteroidal anti-inflammatory drugs) or other systemic PsO treatment (eg, retinoids, fumarates, apremilast) or photochemotherapy within 4 weeks before randomization; treated with phototherapy within 2 weeks of randomization; received any other biological immunomodulatory agent (eg, alefacept, briakinumab, efalizumab) within 6 months before randomization; received live virus vaccination within 6 weeks before randomization; were previously treated with >1 tumor necrosis factor-alpha (TNF-α) inhibitor or with IL-17A (including secukinumab), IL-17 receptor, or IL-23 (including TREMFYA) inhibitor; and involved in any interventional study within 4 weeks before randomization or half-lives whichever was longer.⁸
Patients were randomized at week 0 in a 1:1 ratio. The TREMFYA group received TREMFYA 100 mg SC at weeks 0, 4, and 12, and the secukinumab group received secukinumab 300 mg SC at weeks 0, 1, 2, 3, 4, 8, and 12.
The primary endpoint of this study was the proportion of patients whose ustekinumab-refractory target plaque achieved a "clear" or "almost clear" status (TCS of 0-2) at week 16 with either TREMFYA or secukinumab.
Additional exploratory endpoints were change from baseline to week 16 in joint pain (score based on a visual analog scale [VAS] 0-100), absolute PASI score, BSA, IGA, NAPSI, PSSI, and ppIGA.

Results

Patient Characteristics

A total of 40 ustekinumab-refractory patients were randomized to receive TREMFYA (n=20) or secukinumab (n=20).
One patient from the TREMFYA group discontinued due to the physician’s decision.
Baseline demographics and disease characteristics were comparable between the treatment groups.
At baseline, in the TREMFYA and secukinumab groups:
- The mean±standard deviation (SD) PASI scores were 7.9±4.0 and 7.2±3.0, while the mean±SD TCS scores were 7.2±1.1 and 7.3±1.1, respectively.
- Eight patients (40%) in each group reported joint pain (VAS 100), with mean (SD) VAS 100 scores of 34.6±19.9 and 54.0±28.0, respectively.
- Nail PsO was present in 13 (65%) and 12 (60%) patients, scalp PsO in 13 (65%) and 12 (60%) patients, and palm PsO in 6 (30%) and 1 (5%) patient, respectively.

Efficacy

The primary endpoint of this study was not met. At week 16, the proportion of patients who responded to the treatment (TCS of 0-2 [clear/almost clear status]) were numerically higher in the secukinumab group (60.0% [95% CI, 36.1-80.9]) vs TREMFYA group (40.0% [95% CI, 19.1-63.9]).
No statistically significant difference between the 2 treatment groups were observed (20%; P=0.1715).
Both TREMFYA and secukinumab treatments resulted in a reduction of additional exploratory endpoints as described in Table: Change from Baseline in Exploratory Endpoints at Week 16.
Secukinumab had numerically greater efficacy for all exploratory endpoints except PSSI compared to TREMFYA.

Change from Baseline in Exploratory Endpoints at Week 16⁸

	TREMFYA 100 mg		Secukinumab 300 mg
	n	Mean (±SD)	n	Mean (±SD)
TCS	20	-4.05 (±3.08)	20	-4.9 (±3.35)
VAS (100)	8	7.80 (±18.80)	8	-22.30 (±26.70)
BSA	19	-4.37 (±2.93)	20	-5.54 (±7.07)
PASI	19	-3.97 (±2.36)	20	-5.09 (±3.69)
IGA	19	-0.95 (±0.91)	20	-1.70 (±1.08)
Total NAPSI	12	6.08 (±24.87)	12	-1.67 (±10.71)
Finger NAPSI	10	0.60 (±5.85)	12	-1.75 (±5.03)
PSSI	12	-13.42 (±10.10)	12	-12.33 (±6.36)
ppIGA	5	-0.80 (±0.45)	2	-1.00 (±1.41)
Abbreviations: BSA, body surface area; IGA, Investigator’s Global Assessment; NAPSI, Nail Psoriasis Severity Index; PASI, Psoriasis Area and Severity Index; ppIGA, Palmoplantar Investigator's Global Assessment; PSSI, Psoriasis Scalp Severity Index; SD, standard deviation; TCS, total clinical score; VAS, visual analog scale.

Safety

The rates of AEs were similar between the treatment groups and no patients discontinued the study due to AEs. Six patients (30%) in the TREMFYA group and 12 patients (60.0%) in the secukinumab group reported 1 AE.³^,⁸
The most frequently reported AEs were infections and infestations (TREMFYA, n=2; secukinumab, n=7) and skin and subcutaneous disorder (TREMFYA, n=3; secukinumab, n=1).⁸
Treatment-emergent AEs (TEAEs) were reported in 1 patient in the TREMFYA group and 2 in the secukinumab group. TEAEs reported were mild, with 1 serious event (hyperglycemia) reported in a secukinumab-treated patient.³^,⁸

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 19 July 2024.

Summarized in this response is relevant data from the ECLIPSE and ARROW studies.

References

Show

1	Reich K, Armstrong AW, Langley RG, et al. Guselkumab versus secukinumab for the treatment of moderate-to-severe psoriasis (ECLIPSE): results from a phase 3, randomised controlled trial. Lancet. 2019;394(10201):831-839.
2	Blauvelt A, Armstrong AW, Langley RG, et al. Efficacy of guselkumab versus secukinumab in subpopulations of patients with moderate-to-severe plaque psoriasis: results from the ECLIPSE study. J Dermatol Treat. 2022;33(4):2317-2324.
3	Krueger J, Langley R, Nigen S, et al. Secukinumab versus guselkumab in the complete resolution of ustekinumab‐resistant psoriatic plaques: The ARROW study. [published online ahead of print June 05, 2023]. Exp Dermatol. 2023. doi:10.1111/exd.14828.
4	Langley R, Blauvelt A, Armstrong A, et al. Guselkumab demonstrates superior long-term responses to secukinumab at week 48 in the treatment of moderate to severe psoriasis: results from the ECLIPSE trial. Poster presented at: 3rd Inflammatory Skin Disease Summit; December 12-15, 2018; Vienna, Austria.
5	Blauvelt A, Vender R, Spelman L, et al. Efficacy of guselkumab versus secukinumab in patients with moderate-to-severe plaque psoriasis in subgroups defined by previous psoriasis medication history: results from the ECLIPSE study. Poster presented at: 28th European Academy of Dermatology and Venereology (EADV) Congress; October 9-13, 2019; Madrid, Spain.
6	Armstrong A, Blauvelt A, Flavin S, et al. Guselkumab demonstrates greater efficacy compared to secukinumab across body weight quartiles and body mass index categories: week 48 results from the ECLIPSE trial. Poster presented at: 28th European Academy of Dermatology and Venereology (EADV) Congress; October 9-13, 2019; Madrid, Spain.
7	Reich K, Gottlieb A, Guenther L, et al. Clinical responses by self-reported PsA status at baseline among patients with moderate-to-severe psoriasis treated with guselkumab vs secukinumab: week 48 results from the ECLIPSE study. presented at: American Academy of Dermatology; June 12-14, 2020; E-Congress.
8	Krueger J, Langley R, Nigen S. Supplement to: Secukinumab versus guselkumab in the complete resolution of ustekinumab-resistant psoriatic plaques: The ARROW study. [published online ahead of print June 05, 2023]. Exp Dermatol. 2023. doi:10.1111/exd.14828.