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(guselkumab)

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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: 09/10/2026

SUMMARY

  • The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
  • The GALAXI 2 & 3 and QUASAR clinical trials reported the effects of TREMFYA on extraintestinal manifestations (EIMs) in patients with moderately to severely active Crohn's disease (CD) and ulcerative colitis (UC), respectively.1-3 
  • A case report describing the use of TREMFYA in patients with CD and EIMs is summarized below.4

CLINICAL DATA

GALAXI 2 & 3 Studies

GALAXI 2 & 3 are 2 identical 48-week, phase 3, randomized, double-blind (DB), 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.

GALAXI 2 & 3 Study Design5,6

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 EIMs

  • EIMs were reported as1:
    • A component of Crohn's disease activity index (CDAI) score at each visit
    • Individual EIM resolution, and de novo EIMs at weeks 12 and 48
  • EIM was pooled for GALAXI 2&3.
  • 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.

Pooled GALAXI 2&3 Baseline Characteristics of Patients with EIMs1
Patient Characteristic
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, n (%)
   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 biologics, 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

EIM outcomes at Week 12 Among Patients with EIM At Baseline1
EIM
TREMFYA Combined
PBO
Overall EIM resolution, %(n/N)
59.2 (119/201)
42.9 (27/63)
Overall denovo resolution, %(n/N)
2.6 (15/582)
8.1 (12/148)
Arthritis/arthralgia resolution, %(n/N)
55.3 (99/179)
33.3 (19/57)
Erythema nodosum/ Pyoderma gangrenosum resolution, %(n/N)
75.7 (28/37)
56.3 (9/16)
Abbreviations: EIM, extraintestinal manifestation; PBO, placebo.
Note: P-values at week 12 EIM outcomes at baseline were nominal. Therefore, statistical significance has not been established.

EIM Outcomes at Week 12 After Induction1
EIM
TREMFYA Combined
(N=582)
PBO
(N=148)
Baseline
Week 12
Baseline
Week 12
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; PBO, placebo.
Note: P-values at week 12 vs baseline were nominal. Therefore, statistical significance has not been established.

EIM Outcomes at Week 481
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
(0/296)
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.

Iritis/Uveitis Outcomes at Week 12 Among Patients with EIM At Baseline1
TREMFYA Combined
(N=582)
PBO
(N=148)
Iritis/Uveitis at baseline, %(n/N)
5.5 (11/201)
3.2 (2/63)
Resolution of iritis/uveitis at week 12, %(n/N)
62.5 (6/11)
100 (2/2)
Abbreviation: EIM, extraintestinal manifestation; PBO, placebo.

Iritis/Uveitis Outcomes at Week 48 Among Patients with EIM At Baseline 1
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)
Iritis/Uveitis at baseline, %(n/N)
4.3 (5/115)
7.0 (6/86)
5.5 (11/201)
Resolution of iritis/uveitis at week 48, %(n/N)
80.8 (4/5)
83.3 (5/6)
81.8 (9/11)
Abbreviations: EIM, extraintestinal manifestation; IV, intravenous; Q4W, every 4 weeks; Q8W, every 8 weeks; SC, subcutaneous.

Corticosteroid-Free EIM Outcomes at Week 481
TREMFYA 200 mg IV Q4W→100 mg SC Q8W
TREMFYA 200 mg IV Q4W→200 mg SC Q4W
TREMFYA Combined
90-Day CS-free EIM resolution at week 48-among patients with EIM at baseline
Arthritis/arthralgia, %(n/N)
68.6 (70/102)
64.9 (50/77)
67.0 (120/179)
Erythema nodosum/ Pyoderma gangrenosum, %(n/N)
91.3 (21/23)
92.9 (13/14)
91.9 (34/37)
90-Day CS-free EIM resolution at week 48-among patients with EIM who received CS at baseline
Arthritis/arthralgia, %(n/N)
68.1 (32/47)
57.6 (19/33)
63.8 (51/80)
Erythema nodosum/ Pyoderma gangrenosum, %(n/N)
87.5 (7/8)
75.0 (3/4)
83.3 (10/12)
EIM resolution at week 48-among patients with EIMs at baseline
Arthritis/arthralgia, %(n/N)
72.5 (74/102)
71.4 (55/77)
72.1 (129/179)
Erythema nodosum/ Pyoderma gangrenosum, %(n/N)
95.7 (22/23)
100 (14/14)
97.3 (36/37)
Abbreviations: CS, corticosteroids; EIM, extraintestinal manifestation; IV, intravenous; Q4W, every 4 weeks; Q8W, every 8 weeks; SC, subcutaneous.

