Real-Life Evaluation of Guselkumab Dosing Interval Adjustments

NCT07430319 | Recruiting

• 1 other identifier: 26Dermato01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

"Guselkumab (Tremfya®) is a fully human monoclonal antibody that selectively targets interleukin-23 (IL-23), a key cytokine involved in the inflammatory pathways of psoriasis. This biologic therapy received marketing authorization in France in 2018 for the treatment of moderate-to-severe plaque psoriasis in adults requiring systemic therapy. This indication includes patients with extensive disease, with or without significant psychosocial impact, and those who have had an inadequate response, contraindication, or intolerance to at least two conventional systemic non-biologic treatments (such as methotrexate, ciclosporin, or acitretin) or phototherapy. The GUIDE study demonstrated that guselkumab injection intervals may be extended in psoriasis "super-responders" (defined as PASI 0 at Weeks 20 and 28). In this study, dosing intervals were extended from 8 to 16 weeks starting at Week 28 without waiting for prolonged confirmation of complete response. While the primary endpoint (maintenance of PASI \<3 at Week 64) showed non-inferiority between the q8 and q16 groups, patients receiving injections every 16 weeks experienced a significantly greater loss of PASI 0 and PASI 1 responses at Week 64. This was associated with a reduction in quality of life (measured by DLQI) in the 16-week group compared with the 8-week group. Nevertheless, GUIDE highlights the flexibility of guselkumab administration, particularly in super-responders at Week 28. Guselkumab (Tremfya®) is a biologic treatment used for moderate to severe psoriasis. It works by blocking a molecule involved in inflammation and has been approved in France since 2018. The standard dosing schedule is one injection every 8 weeks after the initial treatment phase. A clinical study (GUIDE) showed that in some patients who respond extremely well to treatment ("super responders"), it may be possible to space the injections further apart. However, extending injections to every 16 weeks slightly reduced the chance of maintaining complete skin clearance in some patients. In real-life practice, many dermatology centers gradually increase the time between injections once patients achieve stable and almost complete clearance of their psoriasis. The approach varies between centers. Using large French healthcare databases, we studied how guselkumab is used in routine practice. We found that about 38% of patients spaced their injections beyond the recommended 8 weeks, and this proportion increased to 47% in patients treated for more than 2 years. Importantly, spacing injections did not reduce how long patients stayed on treatment. Among patients who stopped guselkumab after spacing their doses, most did not need another systemic treatment for at least one year, suggesting that some patients may benefit from temporary "treatment breaks." These results suggest that for certain patients with well-controlled psoriasis, guselkumab dosing may be safely adjusted, offering greater flexibility, reduced treatment burden, and potentially lower healthcare costs."

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (3)

• Evaluation of the modalities of guselkumab dose spacing

  PASI Score ( Psoriasis Area and Severity Index )

  At the inclusion

• Psoriasis severity

  PASI Score ( Psoriasis Area and Severity Index )

  At the inclusion

• Duration of guselkumab treatment prior to dose spacing

  In weeks

  At the inclusion

Secondary Outcomes (2)

• Evaluation of patient characteristics in individuals undergoing Dose spacing

  At the inclusion

• Evaluation of Guselkumab Treatment Persistence During Dose Spacing

  At the inclusion

Study Arms (1)

Patients diagnosed with cutaneous psoriasis

Treated with guselkumab for whom dose spacing has been proposed.

Drug: Guselkumab (Tremfya®)

Interventions

Guselkumab (Tremfya®) DRUG

Guselkumab (Tremfya®) is a fully human monoclonal antibody that selectively targets the p19 subunit of interleukin-23 (IL-23), a key cytokine involved in the inflammatory pathway of psoriasis. By inhibiting IL-23, guselkumab reduces downstream inflammatory signaling and improves psoriatic skin lesions. The aprouved dosing regimen: * 100 mg administered by subcutaneous injection at Week 0 and Week 4 (induction phase), * followed by 100 mg every 8 weeks thereafter (maintenance phase).

Patients diagnosed with cutaneous psoriasis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Eligible patients diagnosed with cutaneous psoriasis treated with guselkumab, for whom a dosing interval extension was proposed

You may qualify if:

• Adult patients receiving guselkumab for cutaneous psoriasis. 2.
• Guselkumab treatment with dosing intervals exceeding 9 weeks.

You may not qualify if:

• Patients receiving guselkumab primarily for joint involvement.
• Patients for whom guselkumab dosing was extended due to surgery, pregnancy, or infection.
• Patients for whom the PASI or IGA score was not assessed during visits

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, Alpes Maritimes, 06000, France

RECRUITING

MeSH Terms

Conditions

Psoriasis

Interventions

guselkumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Thierry PASSERON

CONTACT

0492036225; passeron.t@chu-nice.fr

Ruxanda MOSCHOI

CONTACT

0492033993; moschoi.r@chu-nice.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: February 24, 2026
• Study Start: October 16, 2025
• Primary Completion: April 16, 2026
• Study Completion: April 16, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

FR (1)