Summary

• The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
• Please refer to the local labeling and guidelines and/or protocols for relevant information regarding tuberculosis (TB) screening in patients initiating treatment with TREMFYA.  
• Information on TB screening in patients initiating treatment with TREMFYA for moderate to severe plaque psoriasis (PsO) or active psoriatic arthritis (PsA) from the pivotal clinical trials, VOYAGE 1, VOYAGE 2, DISCOVER-1 and DISCOVER-2, is summarized below.^1-3

Company core data sheet

Pre-treatment evaluation for tuberculosis

In clinical studies, subjects with latent TB who were concurrently treated with TREMFYA and appropriate TB prophylaxis did not develop TB. Evaluate patients for TB infection prior to initiating treatment with TREMFYA. Initiate treatment of latent TB prior to administering TREMFYA. Patients receiving TREMFYA should be monitored for signs and symptoms of active TB during and after treatment. Do not administer TREMFYA to patients with active TB infection. Consider anti-TB therapy prior to initiating TREMFYA in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.⁴

CLINICAL DATA in moderate to severe plaque psoriasis

VOYAGE 1 and VOYAGE 2

Blauvelt et al (2017)⁵ and Reich et al (2017)⁶ summarized two phase 3, randomized, double-blind, placebo- and adalimumab comparator-controlled studies designed to evaluate the safety and efficacy of TREMFYA in patients with moderate to severe plaque PsO.  

VOYAGE 1 and VOYAGE 2 were conducted in adult patients with moderate to severe plaque PsO (defined as Investigator’s Global Assessment [IGA] score ≥3, a Psoriasis Area and Severity Index [PASI] score ≥12, and body surface area [BSA] involvement ≥10%) for ≥6 months and who were candidates for phototherapy or systemic therapy.^5,6

Study Design/Methods

• In the VOYAGE 1 and VOYAGE 2 studies, patients were screened for latent tuberculosis infection (LTBI) prior to being randomized to TREMFYA 100 mg every 8 weeks (q8w), adalimumab every 2 weeks (q2w), or placebo.¹
• Eligible patients had no history of LTBI or active TB.
  • Patients with LTBI based on positive TB test during screening (QuantiFERON^®-TB Gold or Purified Protein Derivative testing) were eligible if active TB was ruled out and appropriate LTBI treatment was initiated prior to or simultaneously with the first study agent administration, or if appropriate LTBI treatment was completed within 5 years prior to first administration.

CLINICAL DATA in active Psoriatic arthritis

DISCOVER-1 and discover-2

Deodhar et al (2020)⁷ and Mease et al (2020)⁸ summarized two phase 3, randomized, double-blind, multicenter, placebo-controlled studies designed to evaluate the safety and efficacy of TREMFYA in patients with active PsA.  

DISCOVER-1 was conducted in adult patients with active PsA who were biologic-naïve or had a prior biologic experience of ≤2 anti-tumor necrosis factor alpha (anti-TNFα) treatments and had inadequate response to or intolerance of standard therapies, including nonbiologic disease modifying antirheumatic drugs (DMARDs), apremilast, and nonsteroidal anti-inflammatory drug (NSAIDs).⁷

DISCOVER-2 was conducted in adult patients with active PsA who were biologic-naïve and had inadequate response to or intolerance of standard therapies, including nonbiologic DMARDs, apremilast, and NSAIDs.⁸

Study Design/Methods

• In DISCOVER-1 and DISCOVER-2, patients were screened for TB prior to being randomized to TREMFYA 100 mg q8w, TREMFYA 100 mg every 4 weeks (q4w), or placebo.^7,8
• Patients were considered eligible according to the following TB screening criteria^2,3:
  • No history of LTBI or active TB prior to screening. Patients with LTBI based on a positive TB test during screening (QuantiFERON^®-TB Gold or tuberculin skin test conducted within 8 weeks prior to the first administration of study agent) were eligible if active TB was ruled out and appropriate LTBI treatment was initiated prior to the first administration of study agent or if appropriate LTBI treatment was completed within 5 years prior to the first administration.
    • Patients with persistently indeterminate QuantiFERON^®-TB Gold test results were enrolled without treatment for LTBI if active TB was ruled out, chest radiograph showed no abnormality suggestive of TB (active or old, inactive TB), and no additional risk factors for TB, as determined by the investigator.
  • No signs or symptoms suggestive of active TB upon medical history and/or physical examination.
  • No recent close contact with a person with active TB or, if there had been such contact, were referred to a physician specializing in TB to undergo additional evaluation and, if warranted, received appropriate treatment for LTBI prior to the first administration of study agent.
  • Chest radiograph (posterior-anterior view) obtained within 3 months prior to the first administration of study agent, with no evidence of current, active TB or old, inactive TB.

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 09 April 2024.