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TREMFYA® (guselkumab)

Medical Information

TREMFYA – Dose Escalation During TREMFYA Maintenance Therapy in Crohn's Disease

Last Updated: 02/24/2026

SUMMARY

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The phase 3 clinical trials of TREMFYA in the treatment of adults with moderately to severely active Crohn's disease through week 48 (GALAXI and GRAVITI) 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^,²
In the GALAXI clinical trial program, patients who benefit from continued treatment, in the opinion of the investigator, were eligible to enter the long-term extension (LTE) and receive approximately 4 additional years of treatment ¹
During the LTE for the GALAXI clinical trial program, patients who met criteria for inadequate response between weeks 52 (the first visit at which treatment adjustment is permitted) and 80 (the last visit at which treatment adjustment is permitted) were eligible to receive a single-blinded dose adjustment or sham dose adjustment.¹^,³
- Efficacy and safety results of patients who received a dose adjustment in the LTE after an inadequate response through week 96 have been summarized below.³
In the GRAVITI study, at week 24, all patients entered the LTE and received the same treatment regimen they were receiving at week 24. After the last patient completed week 48 evaluations, the study was unblinded. Placebo patients who were not rescued with TREMFYA were discontinued and completed a final assessment. Other patients continued through week 248 (approximately 4 additional years of treatment). In the GRAVITI LTE, patients receiving TREMFYA did not receive a dose adjustment.²

CLINICAL DATA - GALAXI Program

Panaccione et al (2026)³ presented the efficacy and safety of TREMFYA in patients who underwent dose adjustment after an inadequate response through week 96 in the GALAXI program.

Study Design/Methods

At week 48, patients were allowed to enter the LTE on the same maintenance dose regimen (100 mg q8w or 200 mg q4w).
From weeks 52-80, patients who met inadequate response criteria (not in clinical response, defined as a ≥100point reduction from week 0 in the Crohn’s Disease Activity Index [CDAI] or a CDAI score <150, and a CDAI ≥220) received a one-time dose adjustment or sham adjustment as follows:
- TREMFYA 100 mg SC q8w group: adjusted to TREMFYA 200 mg SC q4w.
- TREMFYA 200 mg SC q4w group: remained on TREMFYA 200 mg SC q4w (sham dose adjustment).
At week 16 after dose adjustment and at week 96, clinical response (≥100-point reduction in CDAI from the time of dose adjustment or CDAI <150) and clinical remission (CDAI <150) were assessed.
Endoscopic response (≥50% improvement from week 0 in Simple Endoscopic Score for Crohn’s Disease [SES-CD] or SES-CD ≤2) and endoscopic remission (SES-CD ≤4 and ≥2-point reduction from week 0 and no subscore >1 in any individual component) were assessed at week 96.

Results

From weeks 52-80, 64 patients underwent dose adjustment to TREMFYA 200 mg q4w (36 switched from 100 mg q8w; 28 received a sham adjustment). Overall, 78.1% of patients had undergone dose adjustment by week 64. Of these 64 patients, 53 were eligible for efficacy analyses; 11 were excluded as they continued treatment and entered the LTE despite meeting discontinuation criteria before week 48.
Clinical and endoscopic outcomes among patients who received a dose adjustment are summarized in the Table: Clinical and Endoscopic Outcomes through Week 96. Efficacy outcomes in TREMFYA 200 mg q4w patients who received a sham dose adjustment were generally similar to those observed in patients who switched from TREMFYA 100 mg q8w to 200 mg q4w.

Clinical and Endoscopic Outcomes through Week 96³

	TREMFYA
	100mg SC q8w (N=29)	100mg SC q8w → 200 mg SC q4w (N=29)		200mg SC q4w → 200 mg SC q4w (N=24)
	Week 48	16 weeks after dose adjustment	Week 96	Week 48	16 weeks after sham dose adjustment	Week 96
Clinical response,^a n (%)	-	12 (41.4)	17 (58.6)	-	11 (45.8)	12 (50.0)
Clinical remission,^b n (%)	-	9 (31.0)	14 (48.3)	-	9 (37.5)	10 (41.7)
Endoscopic response,^c n (%)	9 (31.0)	-	14 (48.3)	8 (33.3)	-	16 (66.7)
Endoscopic remission,^d n (%)	4 (13.8)	-	10 (34.5)	5 (20.8)	-	9 (37.5)
Note: Endoscopic response and endoscopic remission were assessed before (week 48) and after dose adjustment (week 96) among patients treated with TREMFYA who received dose adjustment between weeks 52-80. No patient was in clinical remission or clinical response at the time of dose adjustment per criteria for dose adjustment (not in clinical response [≥100-point reduction in CDAI from the time of dose adjustment or CDAI <150] and CDAI ≥220). Abbreviations: CDAI, Crohn’s Disease Activity Index; q4w, every 4 weeks; q8w, every 8 weeks; SC, subcutaneous; SES-CD, Simple Endoscopic Score for Crohn’s Disease. ^aClinical response is defined as ≥100-point reduction in CDAI from the time of dose adjustment or CDAI <150. ^bClinical remission is defined as CDAI <150. ^cEndoscopic response is defined as ≥50% improvement from week 0 in SES-CD or SES-CD ≤2. ^dEndoscopic remission is defined as SES-CD ≤4 and ≥2-point reduction from week 0 and no subscore >1 in any individual component.

