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TREMFYA® (guselkumab)

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Occurrence of Weight Gain in Adult Patients with Plaque Psoriasis or Psoriatic Arthritis

Last Updated: 01/04/2025

SUMMARY  

  • Please refer to local labeling for relevant information regarding TREMFYA and the occurrence of weight gain.
  • Data on the occurrence of weight gain from phase 3 clinical trials of TREMFYA in adult patients with moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy, or active psoriatic arthritis (PsA), are summarized below.1-8

CLINICAL DATA IN MODERATE TO SEVERE PLAQUE PsO

VOYAGE 1

Blauvelt et al (2017)9 evaluated the efficacy and safety of TREMFYA compared with placebo and adalimumab in patients with moderate to severe plaque PsO.

  • Through week 16, there were no reports of weight gain in the TREMFYA and placebo groups. Weight gain was reported in 1/333 (0.3%) patients in the adalimumab group.1
  • Additionally, the mean increase in weight from baseline to week 264 was 2.0 kg, 2.3 kg, and 2.1 kg in the TREMFYA, adalimumab→TREMFYA, and combined TREMFYA groups, respectively.2

VOYAGE 2

Reich et al (2017)10 evaluated the efficacy and safety of TREMFYA compared with placebo and adalimumab in patients with moderate to severe plaque PsO.

  • The mean increase in weight from baseline to week 264 was 2.7 kg in the TREMFYA group and 2.2 kg in the adalimumab→TREMFYA group.3

Pooled Safety Analysis - VOYAGE 1 and VOYAGE 2

Blauvelt et al (2022)11 conducted a pooled safety analysis of the VOYAGE 1 and VOYAGE 2 studies through week 264 (5 years) in patients with moderate to severe plaque PsO.


Incidence of Weight Gain Through Week 264 in Patients Treated with TREMFYA in VOYAGE 1 and VOYAGE 24
Adverse Event, n (%)
TREMFYAa
(n=1221)
Adalimumab→TREMFYA
(n=500)
Combined TREMFYA
(n=1721)
Weight gain
14 (1.1)
9 (1.8)
23 (1.3)
aPlacebo crossover patients were included in the TREMFYA group after crossover to TREMFYA.

NAVIGATE

Langley et al (2018)12 evaluated the safety of TREMFYA in NAVIGATE, an active comparator-controlled study in patients with moderate to severe PsO with an inadequate response to ustekinumab.

  • From week 16 through week 60, weight gain was reported in 2/135 (1.5%) patients in the TREMFYA group. There were no reports of weight gain in the ustekinumab group.5

ECLIPSE

Reich et al (2019)13 reported results from ECLIPSE, a head-to-head study of TREMFYA and secukinumab in adults with moderate to severe plaque PsO.

  • Through week 56, weight gain was reported in 1/534 (0.2%) patients in the TREMFYA group and 1/511 (0.2%) patients in the secukinumab group.6

CLINICAL DATA IN ACTIVE PsA

DISCOVER-1 and DISCOVER-2

Rahman et al (2021)14 conducted a pooled safety analysis of the phase 3 DISCOVER-1 and DISCOVER2 studies through 1 year in patients with active PsA.


Incidence of Weight Gain Through 1 Year in Patients Treated with TREMFYA in DISCOVER-1 and DISCOVER-27
Adverse Event,
n (%)
PBO-Controlled Period Through Week 24a
Reporting Period Through 1 Year
PBOb
(n=372)
TREMFYA
TREMFYA
100 mg q8w
(n=375)
100 mg q4w
(n=373)
Combined
(n=748)
100 mg q8w
(n=375)
100 mg q4w
(n=373)
PBO→100 mg q4wc
(n=352)
Combined
100 mg q4wc
(n=725)
All Combinedc
(N=1100)
Weight gain
1 (0.3)
4 (1.1)
0
4 (0.5)
4 (1.1)
0
1 (0.3)
1 (0.1)
5 (0.5)
Abbreviations: PBO, placebo; q4w, every 4 weeks; q8w, every 8 weeks.
aFor patients in all treatment groups who discontinued study treatment early with the last study treatment (PBO or TREMFYA) administered prior to week 24 and who did not receive any study treatment (PBO or TREMFYA) at or after week 24, all data including the final safety follow-up visit collected through 1 year were included in this period.
bFor patients in the PBO group who changed treatment from PBO to TREMFYA due to crossover or inadvertently, only data prior to the first administration of TREMFYA were included in this group. Data on and after the first administration of TREMFYA were not included in this group.
cFor patients in the PBO group who changed treatment from PBO to TREMFYA due to crossover or inadvertently, only data on and after the first administration of TREMFYA were included in this group. Data prior to the first administration of TREMFYA were not included in this group.

