Logo

Adverse events reporting | Prescribing information ( This product is under additional monitoring)

TREMFYA®: lasting, consistent relief[1]

line

Demonstrable joint efficacy

Bio-naïve
Bio-experienced
Anti-TNF refractory

TREMFYA® in bio-naïve PsA patients - results from the DISCOVER-2 study

Sustained joint symptom relief proven for 2 years in PsA[1]
  • More than 6 out of 10 bio-naïve PsA patients achieved ACR20 response at Week 24*[2] in the DISCOVER-2 study
ACR20 response chart
Patients achieving ACR20 responses with TREMFYA® through to Week 100 (NRI)[1][2][3]

Adapted from McInnes IB, et al. 2021,[1] Mease PJ, et al 2020,[2] and McInnes IB, et al. 2021.[3]

Primary endpoint at Week 24. FAS applied at Week 24, NRI applied thereafter. n number corresponds to the total sample of patients analysed for specific measure at timepoint. ACR20, American College of Rheumatology 20% improvement; FAS, Full Analysis Set; NRI, non-responder imputation; PsA, psoriatic arthritis; q4w, every 4 weeks; q8w, every 8 weeks. Absolute differences at Week 24: TREMFYA® q8w vs. placebo – 31%, p<0.0001; TREMFYA® q4w vs. placebo – 31%, p<0.0001. Adjusted p-value.[2]

  • ACR20 response rates at 1 year maintained at 2 years and numerically increased for ACR50 and ACR70[1][3] in the DISCOVER-2 study
ACR50 response chart
Patients achieving ACR50 responses with TREMFYA® through to Week 100 (NRI)[1][2][3]

Adapted from McInnes IB, et al. 2021,[1] McInnes IB, et al. 2020,[2] and Mease PJ, et al. 2020.[3]

n number corresponds to the total sample of patients analysed for specific measure at timepoint. ACR50, American College of Rheumatology 50% improvement; NRI, non-responder imputation; PsA, psoriatic arthritis; q4w, every 4 weeks; q8w, every 8 weeks. Absolute differences at Week 24: TREMFYA® q4w vs. placebo – 18%, p=0.0056. Adjusted p-value. q8w not formally tested for significance based on the hierarchical testing procedure in the statistical analysis plan.

TREMFYA® limits structural damage progression over time[1]
  • TREMFYA® limited structural damage progression, with radiographic progression rates gradually declining over 2 years of treatment[1]

For PsA patients at high risk for joint damage according to clinical judgement, a dose of 100 mg every 4 weeks may be considered[4]

Radiographic progression chart
Mean change in structural damage progression (vdH-S) from Week 0 to 100 (NRI)[1][2][3]

Adapted from McInnes IB, et al. 2021[1] and McInnes IB, et al. 2021[3]

Change from Week 24-52 after transition from placebo. The smallest detectable change in the total PsA-modified SHS was 1.85 for Weeks 0–24, 1.91 for Weeks 24–52, and 2.39 for Weeks 0–52. PsA, psoriatic arthritis; vdH-S, Sharp-van der Hejde score

Improvements in ACR score mean less pain and swelling[5] and limiting structural damage progression improves quality of life[6]

line

Resolution of enthesitis (LEI) and dactylitis (DSS) through Week 100[1]

  • Up to 7 out of 10 PsA patients achieved resolution of enthesitis at Week 100[1] in the DISCOVER-2 study
Enthesitis Resolution chart
Resolution of enthesitis at Week 24, 52 and 100 (NRI)[1][2][3]

Adapted from McInnes IB, et al. 2021[1] McInnes IB, et al. 2020[3] and TREMFYA® SmPC.[4]

*Nominal p-value. Among patients with enthesitis or dactylitis at Week 0. Resolution of enthesitis (Leeds Enthesitis Index score=0; range 0-6) determined among patients with enthesitis at baseline. Resolution of enthesitis was pre-specified to be pooled across studies as a controlled endpoint at Week 24; pooled results are also reported at Week 52 (NRI population); 243 crossed over to TREMFYA® q4w at Week 24 and 12 received placebo only before study agent discontinuation. NRI, non-responder imputation; q4w, every 4 weeks; q8w, every 8 weeks.

