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SUMMARY
- The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
- Patients with guttate psoriasis were excluded from multicenter, randomized, double-blind trials assessing the safety and efficacy of TREMFYA in subjects with moderate to severe plaque psoriasis who were eligible for systemic therapy or phototherapy.1-3
- Case reports describing the use of TREMFYA in patients with guttate psoriasis are outlined below.4-6
Clinical Data
Case Reports
Abbad-Jaime de Aragón et al (2024)4 described the case of a 33-year-old male patient with guttate psoriasis that resolved after 2 doses of TREMFYA.
- The patient presented with a 4-week history of small, drop-like, erythematous papules/plaques on the trunk.
- Prior to the onset of guttate psoriasis, the patient had a 7-month history of scalp psoriasis that was treated with topical corticosteroids without any improvement.
- The patient was administered TREMFYA 100 mg subcutaneously at weeks 0 and 4. By week 8, there was complete resolution of lesions with no recurrence of psoriasis after 12 months of follow-up.
Bartholomew et al (2023)5 described the case of a 28-year-old female patient with guttate psoriasis that resolved completely after 6 doses of TREMFYA.
- During a telemedicine primary care visit, patient presented with a one-month history of small, raised, circular, pink-colored papules over the trunk and extremities. The onset of lesions occurred 1 week following a severe sunburn limited to the chest area, for which the patient was prescribed an unknown cream with no improvement.
- Subsequently, the patient visited a community dermatologist who confirmed the diagnosis of guttate psoriasis by performing a biopsy and prescribed topical clobetasol propionate 0.05%. However, the patient expressed difficulty adhering to the treatment due to numerous generalized spots and also experienced skin thinning on a few areas of the thighs after 3 months of using topical steroids without improvement.
- The patient presented to a dermatology clinic with multiple 2-4 mm, well-demarcated papules and small plaques with scale on the trunk and upper and lower extremities, with a Psoriasis Area and Severity Index (PASI) score of 6.7.
- The patient had a physician global assessment (PGA, maximum score of 5) score of 3 (moderate to severe).
- The patient enrolled in a clinical trial investigating the effect of TREMFYA on guttate psoriasis. TREMFYA 100 mg was subcutaneously administered at weeks 0, 4, 12, 20, 28, and 36.
- One month after receiving the first dose of TREMFYA, the patient had a PASI score of 0.4 and PGA score of 1 (clear/minimal).
- Eight months after the last dose of TREMFYA, the patient experienced complete remission with a PASI score of 0 and PGA score of 0 (clear).
Hall et al (2019)6 described the case of a 20-year-old female patient with guttate psoriasis that resolved after a single administration of TREMFYA.
- The patient presented to the dermatology clinic with guttate papules on the trunk and extremities and plaque-like lesions on the upper abdomen covering approximately 5% of the body surface area.
- One month prior to developing the lesions, the patient had a streptococcal throat infection and tested negative for tuberculosis.
- Patient received TREMFYA 100 mg subcutaneously and after 10 weeks, there was 100% improvement of the lesions.
- Areas of residual hypopigmentation were present where some of the previous lesions had been located with no recurrence 6 months after the patient received TREMFYA.
Literature Search
A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® databases (and/or other resources, including internal/external databases) was conducted on 02 May 2024.
1 | Janssen Research & Development, LLC. A study of guselkumab in the treatment of participants with moderate to severe plaque-type psoriasis (VOYAGE 1). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2020 [cited 2020 April 29]. Available from: https://clinicaltrials.gov/ct2/show/NCT02207231 NLM Identifier: NCT02207231. |
2 | Janssen Research & Development, LLC. A study of guselkumab in the treatment of participants with moderate to severe plaque-type psoriasis with randomized withdrawal and retreatment (VOYAGE 2). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2019 [cited 2020 April 29]. Available from: https://clinicaltrials.gov/ct2/show/NCT02207244 NLM Identifier: NCT02207244. |
3 | Janssen Research & Development, LLC. A study of guselkumab in participants with moderate to severe plaque-type psoriasis and an inadequate response to ustekinumab (NAVIGATE). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2017 [cited 2020 April 29]. Available from: https://clinicaltrials.gov/ct2/show/NCT02203032 NLM Identifier: NCT02203032. |
4 | Abbad-Jaime de Aragón C, Berna‐Rico E, Jaén P, et al. Rapid resolution of guttate psoriasis without recurrence for one year following two doses of guselkumab. Int J Dermatol. 2024;63(4):534-535. |
5 | Bartholomew E, Chung BY, Davis M, et al. Rapid remission of sunburn-induced guttate psoriasis with guselkumab. Dermatol Ther (Heidelb). 2023;13(10):2473-2478. |
6 | Hall SL, Haidari W, Feldman SR. Resolution of guttate psoriasis plaques after one-time administration of guselkumab. J Drugs Dermatol. 2019;18(8):822-823. |