Moderate to Severe Plaque Psoriasis Treatment | TREMFYA® (guselkumab) HCP

PsO

COMPLETE SKIN CLEARANCE1-3

In VOYAGE 1 and VOYAGE 2, co-primary endpoints of PASI 90 and IGA 0/1 at 16 weeks were met. A majority of patients (53%) in VOYAGE 1 achieved IGA 0 at Week 24 Click here for full details

PsO

LASTING SKIN CLEARANCE AT 5 YEARS4*

PASI 90, IGA 0, and PASI 100 response rates were maintained at 5 years* in an open-label extension study in moderate to severe plaque Ps04Click here for full details

PsA

SIGNIFICANT JOINT SYMPTOM IMPROVEMENT1,4-6

A majority of patients achieved ACR20 response at Week 24 in both DISCOVER 1 (52%) and DISCOVER 2 (64%)5,6Click here for full details

PsO

BEST-IN-CLASS ACCESS AMONG THE IL-23s†‡

Nationally, 9 out of 10 patients have preferred, first-line access for TREMFYA®Click here for full details

*Year 5 represents Week 252 for efficacy and Week 264 for safety.

Source: Managed Markets Insight and Technology, LLC, a trademark of MMIT, as of November 2021.

“Best-in-class” means the number of first-line covered lives is greater for TREMFYA® than for other products in the IL-23 inhibitor class (Skyrizi® [risankizumab-rzaa], Ilumya® [tildrakizumab-asmn]).

IN MODERATE TO SEVERE PLAQUE PsO EMERGE TREMFYANT®
WITH COMPLETE SKIN CLEARANCE IN A MAJORITY OF PATIENTS

CO-PRIMARY ENDPOINTS: PASI 90*AND IGA 0/1* AT WEEK 16

  • VOYAGE 1: 73% (241/329) of patients receiving TREMFYA® achieved PASI 90 compared with 3% (5/174) of patients receiving placebo (P<0.001). 85% (280/329) of patients receiving TREMFYA® achieved IGA 0/1 compared with 7% (12/174) of patients receiving placebo (P<0.001)1,2†§
  • VOYAGE 2: 70% (347/496) of patients receiving TREMFYA® achieved PASI 90 compared with 2% (6/248) of patients receiving placebo (P<0.001). 84% (417/496) of patients receiving TREMFYA® achieved IGA 0/1 compared with 8% (21/248) of patients receiving placebo (P<0.001)1,3†§

IN VOYAGE 1 AT WEEK 48 (MAJOR SECONDARY ENDPOINT, NORTH AMERICAN ANALYSIS)

  • 47% (54/115) of patients receiving TREMFYA® achieved IGA 0* compared with 24% (28/115) of patients receiving an active comparator (P<0.001)1,2,4†‡

IN VOYAGE 2 AT WEEK 24 (MAJOR SECONDARY ENDPOINT, NORTH AMERICAN ANALYSIS)

  • 48% (76/160) of patients receiving TREMFYA® achieved IGA 0* compared with 28% (23/81) of patients receiving an active comparator (P=0.005)1,4†||

IGA=Investigator’s Global Assessment; PASI=Psoriasis Area and Severity Index.

*PASI 90=proportion of patients who achieved 90% or more reduction (or improvement) in PASI; IGA 0/1=proportion of patients who achieved IGA score of cleared (0) or minimal (1) using a 5-point scale where psoriatic lesions are graded by the investigator for induration, erythema, and scaling on a scale of 0 to 4: cleared, except for residual discoloration (0), minimal (1), mild (2), moderate (3), or severe (4); IGA 0=proportion of patients who achieved an IGA score of cleared (0).

Nonresponder imputation (NRI) methods were used for analysis.

Based on the results of an analysis of 38 North American sites (United States=27, Canada=11) from VOYAGE 1.

§Based on the results of an analysis of 101 global sites from VOYAGE 1 and 115 global sites from VOYAGE 2 (including North American sites [ie, United States and Canada]).

IIBased on the results of an analysis of 41 North American sites (United States=31, Canada=10) from VOYAGE 2 that used a US-licensed active comparator.


TREMFYA® DEMONSTRATED LASTING SKIN CLEARANCE AT 5 YEARS* IN AN OPEN-LABEL EXTENSION STUDY IN MODERATE TO SEVERE PLAQUE PsO

Skin Clearance Rates Maintained at 5 Years4*

VOYAGE 1: PRESPECIFIED SECONDARY ANALYSIS RESULTS THROUGH YEAR 5 (AS-OBSERVED, GLOBAL ANALYSIS)4†‡§||

IN A PRESPECIFIED SECONDARY ANALYSIS OF EFFICACY AFTER WEEK 48 APPLYING TREATMENT FAILURE RULES (TFR)4†‡§II#:

  • PASI 90: 80% (373/468) at Year 1; 82% (368/448) at Week 100; 83% (358/432) at Year 3; 82% (338/411) at Week 204; 84% (329/391) at Week 252
  • IGA 0: 54% (251/468) at Year 1; 56% (249/448) at Week 100; 53% (229/430) at Year 3; 57% (234/410) at Week 204; 55% (214/391) at Week 252
  • PASI 100: 49% (230/468) at Year 1; 51% (229/448) at Week 100; 51% (220/432) at Year 3; 56% (229/441) at Week 204; 53% (206/391) at Week 252

Patients who lose response or are unable to tolerate treatment are likely to discontinue treatment, which may increase the response rate in an as-observed analysis.

