TREMFYA - Use in Adult Patients with Psoriasis or Psoriatic Arthritis with Comorbid Crohn’s Disease or Ulcerative Colitis

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 adult patients treated with TREMFYA, including 2 patients with a prior history of IBD in DISCOVER-1 and DISCOVER-2.¹
• Case reports of adult patients with psoriasis (PsO) or active psoriatic arthritis (PsA) with comorbid Crohn’s disease (CD) or ulcerative colitis (UC) are summarized below.^2-6

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 adult patients with moderate to severe plaque PsO (VOYAGE 1 and VOYAGE 2) or 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.⁷
• 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

Tang et al (2026)⁶ described a case of a 51-year-old female with a history of PsO over 20 years, previously treated with ixekizumab, developed the new onset of UC and treated with TREMFYA.

• The patient developed abdominal pain and diarrhea that progressed to mucous-bloody stools.
• Laboratory findings showed elevated inflammatory markers, including a C-reactive protein (CRP) level of 30.87 mg/L, an erythrocyte sedimentation rate (ESR) of 50 mm/hour, and a white blood cell (WBC) count of 10.08×10⁹/L.
• Colonoscopy demonstrated loss of the mucosal vascular pattern extending from the sigmoid colon to the anus, with continuous friable mucosa exhibiting contact bleeding, a granular appearance, and patchy erosions with purulent exudate. A diagnosis of E2, S2 UC according to the Montreal classification was established.
• She was treated with mesalazine (4 g/day for 2 months). However, after inadequate response to mesalazine, infliximab (IFX; 300 mg intravenous [IV] administered for 3 treatment cycles) was initiated, resulting in improvement in CRP (0.51 mg/dL), ESR levels (16 mm/hour), and WBC count (5.47×10⁹/L); ixekizumab was discontinued during this period.
• This was followed by recurrence of psoriatic lesions, characterized by generalized erythema and scales visible throughout the body, particularly around the waist, accompanied by itching.
• TREMFYA 100 mg every 8 weeks was subsequently initiated. Four months after initiation, the patient achieved a Psoriasis Area and Severity Index (PASI) score of 0, and treatment was continued. IFX was discontinued, and mesalazine (4 g/day) was reintroduced.
• Follow-up laboratory examination showed a CRP level of 5.74 mg/L, ESR of 24 mm/hour, and WBC count of 6.71×10⁹/L. Colonoscopy revealed pale mucosa with multiple white scar-like changes and polypoid hyperplasia in the sigmoid colon, without erosions, ulcers, or luminal narrowing; vascular patterns were indistinct. The Mayo endoscopic score and UC endoscopic index of severity score were both 1.
• The patient continued treatment with TREMFYA (100 mg every 8 weeks) in combination with mesalazine (4 g/day). During followup, treatment adherence was excellent, and no drugrelated AEs were reported.

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 IFX-induced PsO.

• Prior, for the patient's UC, he was treated with mesalazine (4 g/day) for 3 months with no improvement and was switched to IFX, 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 IV 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), PsO, 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 IFX treatment, TREMFYA 100 mg was initiated at baseline and weeks 5, 12, and 20 (patient was traveling during week 4).
• For an overview of the patient’s clinical response to treatment, see Table: Summary of Clinical Response to TREMFYA.

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

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

• The patient had a history of ileocolonic resection and had been previously treated with IFX and mesalamine for CD and PsO.
• IFX treatment was not effective for PsO 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 PsO 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 PsO 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 PsO and PsA who developed CD and received treatment with TREMFYA.

• The patient was on secukinumab treatment for PsO 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 PsO and PsA.
• Treatment with TREMFYA was initiated. The patient has been on TREMFYA for over a year and has sustained a 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 24 March 2026.