  • Up to 8 out of 10 PsA patients achieved resolution of dactylitis at Week 100[1] in the DISCOVER-2 study
Dactylitis Resolution chart
Resolution of dactylitis at Week 24, 52 and 100 (NRI)[1][2][3]

Adapted from McInnes IB, et al. 2021[1] McInnes IB, et al. 2020[2] and TREMFYA® SmPC.[4]

Nominal p-value. Among patients with enthesitis or dactylitis at Week 0. Resolution of dactylitis (Dactylitis Severity Score=0; range 0-60) determined among patients with dactylitis at baseline. Resolution of dactylitis was pre-specified to be pooled across studies as a controlled endpoint at Week 24; pooled results are also reported at Week 52 (NRI population); 142 crossed over from placebo to TREMFYA® q4w at Week 24 and 12 received placebo only before study agent discontinuation. NRI, non-responder imputation; q4w, every 4 weeks; q8w, every 8 weeks.

line

Complete skin clearance

Fast[2][7] and sustained complete clearance proven for 2 years in psoriatic arthritis[1]

  • 45% of TREMFYA® PsA patients achieved PASI 100 by Week 24[2]
  • The majority of TREMFYA® PsA patients were completely or almost completely clear at 1 year§[3]
  • The majority of PsA patients achieved complete or almost complete skin clearance at 2 years[1]
Complete skin clearance graph
Patients achieving PASI 100 responses with TREMFYA® at Week 24, 52 and at Week 100 (NRI)[1][2][3]

Adapted from Mease PJ, et al. 2020,[2] McInnes IB, et al. 2021[1] and McInnes IB, et al. 2021.[3]

Secondary endpoint not controlled for multiplicity. Nominal p-value to be interpreted as supportive. n number corresponds to the total sample of patients analysed for specific measure at timepoint. Results at Week 52 have been rounded to the nearest whole number. PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis; q4w, every 4 weeks; q8w, every 8 weeks; SC, subcutaneous.

line

Proven durability*

Most patients who started on TREMFYA®, stayed on TREMFYA® long-term[1][3][8]

Discontinuations graphic
Patient retention
Adverse event profile chart
Incidences of AEs and SAEs were comparable to placebo through Week 24[2] and consistent up to Week 112[1]

Adapted from McInnes IB, et al. 2021,[1]

  • TREMFYA® was generally well tolerated in psoriatic arthritis patients in the DISCOVER studies up to Week 100[1]
Through to Week 112 in TREMFYA®-treated patients:[1]
No IBD
No tuberculosis or anaphylactic reactions
No deaths
Opportunistic infections were observed in 3 out of 731 patients (0.4%)[1]
The rates of AEs, SAEs, AEs leading to discontinuations, infections, serious infections, and injection site reactions were generally consistent with those observed at Week 24 and at Week 52[1]

Learn more about how TREMFYA® could help your patients with psoriatic arthritis

line
What does Discover-2 mean for bio-naïve patients patients with PsA?

Prescribing information is available to all viewers of this video. Please click the prescribing information tab on this page or visit https://www.medicines.ie/

What does Cosmos mean for PsA patients who have failed on anti-tnf therapy?

Prescribing information is available to all viewers of this video. Please click the prescribing information tab on this page or visit https://www.medicines.ie/

MyTremfya

MyTremfya is a support website for your patients who have been prescribed Tremfya for Psoriatic arthritis. MyTremfya provides important information to support and guide your patients on their treatment journey.

Access to patient resources for psoriatic arthritis

Specially designed resources and tools for your patients to understand their disease and treatment.

Adverse events should be reported. This medicinal product is subject to additional monitoring and it is therefore important to report any suspected adverse events related to this medicinal product. Healthcare professionals are asked to report any suspected adverse events via: HPRA Pharmacovigilance Website: www.hpra.ie. Adverse events should also be reported to Janssen Sciences Ireland UC on 1800 709 122 or at dsafety@its.jnj.com.