QUASAR Study

QUASAR (NCT04033445) is a randomized, DB, PBO-controlled, parallel-group, multicenter clinical trial program that evaluated the efficacy and safety of TREMFYA during induction and maintenance studies in adults with moderately to severely active UC.2 The study design is summarized in Figure: QUASAR Program.

QUASAR Program2,3,7,8 

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Abbreviations: ADT, advanced therapy; GUS, guselkumab; HEMI, histo-endoscopic mucosal improvement; IBDQ, inflammatory bowel disease questionnaire; IV, intravenous; Q4W, every 4 weeks; Q8W, every 8 weeks; R, randomization; SC, subcutaneous; TNF, tumor necrosis factor; UC, ulcerative colitis.

aTNF alpha antagonists, vedolizumab, or tofacitinib.
bCorticosteroids or thiopurines.
cStudy treatment administered.
dPlacebo nonresponders at week 12 were given GUS IV Q4W and those who achieved clinical response at week 24 entered the maintenance study (randomized). GUS IV nonresponders at week 12 were given GUS SC 200 mg Q4W and those who achieved clinical response at week 24 entered the maintenance study (randomized).
eBetween week 8 and week 32, randomized patients meeting loss of clinical response criteria (based on the modified Mayo score and requiring a endoscopic assessment) were eligible for blinded dose adjustment as follows: Placebo SC→GUS 200 mg SC Q4W (rescue treatment), GUS 100 mg SC Q8W→GUS 200 mg SC Q4W, GUS 200 mg SC Q4W→GUS 200 mg SC Q4W (sham adjustment)
fClinical remission was defined as a Mayo stool frequency subscore of 0 or 1 that had not increased from baseline; a rectal bleeding subscore of 0; and a Mayo endoscopy subscore of 0 or 1, with no friability observed on endoscopy.
gClinical response was defined as a decrease from baseline in modified Mayo score by ≥30% and ≥2 points, with either a ≥1-point decrease from baseline in rectal bleeding subscore or a rectal bleeding subscore of 0 or 1.
hEndoscopic improvement was defined as a Mayo endoscopy subscore of 0 or 1, with no friability observed on endoscopy.
iHEMI was defined as achievement of histologic (neutrophil infiltration in <5% of crypts; no crypt destruction; and no erosions, ulcerations, or granulation tissue based on the Geboes grading system [ie, Geboes score of ≤3.1]) and endoscopic improvement.
jEndoscopic remission (normalization) was defined as an endoscopy subscore of 0.
kIBDQ remission was defined as a total IBDQ score of ≥170.
lSymptomatic remission was defined as a Mayo stool frequency subscore of 0 or 1 that had not increased from baseline and a Mayo rectal bleeding subscore of 0.

Patients with EIMs


Presence of EIMs at Baseline for Induction and Maintenance Studies2 
Induction Studya
Maintenance Studyb
Placebo IV Q4W (N=280)
TREMFYA
200 mg IV Q4W
(N=421)
Placebo SC (TREMFYA withdrawal; N=190)
TREMFYA
100 mg SC Q8W (N=188)
TREMFYA
200 mg SC Q4W (N=190)
Extraintestinal manifestation presentc, n (%)
30 (11)
60 (14)
23 (12)
22 (12)
23 (12)
Abbreviations: EIMs, extraintestinal manifestations; IV, intravenous; Q4W, every 4 weeks; Q8W, every 8 weeks; SC, subcutaneous.aValues at induction baseline for the phase 3 induction study primary efficacy population. bValues at induction baseline (in either the phase 2b or phase 3 induction study) for the phase 3 maintenance study primary efficacy population.cExtraintestinal manifestations assessed were arthritis/arthralgia, aphthous stomatitis, erythema nodosum, iritis/uveitis, primary sclerosing cholangitis, and pyoderma gangrenosum.

