SUMMARY

• The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
• A phase 3 study, retrospective study, and case reports described TREMFYA treatment in patients with erythrodermic psoriasis (EP).^1-4

clinical Data

Phase 3 Study

Sano et al (2018)¹ reported results from a phase 3, single-arm, open-label study evaluating the efficacy and safety of TREMFYA in Japanese patients with general pustular psoriasis (GPP) and EP from 23 sites in Japan.

Study Design/Methods

• Select inclusion criteria: patients ≥20 years of age diagnosed with GPP (Japan Dermatology Association [JDA] severity index <14) or with EP having lesions covering more than 80% of the body surface area (BSA); patients who were candidates for phototherapy or systemic treatment for psoriasis; patients who have a history of plaque type psoriasis.
• Select exclusion criteria: patients with guttate psoriasis; drug-induced psoriasis; history of malignancy within 5 years of screening; history or current signs of any severe, progressive or uncontrolled medical conditions; prior treatment with adalimumab within 8 weeks, infliximab within 12 weeks, agents targeting interleukin (IL)-12, IL-17, or IL-23 within 6 months; granulocyte and monocyte apheresis therapy within 3 months; or systemic immunosuppressants or phototherapy within 4 weeks.  
• TREMFYA 50 mg was administered subcutaneously (SC) at weeks 0, 4, and every 8 weeks (q8w) until week 52.
• Dose escalation to TREMFYA 100 mg q8w was permitted for patients with Clinical Global Impression (CGI) rating of “no change” or “worsened” at any scheduled study visit beginning at week 20, as well as for patients with CGI “minimally improved” depending on investigator discretion.
• Concomitant topical therapies were permitted throughout the study and methotrexate, or retinoids were allowed if initiated 1 week before the first administration of TREMFYA.
• The primary efficacy endpoint was the proportion of patients achieving treatment success, defined as “very much improved,” “much improved,” or “minimally improved” CGI scores (based on 7-point scale) at week 16.
• Secondary efficacy endpoints were assessed through week 52 and included:
  • Proportion of patients achieving treatment success over time
  • Change from baseline in JDA severity index total score for patients with GPP
  • Change from baseline in BSA involvement for patients with EP
  • Proportion of patients achieving an Investigator’s Global Assessment (IGA) score of cleared or minimal (0/1)
  • Percentage improvement in Psoriasis Area and Severity Index (PASI)
  • Change from baseline in the Dermatology Life Quality Index (DLQI)
  • Percentage of patients achieving DLQI 0/1 among those with a baseline DLQI score of ≥1
  • Percentage of patients with a reduction of 5 points or more in the DLQI
  • Change from baseline in the Physical Component Scores (PCS), Mental Component Scores (MCS) of the 36-item Short-Form Health Assessment Questionnaire (SF-36)
• Safety was monitored until the week-52 database lock.
• All patients who received at least one dose of TREMFYA were included in both the efficacy and safety analysis. Missing data were treated as such, and imputation was not employed.

Results

Patient Characteristics

• Twenty-one patients (EP, n=11) were enrolled in the study and of these patients, 18 completed the week-52 visit (EP, n=10).
• One patient with EP withdrew consent to participate.
• The mean age of patients in the study was 48.9 years and 76.2% of patients were male.
• The median disease duration was 9 years (range, 0-35 years).
• Patients with EP had a median BSA of 85% (range, 80-97%) at baseline.

Efficacy

• A total of 10 (90.9%) EP patients achieved treatment success (CGI “very much improved” [n=5, 45.5%] or “much improved” [n=3, 27.3%] or “minimally improved” [n=2, 18.2%]) at week 16.
• At week 20, 2 patients with EP underwent dose escalation.
  • Treatment success was achieved by one patient at week 20 and by both patients at week 52.
• Secondary efficacy outcomes of GPP patients are shown in Table: Secondary Efficacy Outcomes of TREMFYA Treatment in Patients with Erythrodermic Psoriasis through Week 52.

Safety

• Treatment-emergent adverse events (TEAE) through week 52 are shown in Table: Safety Outcomes of TREMFYA Treatment with Erythrodermic Psoriasis through Week 52.

• All TEAEs were mild to moderate in severity.
• No deaths or injection-site reactions were reported.
• There was no new occurrence of psoriasis observed in any patient through week 52.

Retrospective Study

Chiang et al (2021)² studied the efficacy of TREMFYA in EP patients who were previously treated with conventional treatment or other biologics in a retrospective Taiwanese study.

Methods

• EP was defined as psoriasis involving more than 80% BSA for this study.
• Patients with EP (n=13) met the criteria of EP before TREMFYA use. All except 1 of the patients had plaque-type psoriasis prior to EP diagnosis.
• Due to inadequate response to previous treatment (conventional oral systemic agents, phototherapy, biologics), they were switched to TREMFYA without a washout period.
  • Not every patient’s BSA involvement exceeded 80% when they started TREMFYA treatment.
• Patients received TREMFYA 100 mg at weeks 0, 4, and q8w until at least week 28.
• PASI response and TEAEs were evaluated at each visit.

Results

• The patient population included a total of 13 patients (male, n=12; female, n=1).
• Mean±SD baseline PASI was 23.8±9.7.
• TREMFYA efficacy outcomes are shown in Table: TREMFYA PASI Efficacy Outcomes through Week 28.

• PASI 50 nonresponders (n=5, 38.5%) showed decreasing PASI improvement through week 28.
  • One patient was prescribed cyclosporine at week 12.
  • Four patients switched to other biologics (one patient switched to brodalumab at week 12; three patients switched to adalimumab, brodalumab, and ixekizumab, respectively, at week 28).
• No nasopharyngitis, headache, upper respiratory tract infection, or injection-site reaction were reported through week 36.

Case Reports

Welsh et al (2023)³ described two cases of patients with EP who were successfully treated with TREMFYA.

• Case 1: A 65-year-old female presented with a 4-year history of psoriasis.
  • Dermatological examination showed symmetrical erythematous scaly plaques; BSA involvement was >90%; punch biopsy was compatible with psoriasis.
  • Previous treatment included topical steroids.
  • Patient was treated with TREMFYA 100 mg SC at weeks 0, 4 and q8w thereafter, topical steroids and emollients.
  • Patient achieved a complete response (PASI 100) by week 12, which was maintained for over 32 months.
• Case 2: A 51-year-old male presented with a 1-year history of plaque-type psoriasis.
  • Patient presented with erythematous plaques on his extremities and trunk that spread to a PASI 40.
  • Histopathological analysis was compatible with psoriasis.
  • Previous treatment included topical steroids.
  • Patient was treated with TREMFYA and achieved a complete response by week 12, which was maintained through 2 years.

Megna et al (2020)⁴ described a case of a patient with EP who was treated successfully with TREMFYA.

• A 38-year-old Caucasian male presented with erythematous-desquamative plaques.
• Dermatological examination confirmed EP: generalized erythema of the entire skin body area with associated desquamation (PASI 48, BSA 92%).
• Previous treatment included topical therapies and acitretin with only partial, transitory disease improvement.
• Previous medical history of non-Hodgkin lymphoma excluded anti-tumor necrosis factor alpha treatment.
• Patient was treated with TREMFYA 100 mg SC at weeks 0, 4 and q8w thereafter.
• Patient achieved PASI 100 after 20 weeks of therapy which was maintained through week 48, without experiencing any adverse events.

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 16 April 2024.