SUMMARY

• The company cannot recommend any practices, procedures or usage that deviate from the approved labeling.
• Case reports describing the use of TREMFYA in pediatric patients with plaque psoriasis are reported.^1,2
• No data was found regarding the use of TREMFYA in pediatric patients with psoriatic arthritis.

CLINICAL DATA

Song EJ et al (2021)¹ described the case of a 13-year-old female from Guatemala with no known medical or family history who presented with widespread plaque psoriasis (body surface area [BSA] involvement of 12% and static investigator global assessment [IGA] score of 3).

• No sufficient plaque psoriasis improvement was seen with prior ultrapotent topical steroids and methotrexate treatment.
• Patient tested positive for hepatitis B surface antigen, hepatitis B core antibodies, and hepatitis B envelope antibodies, but negative for hepatitis B envelope antigen and hepatitis B surface antibodies.
• HBV deoxyribonucleic acid (DNA) load was 3.4 IU/mL (log 10).
• Liver function tests (aspartate aminotransferase [AST], 24; and alanine aminotransferase [ALT], 23) and alpha-fetoprotein were in normal ranges.
• Ustekinumab 45 mg subcutaneous (SC) and entecavir 0.5mg daily were initiated.
• Six weeks after initiation of ustekinumab, a slight increase in liver enzymes (aspartate aminotransferase [AST], 51; alanine aminotransferase [ALT], 77) and decrease in viral load (2.4 IU/mL [log 10]) were seen with no reported or observed abdominal pain, jaundice, itching or flu-like symptoms.
• At the 28-week follow-up with treatment of ustekinumab, the patient presented to a dermatologist with a 7% BSA involvement and an IGA score of 3 and was then switched to TREMFYA 100 mg SC.
• Following one dose of TREMFYA (4-week follow-up), the patient had 3% BSA and an IGA score of 3.
• At 12-weeks with treatment of TREMFYA, the patient had 1% BSA with an IGA score of 2. Her liver enzymes remained stable (AST, 26; ALT, 42) and viral load was undetectable.    

Kim et al (2019)² described the case of a 12-year-old female patient who presented with a 6-month history of plaque psoriasis.

• Minimal improvement was achieved with prior treatment of medium- and high-potency topical steroids.
• Narrow-band ultraviolet B phototherapy had been discontinued due to difficulty in attending treatment sessions.
• On physical exam, she presented with diffuse pink-red scaly plaques involving the scalp, forehead, trunk, buttocks, and upper and lower extremities involving >50% BSA with a Psoriasis Area Severity Index (PASI) score of 31.
• Additionally, she had pitting of multiple fingernails but no dactylitis or joint swelling.
• Treatment was initiated with methotrexate (MTX) 15 mg (0.4 mg/kg) weekly with minimal response seen at 4 months.
• She was switched to adalimumab treatment for 10 weeks, followed by ustekinumab treatment for 16 weeks, both without improvement.
• MTX was reinstituted at 20 mg weekly (0.3 mg/kg, given interval weight gain).
• TREMFYA 100 mg SC at week 0 and week 4, then every 8 weeks was added to MTX treatment after initial screening labs were all within normal ranges.
• Her plaques started to thin as early as week 4, and given the improvement at week 8, MTX was decreased to 10 mg (0.16 mg/kg) weekly.
• At 5 months, most plaques had resolved with postinflammatory hyperpigmentation. Her PASI score was reduced to 1 and MTX continued to be tapered.
• No adverse effects or laboratory abnormalities during TREMFYA treatment were reported.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 30 May 2024.