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TREMFYA® (guselkumab)
Medical Information
TREMFYA - Effect on Extraintestinal Manifestations in Adult Patients with Crohn’s Disease or Ulcerative Colitis
Last Updated: 03/10/2026
SUMMARY
- The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
- The GALAXI 2 & 3 clinical trials reported the effects of TREMFYA on extraintestinal manifestations (EIMs) in patients with moderately to severely active Crohn's disease (CD).1
- A case report describing the use of TREMFYA in patients with CD and EIMs is summarized below.2
- There are no published data for the use of TREMFYA for EIMs in patients with ulcerative colitis (UC).
CLINICAL DATA
GALAXI 2 & 3 Studies
GALAXI 2 & 3 are 2 identical 48-week, phase 3, randomized, double-blind, triple-dummy, placebo (PBO)- and active-controlled, treat through studies evaluating the efficacy and safety of TREMFYA in adults with moderately to severely active CD who had an inadequate response or intolerance to conventional (corticosteroids, azathioprine, 6-mercaptopurine, methotrexate), and/or biologic therapies (tumor necrosis factor antagonists or vedolizumab). See Figure: GALAXI 2&3 Study Design.
Abbreviations: AP, abdominal pain; BIO, biologic; CD, Crohn’s disease; CDAI, Crohn’s disease Activity Index; CS, corticosteroid; GUS, Guselkumab; IV, intravenous; NRes, nonresponder; PBO, placebo; q4w, every 4 weeks; q8w, every 8 weeks; R, randomization; Res, responder; SC, subcutaneous; SES-CD, Simple Endoscopic Score for Crohn’s Disease; SF, Stool frequency; UST, ustekinumab.
Effect on Extraintestinal Manifestations
- EIMs, individual EIM resolution, and de novo EIMs were reported as a component of the Crohn's disease activity index (CDAI) at each visit at weeks 12 and 48. EIM was pooled for GALAXI 2&3.1
- A total of 201/582 (34.5%) patients treated with TREMFYA and 63/148 (42.6%) patients treated with PBO had EIMs at baseline.
- For baseline characteristics of patients with EIMs, see Table: Pooled GALAXI 2&3 Baseline Characteristics of Patients with EIMs.
| TREMFYA 200 mg IV q4w→100 mg SC q8w (N=286) | TREMFYA 200 mg IV q4w→200 mg SC q4w (N=296) | TREMFYA Combined (N=582) | PBO (N=148) | |
|---|---|---|---|---|
| Number of patients with EIMs, n (%) | 115 (40.2) | 86 (29.1) | 201 (34.5) | 63 (42.6) |
| Age, years, mean (SD) | 37.2 (12.11) | 39.1 (13.81) | 38.0 (12.86) | 37.7 (13.16) |
| CD duration in years, mean (SD) | 7.4 (7.01) | 7.9 (8.23) | 7.6 (7.54) | 6.9 (7.34) |
| CDAI score at baseline, mean (SD) | 302.8 (55.24) | 302.1 (51.77) | 302.5 (53.65) | 291.6 (52.46) |
| GI areas involved, n (%) | ||||
| Ileum only | 30 (26.1) | 32 (37.2) | 62 (30.8) | 17 (27.0) |
| Colon only | 40 (34.8) | 26 (30.2) | 66 (32.8) | 23 (36.5) |
| Ileum and colon | 45 (39.1) | 28 (32.6) | 73 (36.3) | 23 (36.5) |
| EIMsa | 125 | |||
| Arthritis/arthralgia | 102 (88.7) | 77 (89.5) | 179 (89.1) | 57 (90.5) |
| Erythema nodosum/ Pyoderma gangrenosum | 23 (20.0) | 14 (16.3) | 37 (18.4) | 16 (25.4) |
| Iritis, uveitis | 5 (4.3) | 6 (7.0) | 11 (5.5) | 2 (3.2) |
| Corticosteroid use, n (%) | ||||
| Oral corticosteroids | 37 (32.2) | 23 (26.7) | 60 (29.9) | 16 (25.4) |
| Budesonide | 17 (14.8) | 13 (15.1) | 30 (14.9) | 12 (20.6) |
| Prior use of TNF antagonists, n (%) | ||||
| Adalimumab | 45 (39.1) | 29 (33.7) | 74 (36.8) | 19 (30.2) |
| Certolizumab pegol | 4 (3.5) | 3 (3.5) | 7 (3.5) | 1 (1.6) |
| Infliximab | 37 (32.2) | 27 (31.4) | 64 (31.8) | 22 (34.9) |
| Vedolizumab | 13 (11.3) | 6 (7.0) | 19 (9.5) | 6 (9.5) |
| Abbreviations: CD, Crohn’s disease; CDAI, Crohn’s Disease Activity Index; EIM, extraintestinal manifestation; GI, gastrointestinal; IV, intravenous; PBO, placebo; PG, pyoderma gangrenosum; q4w, every 4 weeks; q8w, every 8 weeks; SC, subcutaneous; SD, standard deviation; TNF, tumor necrosis factor. aA single patient may have had more than 1 EIM. | ||||
EIM Resolution at Weeks 12 and 48
- At week 12 after induction, greater proportions of patients treated with TREMFYA vs those treated with PBO had resolution of overall EIMs, arthritis/arthralgia, and erythema nodosum/pyoderma gangrenosum. For individual EIM resolutions at weeks 12 and 48, see Table: EIM Outcomes at Week 12 After Induction and Table: EIM Outcomes at Week 48 After Maintenance.