*Year 5 represents Week 252.

The same patients may not have responded at each time point.

Data shown include patients randomized at Week 0 to the TREMFYA® arm and placebo-arm patients who crossed over to receive TREMFYA® at Weeks 16 and 20 and q8w thereafter.

§Available data at each visit were used; missing data were not included in the analysis.

IIBased on the results of an analysis of 101 global sites from VOYAGE 1 (including North American sites [ie, United States and Canada]).

First selective IL-23 inhibitor phase 3 efficacy and safety data from a 5-year open-label extension in moderate to severe plaque PsO presented at a scientific congress.

#TFR methods: Patients who discontinued study agent due to lack of efficacy or an adverse event of worsening of psoriasis, or who started a protocol-prohibited medication, including conventional and biologic systemic therapy, phototherapy, and/or ultra–high-potency corticosteroids, were considered treatment failures. Other topical agents for psoriasis were permitted.


IN ADULTS WITH ACTIVE PsA EMERGE TREMFYANT®
WITH SIGNIFICANT JOINT RESPONSE (ACR20 AT WEEK 24)

IN DISCOVER 1: ACR RESPONSES AT WEEK 24 (NRI)1,4,6*:

  • ACR20 response (primary endpoint): 52% (66/127) of patients receiving TREMFYA® q8w achieved an ACR20 response compared with 22% (28/126) of patients receiving placebo (P<0.0001); ACR50 response (major secondary endpoint): 30% (38/127) of patients receiving TREMFYA® q8w achieved an ACR50 response compared with 9% (11/126) of patients receiving placebo (P<0.0001); ACR70 response (major secondary endpoint): 12% (15/127) of patients receiving TREMFYA® q8w achieved an ACR70 response compared with 6% (7/126) of patients receiving placebo (P=0.069)

IN DISCOVER 2: ACR RESPONSES AT WEEK 24 (NRI)1,4,5*:

  • ACR50 response (major secondary endpoint): 32% (78/248) of patients receiving TREMFYA® q8w achieved an ACR50 response compared with 14% (35/246) of patients receiving placebo (P<0.0001); ACR70 response (major secondary endpoint): 19% (46/248) of patients receiving TREMFYA® q8w achieved an ACR70 response compared with 4% (10/246) of patients receiving placebo (P<0.0001)

ACR50 response and ACR70 response at Week 24 from DISCOVER 1 and DISCOVER 2 were not part of the sequential testing procedure but were prespecified to be tested upon achieving statistical significance for ACR20 at Week 24.

*Through Week 24, patients were considered to be nonresponders after meeting treatment failure criteria: discontinued study agent for any reason, terminated study participation for any reason, initiated or increased the dose of DMARDs or oral corticosteroids over baseline for PsA, or initiated protocol-prohibited medications/therapies for PsA. After Week 24, treatment failure rules were not applied.

Patients with missing data were considered nonresponders.


The information provided does not imply comparable safety or efficacy between products and only represents access information. Indicated trademarks are the registered trademarks of their respective owners. Please refer to each product’s prescribing information for indication(s), recommended dosing, and administration.

IL=interleukin.

*“Preferred” means TREMFYA® can be accessed first-line (ie, step therapy is not required) and its formulary status is better than or equivalent to other products in the class.

“Best-in-class” means the number of first-line covered lives is greater for TREMFYA® than for other products in the IL-23 inhibitor class (Skyrizi® [risankizumab-rzaa], Ilumya® [tildrakizumab-asmn]).

“Superior” means the number of first-line covered lives is at least 10% greater for TREMFYA® than for products in the IL-17 inhibitor class (Cosentyx® [secukinumab], Taltz® [ixekizumab], Siliq® [brodalumab]).

Collected in November 2021 and is subject to change. This information does not provide advice or guarantee coverage or payment.

Legal requirements and plan information can be updated frequently. We strongly recommend contacting the plan for more information about current coverage, restrictions, or prerequisites that may apply.

This may not represent 100% of formulary lives due to data limitations.

Source: Managed Markets Insight and Technology, LLC™, a trademark of MMIT, as of November 2021.

 

IN ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS UNCOVER TREMFYA®

Teaser: 

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