Adverse event rates were comparable before and after dose adjustment during the LTE, see Table: Overall Summary of Adverse Events from Weeks 48-96 Among Patients Who Received a Dose Adjustment in the LTE.

Overall Summary of Adverse Events from Weeks 48-96 Among Patients Who Received a Dose Adjustment in the LTE³

	TREMFYA
	Randomised treatment and up to dose adjustment	After dose adjustment^b,c	Randomised treatment and up to dose adjustment	After sham dose adjustment^b,c
	100 mg q8w^a	100 mg q8w → 200 mg q4w	200 mg q4w^a	200 mg q4w → 200 mg q4w
N	36	36	28	28
Average duration of follow-up, weeks	12.1	33.6	12.9	33.1
PYs of follow-up	8.3	23.2	6.9	17.7
≥1 AE, n (%)	19 (52.8)	24 (66.7)	14 (50.0)	15 (53.6)
Events per 100 PYs (95% CI)^d	360.7 (243.4-514.9)	341.1 (270.0-425.1)	519.1 (363.6-718.7)	484.6 (387.6-598.5)
≥1 serious AE, n (%)	0	3 (8.3%)	1 (3.6)	1 (3.6%)
Events per 100 PYs (95% CI)^d	0.0 (0.0-36.0)	13.0 (2.7-37.8)	14.4 (0.4-80.3)	5.6 (0.1-31.4)
≥1 AE leading to discontinuation, n (%)	0	2 (5.6)	1 (3.6)	0
Events per 100 PYs (95% CI)^d	0.0 (0.0-36.0)	17.3 (4.7-44.2)	14.4 (0.4-80.3)	0.0 (0.0-16.9)
≥1 infection, n (%)	7 (19.4)	12 (33.3)	4 (14.3)	9 (32.1)
Events per 100 PYs (95% CI)^d	120.2 (57.7-221.1)	77.7 (46.1-122.8)	72.1 (23.4-168.3)	84.5 (47.3-139.4)
≥1 serious infection, n (%)	0	1 (2.8)	0	0
Events per 100 PYs (95% CI)^d	0.0 (0.0-36.0)	4.3 (0.1-24.1)	0.0 (0.0-43.2)	0.0 (0.0-16.9)
Death, n (%)	0	0	0	0
Note: Patients are counted only once for any given events, regardless of the number of times they actually experienced the event. AEs are coded using MedDRA version 27.0. Abbreviations: AE, adverse events; CI, confidence interval; MedDRA, Medical Dictionary for Regulatory Activities; PYs, patient-years; q4w, every 4 weeks; q8w, every 8 weeks; SC, subcutaneous. ^aTreatment group at the start of the long-term extension. Includes events for patients who received a dose adjustment from week 48 up to the time point of dose adjustment, and all events from week 48 through week 96 for patients who never received a dose adjustment. ^bPatients receiving TREMFYA 100 mg SC q8w who met inadequate response criteria between week 52 and week 80 had a dose adjustment to TREMFYA 200 mg SC q4w. Patients receiving TREMFYA 200 mg SC q4w who met the inadequate response criteria between weeks 52-80 received a “sham” dose adjustment. ^cOnly events after dose adjustment (including “sham”) are included in this column. ^dCI based on an exact method assuming that the observed number of events follows a Poisson distribution.

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 28 January 2026.

References

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1	Data on File. Guselkumab. Clinical Protocol CNTO1959CRD3001. Janssen Research & Development, LLC. EDMS-ERI-136754231; 2022.
2	Data on File. Guselkumab. Protocol CNTO1959CRD3004. Janssen Research and Development, LLC. EDMS-ERI-163296; 2025.
3	Panaccione R, Hisamatsu T, Afzali A, et al. Efficacy and safety of guselkumab in participants with moderately to severely active Crohn’s disease who had maintenance dose adjustment: results from the phase 3 GALAXI 2 & 3 long-term extension [abstract]. J Crohns Colitis. 20(Supplement_1):i1621-i1623. Abstract P046.

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