Review Identifies Criteria Used to Define Anti–TNF-α Failure in Patients With Psoriasis

Results of a recent systematic literature review suggest the need to standardize management of anti–tumor necrosis factor-α (anti–TNF-α) failure in patients with psoriasis and reflect the incorporation of new targets like interleukin (IL) inhibitors in the treatment sequence.

Findings were published in Annals of Medicine.

As therapeutic options for moderate to severe psoriasis have increased significantly in recent years, choosing the appropriate treatment option for each patient can be a challenge, authors explained.

“More recently, the availability of anti–TNF-α biosimilars has provided a less costly alternative to their precursors, facilitating the access to anti–TNF-α as a first-line biologic treatment for moderate to severe plaque psoriasis,” they added.

However, around 20% of patients discontinue their first course of anti–TNF-α and discontinuation rates rise over time. This is due in large part to a failure to respond to treatment. It’s also difficult to predict or determine patients’ response to anti–TNF-α in routine practice.

To gather information on the criteria used to define treatment failure, the researchers carried out a systematic literature review.

Fifty-eight publications were included in the review, of which 37 (63.8%) described the criteria used to define anti–TNF-α primary or secondary failure. The studies were gleaned from international and Spanish national databases.

Analyses revealed:

• Criteria varied across studies, although around 60% considered Psoriasis Area and Severity Index (PASI) 50 criteria
• 19 studies (32.8%) reported the reasons for treatment failure, including the lack or loss of efficacy and safety-related problems, mainly infections
• 29 publications (50%) outlined the treatments administered after anti–TNF-α: 62.5% reported a switch to another anti–TNF-α and 37.5% to IL inhibitors

Most studies also failed to consider patient-reported outcomes when assessing psoriasis treatment efficacy, the authors said, a finding “which contrasts with recent recommendations on the inclusion of patient-reported [health-related quality of life] as a supporting criterion when considering clinical outcomes.”

Reasons for anti–TNF-α discontinuation varied among studies, and efficacy and safety-related issues were the most common. However, results suggest other factors like patients’ preferences should be considered, authors said.

Of the 58 included studies, the majority were observational studies, 16 were clinical trials, 3 were clinical practice guidelines, and 1 corresponded to a narrative review. Twenty-three observational studies had a retrospective design and the rest had a prospective design. The authors applied the 30-point Consolidated Standards of Reporting Trials statement for randomized clinical trials included in the review.

Researchers also noted the predominance of PASI 50 in the included studies implies stricter criteria, like the PASI 75, were underused. Less than 20% of studies used the strictest criteria, PASI9 0 or Physician’s Global Assessment 0 or 1.

“Both criteria are equivalent and show a ‘clear’ or ‘almost clear’ disease status and have traditionally been considered too stringent to define treatment response,” the authors wrote.

Only English and Spanish publications were included in the current review, marking a limitation. In addition, because treatment options for psoriasis continue to increase rapidly, validity of the results outlined could be limited in time, the researchers noted. No biosimilars were included in the studies.

Overall, “the appraised evidence illustrates significant heterogeneity in the criteria used to define anti–TNF-α failure,” the authors concluded.

“Although the recommendations on which treatment to choose after anti–TNF-α failure are scarce, our findings reflect a pattern in the last 10 years, with greater incorporation of new targets, mainly IL inhibitors such as IL-12/IL-23, IL-17, and IL-23 inhibitors in the treatment sequence for moderate to severe psoriasis patients,” they said.

Reference

Romero IB, Puchades AM, Pibernat MR, Genao DPR, de la Cueva Dobao P, Carrascosa JM. Criteria used to define tumor necrosis factor-alpha inhibitors failure in patients with moderate-to-severe psoriasis: a systematic literature review. Ann Med. Published online April 4, 2023. doi:10.1080/07853890.2023.2192957