A Study to Evaluate Further Therapeutic Strategies With Guselkumab in Participants With Moderate-to-Severe Plaque-Type Psoriasis
Summary
The purpose of this study is to demonstrate that Super-Responders (SRe; defined as psoriasis participants who receive on-label guselkumab treatment until week 20 and respond with a Psoriasis Area and Severity Index score (PASI) = 0 at weeks 20 and 28) maintain control of disease until week 68 with prolonged treatment intervals of 16 weeks (guselkumab 100 mg every 16 weeks).
Timeline
- Start
- 2019-02-08
- Primary completion
- 2022-03-07
- Completion
- 2025-01-07
Outcome
Met primary endpoint
paper The primary end point of noninferiority for guselkumab every 16 weeks vs every 8 weeks in SRes was met (P = .001), PMID 39083288 ↗
registry analysis (non-inferiority test); Part 2 Group 2a: Guselkumab 100 mg Q8W vs Part 2 Group 2b: Guselkumab 100 mg Q16W; p = 0.0013; Risk Difference (RD) -0.6 (90% CI -5.7 to 4.5); Wald Z-test NCT03818035 ↗
release “Schäkel K,et al. 16-week treatment interval of guselkumab is non-inferior to 8-week dosing for maintaining psoriasis control in super responders: GUIDE study primary result.” jnj.com ↗
Publications
- Eyerich K, Asadullah K, Pinter A, Weisenseel P, Reich K, Paul C, Sabat R, Wolk K, Eyerich S, Lauffer F, Angsana J, Taut FJH, Kohler K, Chen Y, Sendecki J, Leung MWL, Wegner S, Personke Y, Gomez M, Kruger N, Tabori S, Schakel K. Noninferiority of 16-Week vs 8-Week Guselkumab Dosing in Super Responders for Maintaining Control of Psoriasis: The GUIDE Randomized Clinical Trial. JAMA Dermatol. 2024 Sep 1;160(9):953-963. doi: 10.1001/jamadermatol.2024.2463.
- Eyerich K, Weisenseel P, Pinter A, Schakel K, Asadullah K, Wegner S, Munoz-Elias EJ, Bartz H, Taut FJH, Reich K. IL-23 blockade with guselkumab potentially modifies psoriasis pathogenesis: rationale and study protocol of a phase 3b, randomised, double-blind, multicentre study in participants with moderate-to-severe plaque-type psoriasis (GUIDE). BMJ Open. 2021 Sep 13;11(9):e049822. doi: 10.1136/bmjopen-2021-049822.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Guselkumab | Monoclonal antibody | 100 mg | Subcutaneous |