Durability*, also known as patient retention or drug survival is a combination of efficacy, safety, tolerability and patient satisfaction or preference.

*64% of TREMFYA® q8w patients achieved ACR20 at Week 24 in DISCOVER-2.[2]
DISCOVER-2: in patients treated with TREMFYA® q8w. 74.6% of TREMFYA® q8w patients achieved ACR20 at 1 year, and 74% of TREMFYA® q8w patients achieved ACR20 at 2 years (non-responder imputation). In patients treated with TREMFYA® q8w. 48.4% of TREMFYA® q8w patients achieved ACR50 at 1 year, and 55% of TREMFYA® q8w patients achieved ACR50 at 2 years (non-responder imputation). 27.8% of TREMFYA® q8w patients achieved ACR70 at 1 year, and 36% of TREMFYA® q8w patients achieved ACR70 at 2 years (non-responder imputation).[1][3]
45% of PsA patients treated with TREMFYA® achieved PASI 100 at Week 24 (n=176).[2]
§In DISCOVER-2. Patients randomised to TREMFYA® q8w at baseline. Patients achieving PASI 90 at Week 52: 74.4% (NRI). Patients achieving PASI 100 at Week 52: 52.8% (NRI).[3]
DISCOVER-2: in patients randomised to TREMFYA® at baseline and treated with TREMFYA® q8w. Patients achieving PASI 90 at Week 100 (non-responder imputation): 74%. Patients achieving PASI 100 at Week 100 (non-responder imputation): 53%.[1]
&Includes patients randomised to TREMFYA® at baseline, and patients who crossed over from placebo at Week 24 (PsA) and Week 16 (Pso). 88% of patients completed TREMFYA® through Week 100 in DISCOVER-2.[1] 76.9% of patients completed TREMFYA® through Week 252 in VOYAGE 1.[9]
**When prescribing TREMFYA® q4w in psoriatic arthritis, it is recommended to evaluate liver enzymes at baseline and thereafter according to routine patient management. Very common adverse events of TREMFYA® were respiratory tract infections. Common adverse events of TREMFYA® transaminases increased, headache, diarrhoea, arthralgia and injection site reactions.[4]
††One death observed in the placebo to TREMFYA® q4w group, not related to the medication (road traffic accident).[1]

References

McInnes IB, et al. Efficacy and Safety of Guselkumab, a Monoclonal Antibody Specific to the p19-Subunit of Interleukin-23, Through 2 Years: Results from a Phase 3, Randomized, Double-blind, Placebo-controlled Study Conducted in Biologic-naïve Patients with Active Psoriatic Arthritis. Presented at Innovations in Dermatology Conference, March 16-20, 2021. Online.
Mease PJ, et al. Lancet 2020;395:1126-1136.
McInnes IB, et al. Arthritis Rheumatol. 2021;73:604-616.
Felson DT, LaValley MP. Arthritis Res Ther 2014;16:101.
van der Heijde D, et al. Arthritis Res Ther 20203;22:18.
Blauvelt A et al. J Am Acad Dermatol 2017;76(3):405–417
Ritchlin CT, et al. RMD Open. 2021;7:e001457.
Griffiths CEM, et al. Maintenance of Response Through 5 Years of Continuous Guselkumab Treatment: Results From the Phase 3 VOYAGE 1 Trial. Presented at the 16th Annual Coastal Dermatology Symposium. October 15-16, 2020.
Deodhar A et al. Lancet 2020
Laura C Coates et al. Ann Rheum Dis: first published as 10.1136/annrheumdis-2021-220991 on 24 November 2021. Efficacy and safety of guselkumab in patients with active psoriatic arthritis who are inadequate responders to tumour necrosis factor inhibitors: results through one year of a phase IIIb, randomised, controlled study (COSMOS).
CP-243578 - February 2022