(guselkumab)
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TREMFYA® (guselkumab)
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TREMFYA - Occurrence of Infections in Adult Patients with Crohn’s Disease or Ulcerative Colitis
Last Updated: 09/13/2024
SUMMARY
- The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
- The safety and efficacy of TREMFYA in adults with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) were evaluated in the QUASAR and GALAXI clinical trial program, respectively. Summarized below is infection data from these 2 programs.1
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CLINICAL DATA – CROHN’S DISEASE
Phase 3 Clinical Studies- GALAXI 2 and 3
Panaccione et al (2024)1 reported the safety of TREMFYA in adult patients with moderately to severely active CD through GALAXI 2 and 3. GALAXI 2 and 3 were 2 identically designed, randomized, double-blind, active comparator, placebo-controlled treat-through trials.
For the occurrence of infections, please see Table: Occurrence of Tuberculosis, Opportunistic Infections, And Serious Infections Through Week 48 of GALAXI 2 And 3 (Pooled Results).
| TREMFYA 200 mg IV Q4W→100 mg SC Q8W | TREMFYA 200 mg IV Q4W→200 mg SC Q4W | Ustekinumab ~6 mg/kg IV→90 mg SC Q8W | Placebo IV→SCa | |
|---|---|---|---|---|
| All-treated safety analysis set, N | 296 | 299 | 300 | 153 |
| Average duration of follow-up (weeks) | 46.2 | 46.7 | 45.5 | 21.8 |
| Participants with ≥1b | ||||
| Tuberculosis, n (%) | 1 (0.3) | 0 | 0 | 0 |
| OIs, n (%) | 1 (0.3) | 2 (0.7) | 0 | 1 (0.7) |
| Serious Infectionc | 1 (0.3) | 3 (1) | 12 (4) | 2 (1.3) |
| Abbreviation: IV, intravenous; MedDRA, Medical Dictionary for Regulatory Activities; OI, opportunistic infection; Q4W, every 4 weeks; Q8W, every 8 weeks; SC, subcutaneous. aEvents attributed to participants randomized to placebo, except where a participant is randomized to placebo and cross over to ustekinumab (events occurring after receiving ustekinumab are not counted). bParticipants are counted only once for any given event, regardless of the number of times they experienced the event. Adverse events are coded using the MedDRA 26.0. cInfections defined as any adverse event coded to MeDRA organ class “Infections and infestations”. | ||||
- Through Week 48 of the GALAXI 2 and 3 studies, COVID-19 and upper respiratory tract infection were among the 5 most frequently reported adverse events in patients receiving TREMFYA.
CLINICAL DATA – ULCERATIVE COLITIS
QUASAR Phase 3 Studies
The safety of TREMFYA was evaluated through 2 phase 3, randomized, double-blind, placebo-controlled, studies in adult patients with moderately to severely active UC (QUASAR). This included a 12-week induction study and a 44-week randomized, withdrawal maintenance study.2
For the occurrence of infections in TREMFYA-and placebo placebo-treated patients in the induction study, please see Table: Occurrence of Infections in the QUASAR Induction Study.
| TREMFYA 200 mg IV | Placebo IV | |
|---|---|---|
| Safety analysis set, N | 421 | 280 |
| Participants with ≥1 | ||
| Infectionsa, n (%) | 66 (15.7) | 43 (15.4) |
| Serious infectionsa, n (%) | 3 (0.7) | 1 (0.4) |
| Abbreviation: IV, intravenous; MedDRA, Medical Dictionary for Regulatory Activities. aInfections were defined as any adverse event that was coded to the MedDRA system organ class ‘Infections and infestations.’ | ||
- Through week 12 of the induction study, COVID-19 was one of the most common adverse events among TREMFYA-treated patients (5%, TREMFYA vs 4.3%, placebo).
For the occurrence of infections through the 44-week maintenance study, please see Table: Occurrence of Tuberculosis, Infections, Serious Infections, And Opportunistic Infections Through Week 44 of the QUASAR Maintenance Study.
| Randomized TREMFYA | Randomized Placebo (TREMFYA Withdrawal) | ||
|---|---|---|---|
| 100 mg Q8W | 200 mg Q4W | ||
| Randomized safety analysis set, N | 186 | 190 | 192 |
| Average duration of follow-up (weeks) | 40.5 | 39.2 | 34 |
| Participants with ≥1 | |||
| Tuberculosis | 0 | 0 | 0 |
| Infectionsa, n (%) | 59 (31.7) | 59 (31.1) | 63 (32.8) |
| Serious infectionsa, n (%) | 1 (0.5) | 2 (1.1) | 0 |
| Opportunistic infectionsa,b | 0 | 0 | 0 |
| Abbreviation: Q4W, every 4 weeks; Q8W, every 8 weeks. aIncludes only patients with modified Mayo score 5-9 at induction baseline who are randomized in the maintenance study and data up to the time of dose adjustment for patients who underwent dose adjustment. bPatients were counted only once for any given document. | |||
- Through week 44 of the maintenance study, COVID-19 was one of the most common adverse events among TREMFYA-treated patients (11.2%, TREMFYA vs 14.1%, placebo).
Literature Search
A literature search of MEDLINE®
References
| 1 | Panaccione R, Danese S, Feagan B, et al. Efficacy and safety of guselkumab therapy in patients with moderately to severely active Crohn’s disease: results of the GALAXI 2 & 3 phase 3 studies. Oral Presentation presented at: Digestive Disease Week (DDW); May 18-21, 2024; Washington, DC and Virtual. |
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