Clinical Remission at Week 12 and at Week 44 by Baseline EIM Status3a
Clinical Remission at Induction Week 12: Placebo IV vs TREMFYA 200 mg IV
EIM
PBO IV
N (%)
TREMFYA IV 200 mg
N (%)
Risk Difference (95% CI)b
P-valuec
Present
30 (3)
60 (15)
12 (-11 to 34)d
Nominal 0.16d
Absent
250 (8)
361 (24)
15 (10-21)
Nominal <0.001
Clinical Remission at Maintenance Week 44: Placebo SC vs TREMFYA 100 mg SC Q8W
EIM
PBO SC
N (%)
TREMFYA SC 100 mg Q8W
N (%)
Risk Difference (95% CI)b
P-valuec
Present
23 (9)
22 (50)
41 (11-64)
Nominal 0.003
Absent
167 (20)
166 (45)
24 (13-34)
Nominal <0.001
Clinical Remission at Maintenance Week 44: Placebo SC vs TREMFYA 200 mg SC Q4W
EIM
PBO SC
N (%)
TREMFYA SC 200 mg Q4W
N (%)
Risk Difference (95% CI)b
P-valuec
Present
23 (9)
23 (52)
44 (13-68)
Nominal 0.003
Absent
167 (20)
167 (50)
29 (19-40)
Nominal <0.001
Abbreviations: CI, confidence interval; EIMs, extraintestinal manifestation; IV, intravenous; JAK, Janus kinase; MES, Mayo endoscopic score; Q4W, every 4 weeks; Q8W, every 8 weeks; PBO, placebo; RBS, rectal bleeding score; SC, subcutaneous; SFS, stool frequency subscore.aClinical remission is defined as Mayo SFS of 0 or 1 and not increased from induction baseline, a Mayo RBS of 0, and an MES of 0 or 1 with no friability present on endoscopy.bRisk difference and 95% CI >0 indicated TREMFYA was better.cNominal P-value for TREMFYA vs PBO. The endpoint was not controlled for multiple comparisons. Therefore, the P-value is nominal and statistical significance has not been established.
dMantel Fleiss criterion not satisfied.

Case report

Nikzad et al (2025)4 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®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 12 August 2026.

 

References

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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. Oral Presentation presented at: 21st Congress of European Crohn’s and Colitis Organisation (ECCO); February 18–21, 2026; Stockholm, Sweden.  
2 Rubin DT, Allegretti JR, Panés J, et al. Guselkumab in patients with moderately to severely active ulcerative colitis (QUASAR): phase 3 double-blind, randomised, placebo-controlled induction and maintenance studies. Lancet. 2025;405(10472):33-49.  
3 Rubin DT, Allegretti JR, Panés J, et al. Supplement to: Guselkumab in patients with moderately to severely active ulcerative colitis (QUASAR): phase 3 double-blind, randomised, placebo-controlled induction and maintenance studies. Lancet. 2025;405(10472):33-49.  
4 Nikzad N, Khadilkar S, Onajin Darkwa O, et al. Cutaneous and genitalia inflammation treated with guselkumab and antimicrobial therapy in a patient with a history of Crohn’s disease. ACG Case Rep J. 2025;12(12):e01936.  
5 Panaccione R, Feagan BG, Afzali A, et al. Efficacy and safety of intravenous induction and subcutaneous maintenance therapy with guselkumab for patients with Crohn’s disease (GALAXI-2 and GALAXI-3): 48-week results from two phase 3, randomised, placebo and active comparator-controlled, double-blind, triple-dummy trials. Lancet. 2025;406(10501):358-375.  
6 Danese S, Afzali A, Panaccione R. Week 48 efficacy of guselkumab and ustekinumab in Crohn’s disease based on prior response/exposure to biologic therapy: results from the GALAXI 2 & 3 phase 3 studies. Am J Gastroenterol. 2024;119(10S):S741-S742. Abstract S1053.  
7 Allegretti J, Peyrin-Biroulet L, Feagan B, et al. The efficacy and safety of guselkumab induction therapy in patients with moderately to severely active ulcerative colitis: results from the phase 3 QUASAR induction study. Oral Presentation presented at: Digestive Disease Week (DDW); May 6-9, 2023; Chicago, IL.  
8 Rubin DT, Allegretti JR, Panés J, et al. The efficacy and safety of guselkumab as maintenance therapy in patients with moderately to severely active ulcerative colitis: results from the phase 3 QUASAR maintenance study. Oral Presentation presented at: Digestive Disease Week (DDW) 2024; May 18-21, 2024; Washington, DC and Virtual.  

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