SUMMARY

• The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
• The phase 3 clinical trial program of TREMFYA in the treatment of adults with moderately to severely active Crohn's disease through week 48 did not evaluate dose escalation (eg, higher doses or more frequent dosing) during maintenance therapy with 200 mg subcutaneous (SC) injection every 4 weeks (q4w) or 100 mg SC injection every 8 weeks (q8w).¹
• Participants who benefit from continued treatment, in the opinion of the investigator, are eligible to enter the long-term extension (LTE) and receive approximately 4 additional years of treatment.¹
• During the LTE, patients who met criteria for loss of clinical response between weeks 52 (the first visit at which treatment adjustment is permitted) and 80 (the last visit at which treatment adjustment is permitted) are eligible to receive a single-blinded dose adjustment as described below:
  • TREMFYA 100 mg SC q8w group: adjust to receive TREMFYA 200 mg SC q4w.¹
  • TREMFYA 200 mg SC q4w group: continue TREMFYA 200 mg SC q4w (eg, sham dose adjustment).¹
  • Placebo SC randomized group: adjust to receive TREMFYA 200 mg SC q4w.¹
  • STELARA 90 mg SC q8w group: switched to receive TREMFYA 200 mg SC q4w.¹
• Loss of clinical response was defined as not achieving clinical response and having a Crohn’s Disease Activity Index (CDAI) score of at least 220 points. Clinical response was defined as a reduction from baseline in the CDAI score of ≥100 points or CDAI score<150 points.¹
• Participants who receive a dose adjustment in the LTE will be re-evaluated at week 96. Continued participation in the LTE will be decided per the investigator's clinical judgement through clinical and endoscopic evaluations at week 96, 144, and 192.¹

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 24 June 2024.