SUMMARY

• The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
• Clinical trials have not been conducted to evaluate the efficacy and safety of TREMFYA in patients undergoing surgery.
• The joint American Academy of Dermatology (AAD) and National Psoriasis Foundation (NPF) guidelines of care for the management and treatment of psoriasis with biologics provides treatment guideline recommendations for patients with psoriasis or psoriatic arthritis, including biologic use and surgery.¹

clinical Data

Adult Plaque Psoriasis TREMFYA Clinical Trials (VOYAGE 1, VOYAGE 2, NAVIGATE, and ORION)^2-5

• Patients were excluded from participation in clinical trials if they had major surgery (eg, requiring general anesthesia and hospitalization) within 8 weeks before screening, or had not fully recovered from such surgery, or had such surgery planned during the time the patient was expected to participate in the clinical trial.
  • Patients with planned surgical procedures to be conducted under local anesthesia may have been able to participate.

GUIDELINE SUMMARY

Menter et al (2019)¹ provides treatment guideline recommendations for patients with psoriasis or psoriatic arthritis, including biologic use and surgery.

Methods

The joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics were updated by a multidisciplinary working group of psoriasis experts consisting of dermatologists, a rheumatologist, a cardiologist, and representatives from a patient advocacy organization.

An evidence-based model was used for clinical questions addressed in the previous version of this guideline, published in 2008-2011, and for all newly identified clinical questions. Evidence was obtained using a search of the PubMed and MEDLINE databases from January 1, 2008 to December 31, 2017. Search was limited to publications in the English language.

Clinical recommendations were developed on the basis of best available evidence. For situations in which documented evidence were not available, expert opinion was utilized to generate clinical recommendations or opted not to issue a recommendation.  

Biologics and Surgery

• Based on expert opinion, patients with psoriasis and psoriatic arthritis undergoing a low-risk surgical procedure can continue use of all biologics.
• Low-risk procedures are defined as surgical procedures without a break in sterile technique during which the respiratory, gastrointestinal, and genitourinary tracts are not entered. Moderate- and high-risk procedures include those in which the respiratory, gastrointestinal, or genitourinary tract is entered without the presence of contamination and those in which there is no major break in sterile technique, spillage from the gastrointestinal tract, or an active infection or devitalized tissue. See table: Perioperative Risk Stratification.
• Moderate- and high-risk procedures require case-by-case consideration with the surgeon(s)/medical team and risk assessment should consider each patient’s individual risk factors and comorbidities.
• If necessary, the biologic agent could be discontinued approximately 3-4 half-lives before and until 1-2 weeks after elective surgery if there are no postoperative complications.  

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® databases (and/or other resources, including internal/external databases) was conducted on 10 April 2024.