DISCOVER-2

McInnes et al (2022)15 evaluated the safety of TREMFYA compared with placebo in biologic-naïve patients with active PsA through week 112 (2 years) in the DISCOVER-2 study.


Incidence of Weight Gain Through Week 112 in Patients Treated with TREMFYA in DISCOVER-28
Adverse Event,
n (%)
PBO-Controlled Perioda
Through End of Study
PBOb
(n=246)
TREMFYA
TREMFYA
100 mg q8w
(n=248)
100 mg q4w
(n=245)
Combined
(n=493)
100 mg q8w
(n=248)
100 mg q4w
(n=245)
PBO→100 mg q4wc
(n=238)
Combined
100 mg q4wc
(n=483)
All Combinedc
(N=731)
Weight gain
1 (0.4)
2 (0.8)
0
2 (0.4)
3 (1.2)
0
2 (0.8)
2 (0.4)
5 (0.7)
Abbreviations: PBO, placebo; q4w, every 4 weeks; q8w, every 8 weeks.
aInclude all data collected during the PBO-controlled period through week 24. An exception is made for patients in all treatment groups who discontinued study treatment early with the last study treatment (PBO or TREMFYA) administered prior to week 24 and did not receive any study treatment (PBO or TREMFYA) at or after week 24, with additional follow-up after week 24, which are included in this period.
bFor patients in the PBO group who received TREMFYA at week 24 or another time point, only data prior to the first administration of TREMFYA were included in this group. Data on or after the first administration of TREMFYA were not included in this group.
cFor patients in the PBO group who received TREMFYA at week 24 or another time point. Only data on or after the first administration of TREMFYA were included in this group. Data prior to the first administration of TREMFYA were not included in this group.

Literature Search

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 12 July 2024.

 

References

Show
1 Data on File. Clinical Study Report CNTO1959PSO3001. Janssen Research & Development, LLC. EDMS-ERI-204857060; 2016.  
2 Data on File. Clinical Study Report CNTO1959PSO3001. Janssen Research & Development, LLC. EDMS-RIM-714706; 2021.  
3 Data on File. Clinical Study Report CNTO1959PSO3002. Janssen Research & Development, LLC. EDMS-RIM-714711; 2021.  
4 Data on File. Summary of Clinical Safety CNTO1959PSO3001 and CNTO1959PSO3002. Janssen Research & Development, LLC. EDMS-RIM-107300; 2021.  
5 Data on File. Clinical Study Report CNTO1959PSO3003. Janssen Research & Development, LLC. EDMS-ERI-135410939; 2016.  
6 Data on File. Clinical Study Report CNTO1959PSO3009. Janssen Research & Development, LLC. EDMS-RIM-293525; 2019.  
7 Data on File. Integrated Summary of Safety CNTO1959PSA3001 and CNTO1959PSA3002. Janssen Research & Development, LLC. EDMS-RIM-867843; 2020.  
8 Data on File. Clinical Study Report CNTO1959PSA3002. Janssen Research & Development, LLC. EDMS-RIM-476412; 2021.  
9 Blauvelt A, Papp KA, Griffiths CE, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial. J Am Acad Dermatol. 2017;76(3):405-417.  
10 Reich K, Armstrong AW, Foley P, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to severe psoriasis with randomized withdrawal and retreatment: results from the phase III, double-blind, placebo- and active comparator-controlled VOYAGE 2 trial. J Am Acad Dermatol. 2017;76(3):418-431.  
11 Blauvelt A, Tsai TF, Langley RG, et al. Consistent safety profile with up to 5 years of continuous treatment with guselkumab: pooled analyses from the phase 3 VOYAGE 1 and VOYAGE 2 trials of patients with moderate-to-severe psoriasis. J Am Acad Dermatol. 2022;86(4):827-834.  
12 Langley RG, Tsai TF, Flavin S, et al. Efficacy and safety of guselkumab in patients with psoriasis who have an inadequate response to ustekinumab: results of the randomized, double-blind, phase 3 NAVIGATE trial. Br J Dermatol. 2018;178(1):114-123.  
13 Reich K, Armstrong AW, Langley RG, et al. Guselkumab versus secukinumab for the treatment of moderate-to-severe psoriasis (ECLIPSE): results from a phase 3, randomised controlled trial. Lancet. 2019;394(10201):831-839.  
14 Rahman P, Ritchlin CT, Helliwell PS, et al. Pooled safety results through 1 year of 2 phase III trials of guselkumab in patients with psoriatic arthritis. J Rheumatol. 2021;48(12):1815-1823.  
15 McInnes IB, Rahman P, Gottlieb AB, et al. Long-term efficacy and safety of guselkumab, a monoclonal antibody specific to the p19 subunit of interleukin-23, through two years: results from a phase III, randomized, double-blind, placebo-controlled study conducted in biologic-naive patients with active psoriatic arthritis. Arthritis Rheumatol. 2022;74(3):475-485.