- De novo EIMs were reported in 2.6% of TREMFYA-treated patients and 8.1% of PBO-treated patients.
- Greater improvements (from baseline through week 12; LS [mean]) in weighted EIM CDAI component score were observed with TREMFYA vs PBO: -5.4 (0.43) vs -0.70 (0.83), respectively. Improvements for TREMFYA 100 mg SC q8w and TREMFYA 200 mg SC q4w at week 48 were -5.5 (0.57) and -6.1 (0.057), respectively.
- Rates of uveitis/iritis were low and were not evaluated due to small sample size.
| EIM | TREMFYA 200 mg IV q4w Combined (n=582) | PBO (n=148) | ||
|---|---|---|---|---|
| Baseline | Week 12 | Baseline | Week 12 | |
| All EIMs, %(n/N) | 34.5 (201/582) | 17.0 (99/582) | 42.6 (63/148) | 45.4 (51/148) |
| Arthritis/arthralgia, %(n/N) | 30.8 (179/582) | 15.6 (91/582) | 38.5 (57/148) | 31.8 (47/148) |
| Erythema nodosum/ Pyoderma gangrenosum, %(n/N) | 6.4 (37/582) | 1.9 (11/582) | 10.8 (16/148) | 7.4 (11/148) |
| Abbreviations: EIM, extraintestinal manifestation; IV, intravenous; PBO, placebo; q4w, every 4 weeks. Note: P-values at week 12 vs baseline were nominal. Therefore, statistical significance has not been established. | ||||
| EIM | TREMFYA 200 mg IV q4w→100 mg SC q8w (n=286) | TREMFYA 200 mg IV q4w→200 mg SC q4w (n=296) | TREMFYA Combined (n=582) | |||
|---|---|---|---|---|---|---|
| Baseline | Week 48 | Baseline | Week 48 | Baseline | Week 48 | |
| Arthritis/arthralgia, %(n/N) | 35.7 (102/286) | 12.6 (36/286) | 26.0 (77/296) | 10.1 (30/296) | 30.8 (179/582) | 11.3 (66/582) |
| Erythema nodosum/ Pyoderma gangrenosum, %(n/N) | 8.0 (23/286) | 1.0 (3/286) | 4.7 (14/296) | 0.0 | 6.4 (37/582) | 0.5 (3/582) |
| Abbreviations: EIM, extraintestinal manifestation; IV, intravenous; q4w, every 4 weeks; q8w, every 8 weeks; SC, subcutaneous. Note: P-values at week 48 vs baseline were nominal. Therefore, statistical significance has not been established. | ||||||
Case report
Nikzad et al (2025)2 reported the use of TREMFYA in a 64-year-old woman with perianal fistulizing CD with concomitant cutaneous CD and pyoderma gangrenosum (PG).
- The patient presented with a 2-month history of wounds in the groin, gluteal cleft, and peristomal skin.
- Initially, the patient was treated with several anti-TNFs and then was switched to vedolizumab, and upadacitinib, which further worsened the fistulizing perianal disease. This was further confirmed by colonoscopy as it showed extensive ulceration from the rectum to the hepatic flexure, confirming severe colitis.
- Due to severe colitis, the patient was recommended for colectomy, and 6 months after surgery, no evidence of luminal disease, signs of active perianal disease, or systemic symptoms were observed. Therefore, she did not continue systemic treatment for CD.
- In late 2024, the patient underwent complete proctectomy, and in early 2025, she presented with a 2-month history of worsening skin lesions differing from initial presentation that started shortly after her proctectomy.
- Physical examination revealed ulcerations in the groin and gluteal cleft. She had peristomal lesions with cribriform scarring that were clinically consistent with PG. The patient then had a punch biopsy that revealed neutrophils within the epidermis, loosely scattered epithelioid granulomas, and a mixed inflammatory infiltrate within the dermis consistent with cutaneous CD.
- The patient was then treated with oral corticosteroids; however, her symptoms persisted and she was later admitted to the hospital.
- During hospitalization, the patient received an induction dose of TREMFYA 400 mg and 5 days of methylprednisolone 40 mg.
- Later, the patient was transitioned to prednisone 60 mg daily and twice-daily rifabutin 150 mg, clarithromycin 250 mg, and ciprofloxacin 500 mg. Clobetasol 0.05% was administered as topical therapy for cutaneous CD and triamcinolone 0.1% paste for peristomal PG treatment.
- Upon discharge, the patient was transitioned to TREMFYA 200 mg q4w.
- The patient completed the 30-day antimicrobial therapy and prednisone taper and remained on topical clobetasol.
- Significant improvements in the pain, drainage, and size of the groin and gluteal wounds were observed, along with resolution of the peristomal wound at 2-month follow up.
- Continued improvements in the groin and gluteal wounds were observed after 4 months of therapy and 3 doses of TREMFYA.
Literature Search
A literature search of MEDLINE®
References
| 1 | Danese S, Hisamatsu T, Rampelbergh RV, et al. Extraintestinal manifestations in participants with moderately to severely active Crohn’s disease: results from the phase 3 GALAXI 2&3 studies. Abstract presented at: 21st Congress of European Crohn’s and Colitis Organisation (ECCO); February 18–21, 2026; Stockholm, Sweden. |
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