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TREMFYA®

(guselkumab)

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This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.

TREMFYA® (guselkumab)

Medical Information

TREMFYA - Occurrence of Headache in Adult Patients with Moderate to Severe Plaque Psoriasis or Active Psoriatic Arthritis

Last Updated: 09/05/2025

SUMMARY  

  • Please refer to local labeling for relevant information regarding the occurrence of headache with TREMFYA in adult patients with moderate to severe plaque psoriasis or active psoriatic arthritis.
  • Among phase 3 clinical trials evaluating TREMFYA in the treatment of adult patients with moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active ulcerative colitis, and moderately to severely active Crohn’s disease during the placebo-controlled period, headache was reported as a common adverse reaction. Common was defined as the frequency of the adverse reaction 1/100 or 1/10.1 
    • Patients with moderate to severe plaque psoriasis were evaluated from an analysis of two phase 3, randomized, double-blind, placebo- and adalimumab comparator-controlled studies (VOYAGE 1 and VOYAGE 2) designed to evaluate the safety and efficacy of TREMFYA.2,3 
    • Patients with active PsA were evaluated from an analysis of two phase 3, randomized, double-blind, placebo-controlled studies (DISCOVER-1 and DISCOVER-2) designed to evaluate the safety and efficacy of TREMFYA.4,5 

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 2025.

 

References

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1 Data on File. Guselkumab. Company Core Data Sheet v022. Janssen Research & Development, LLC. EDMS-ERI-111962822; 2025.  
2 Blauvelt A, Papp K, Griffiths C, 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 3, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial. J Am Acad Dermatol. 2017;76(3):405-417.  
3 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.  
4 Deodhar A, Helliwell PS, Boehncke WH, et al. Guselkumab in patients with active psoriatic arthritis who were biologic-naive or had previously received TNFα inhibitor treatment (DISCOVER-1): a double-blind, randomised, placebo-controlled phase 3 trial [published correction appears in Lancet. 2020 Apr 4;395(10230):1114]. Lancet. 2020;395(10230):1115-1125.  
5 Mease PJ, Rahman P, Gottlieb AB, et al. Guselkumab in biologic-naive patients with active psoriatic arthritis (DISCOVER-2): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020;395(10230):1126-1136.