Summary

• The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
• In a pooled analysis of the VOYAGE 1, VOYAGE 2, DISCOVER-1, and DISCOVER-2 studies, there were no reports of exacerbation or new onset of inflammatory bowel disease (IBD) in patients treated with TREMFYA, including 2 patients with a prior history of IBD in DISCOVER-1 and DISCOVER-2.¹
• Case reports of patients with psoriasis or psoriatic arthritis (PsA) with comorbid Crohn’s disease (CD) or ulcerative colitis (UC) are summarized below.^2-5

CLINICAL DATA

Pooled Analysis of Phase 3 Studies

Mease et al (2021)¹ evaluated the incidence of adverse events (AEs), including serious AEs (SAEs) and gastrointestinal-related SAEs, with TREMFYA using pooled safety data of patients with moderate to severe plaque psoriasis (VOYAGE 1 and VOYAGE 2) and active PsA (DISCOVER-1 and DISCOVER-2) through 1 year of treatment.

• Patients randomized to the placebo group at baseline who crossed over to receive TREMFYA at week 24 (DISCOVER-1 and DISCOVER-2) or week 16 (VOYAGE 1 and VOYAGE 2) or those who switched treatment inadvertently were included in the analysis.⁶
• Data were analyzed through week 60 for DISCOVER-1, week 52 for DISCOVER-2, and week 48 for both VOYAGE 1 and VOYAGE 2.
• Patients with a previous history of IBD were not excluded; IBD history was collected at baseline in DISCOVER-1 and DISCOVER-2.
• Overall, no cases of exacerbation or new onset of IBD were reported in TREMFYA-treated patients, including 2 patients with a prior history of IBD in DISCOVER-1 and DISCOVER-2.

Case Reports

Dai and Huang (2024)² described the case of a 38-year-old male patient with a 14-year history of UC who was treated with TREMFYA for infliximab-induced psoriasis.

• Prior, for the patient's UC, he was treated with mesalazine (4 g/day) for 3 months with no improvement and was switched to infliximab, which controlled gastrointestinal symptoms, normalized laboratory parameters, and led to mucosal healing.
• After 36 months, the patient developed rashes on palms, soles, and scalp that did not respond to over-the-counter topical corticosteroids.
• Ustekinumab was initiated at an induction dose of 260 mg intravenously followed by a maintenance dose of 90 mg subcutaneously every 8 weeks. After 5 treatments with ustekinumab, his skin disease worsened.
• Subsequently, the patient was switched to TREMFYA 100 mg every 4 weeks, which resulted in complete resolution of psoriatic plaques after 4 treatments.
• Eight months later, the patient’s UC remained asymptomatic with complete mucosal healing.

Berman et al (2021)³ described the case of a 28-year-old female patient with hidradenitis suppurativa (HS), psoriasis, and CD who received treatment with TREMFYA.

• The patient was reported to have failed multiple treatments including antibiotics, phototherapy, and biologic agents.
• Two weeks after the discontinuation of infliximab treatment, TREMFYA 100 mg was initiated at baseline and weeks 5, 12, and 20.
• For an overview of the patient’s clinical response to treatment, see Table: Clinical Response to TREMFYA.

• At week 28, it was reported that the patient’s psoriasis, HS, and CD were in remission.

Grossberg (2019)⁴ described the case of a 66-year-old female patient with psoriasis and ileocolonic CD who received treatment with TREMFYA.

• The patient had a history of ileocolonic resection and had been previously treated with infliximab and mesalamine for CD and psoriasis.
• Infliximab treatment was not effective for psoriasis and the patient was switched to ixekizumab. However, the patient developed diarrhea after several months.
  • Colonoscopy results showed an ulcerated, severe stenosis in the proximal descending colon and diffuse patchy erythema in the sigmoid and descending colon. Biopsies showed chronic active colitis.
• Ustekinumab was initiated at a dose for psoriasis and after 6 months of treatment, colonoscopy revealed normal colonic mucosa, but there was narrowing and ulceration at the ileocolonic anastomosis and ulceration in the neoterminal ileum.
• The patient’s psoriasis was not controlled with ustekinumab treatment, and therefore, the patient was switched to TREMFYA and methotrexate 15 mg weekly.
  • A colonoscopy performed several months later demonstrated deep remission with normal colon, anastomosis, and neoterminal ileum.

Shaw et al (2019)⁵ described the case of a 56-year-old male patient with plaque psoriasis and PsA who developed CD and received treatment with TREMFYA.

• The patient was on secukinumab treatment for psoriasis and PsA but was switched to ustekinumab after a routine colonoscopy and subsequent biopsy revealed findings of CD. The patient continued to experience flares of psoriasis and PsA.
• Treatment with TREMFYA was initiated. The patient has been on TREMFYA for over a year and has sustained a Psoriasis Area and Severity Index (PASI) of 0, and CD remained asymptomatic.

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 17 June 2024.