Guselkumab provides durable improvement across psoriatic arthritis disease domains: post hoc analysis of a phase 3, randomised, double-blind, placebo-controlled study
Objective Evaluate long-term guselkumab effectiveness across Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)-recognised domains/related conditions of psoriatic arthritis (PsA).Methods Post hoc analyses used data from DISCOVER-2 (NCT03158285) biologic/Janus-kinase inhi...
| Main Authors: | , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2024-03-01
|
| Series: | RMD Open |
| Online Access: | https://rmdopen.bmj.com/content/10/1/e003977.full |
| _version_ | 1797224777215115264 |
|---|---|
| author | Laure Gossec Peter Nash Philip J Mease Emmanouil Rampakakis Laura C Coates Philip S Helliwell Alexa P Kollmeier Xie L Xu May Shawi Miriam Zimmermann Natalie J Shiff |
| author_facet | Laure Gossec Peter Nash Philip J Mease Emmanouil Rampakakis Laura C Coates Philip S Helliwell Alexa P Kollmeier Xie L Xu May Shawi Miriam Zimmermann Natalie J Shiff |
| author_sort | Laure Gossec |
| collection | DOAJ |
| description | Objective Evaluate long-term guselkumab effectiveness across Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)-recognised domains/related conditions of psoriatic arthritis (PsA).Methods Post hoc analyses used data from DISCOVER-2 (NCT03158285) biologic/Janus-kinase inhibitor-naïve participants with active PsA (≥5 swollen/≥5 tender joints, C-reactive protein ≥0.6 mg/dL), randomised (1:1:1) to guselkumab every 4 or 8 weeks (Q4W/Q8W) or placebo with crossover to guselkumab. Outcomes aligned with key GRAPPA-recognised domains of overall disease activity, peripheral arthritis, axial disease, enthesitis/dactylitis and skin psoriasis (nail psoriasis was not evaluated). PsA-related conditions (inflammatory bowel disease (IBD)/uveitis) were assessed via adverse events through W112. Least squares mean changes from baseline through W100 in continuous outcomes employed repeated measures mixed-effects models adjusting for baseline scores. Binary measure response rates were determined with non-responder imputation for missing data.Results 442/493 (90%) of guselkumab-randomised patients completed treatment through W100. Following early reductions in disease activity with guselkumab, durable improvements were observed across key PsA domains (swollen/tender joints, psoriasis, spinal pain, enthesitis/dactylitis) through W100. Response rates of therapeutically relevant targets generally increased through W100 with guselkumab Q4W/Q8W: Disease Activity Index for PsA low disease activity (LDA) 62%/59%, enthesitis resolution 61%/70%, dactylitis resolution 72%/83%, 100% improvement in Psoriasis Area and Severity Index 59%/53%, Psoriatic Arthritis Disease Activity Score LDA 51%/49% and minimal disease activity 38%/40%. Through W112, no cases of IBD developed among guselkumab-randomised patients and one case of uveitis was reported.Conclusion In biologic-naïve patients with active PsA, guselkumab provided early and durable improvements in key GRAPPA-recognised domains through 2 years, with substantial proportions achieving important treatment targets. |
| first_indexed | 2024-04-24T13:58:30Z |
| format | Article |
| id | doaj.art-01b673a8b5db409dbf5ca6cc6e25b045 |
| institution | Directory Open Access Journal |
| issn | 2056-5933 |
| language | English |
| last_indexed | 2024-04-24T13:58:30Z |
| publishDate | 2024-03-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | RMD Open |
| spelling | doaj.art-01b673a8b5db409dbf5ca6cc6e25b0452024-04-03T13:30:09ZengBMJ Publishing GroupRMD Open2056-59332024-03-0110110.1136/rmdopen-2023-003977Guselkumab provides durable improvement across psoriatic arthritis disease domains: post hoc analysis of a phase 3, randomised, double-blind, placebo-controlled studyLaure Gossec0Peter Nash1Philip J Mease2Emmanouil Rampakakis3Laura C Coates4Philip S Helliwell5Alexa P Kollmeier6Xie L Xu7May Shawi8Miriam Zimmermann9Natalie J Shiff10INSERM, Institut Pierre Louis d`Epidémiologie et de Santé Publique, Sorbonne Universite, Paris, FranceSchool of Medicine, Griffith University, Brisbane, Queensland, AustraliaUniversity of Washington, Seattle, Washington, USAMcGill University Health Centre, Montreal, Quebec, CanadaNuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UKsenior lecturerImmunology, Janssen Research & Development, San Diego, California, USAImmunology, Janssen Research & Development, San Diego, California, USAImmunology Medical Affairs, Janssen Global Services LLC, Horsham, Pennsylvania, USAEMEA Medical Affairs Immunology, Janssen-Cilag, Zug, SwitzerlandDepartment of Community Health & Epidemiology, University of Saskatchewan, Saskatoon, Saskatchewan, CanadaObjective Evaluate long-term guselkumab effectiveness across Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)-recognised domains/related conditions of psoriatic arthritis (PsA).Methods Post hoc analyses used data from DISCOVER-2 (NCT03158285) biologic/Janus-kinase inhibitor-naïve participants with active PsA (≥5 swollen/≥5 tender joints, C-reactive protein ≥0.6 mg/dL), randomised (1:1:1) to guselkumab every 4 or 8 weeks (Q4W/Q8W) or placebo with crossover to guselkumab. Outcomes aligned with key GRAPPA-recognised domains of overall disease activity, peripheral arthritis, axial disease, enthesitis/dactylitis and skin psoriasis (nail psoriasis was not evaluated). PsA-related conditions (inflammatory bowel disease (IBD)/uveitis) were assessed via adverse events through W112. Least squares mean changes from baseline through W100 in continuous outcomes employed repeated measures mixed-effects models adjusting for baseline scores. Binary measure response rates were determined with non-responder imputation for missing data.Results 442/493 (90%) of guselkumab-randomised patients completed treatment through W100. Following early reductions in disease activity with guselkumab, durable improvements were observed across key PsA domains (swollen/tender joints, psoriasis, spinal pain, enthesitis/dactylitis) through W100. Response rates of therapeutically relevant targets generally increased through W100 with guselkumab Q4W/Q8W: Disease Activity Index for PsA low disease activity (LDA) 62%/59%, enthesitis resolution 61%/70%, dactylitis resolution 72%/83%, 100% improvement in Psoriasis Area and Severity Index 59%/53%, Psoriatic Arthritis Disease Activity Score LDA 51%/49% and minimal disease activity 38%/40%. Through W112, no cases of IBD developed among guselkumab-randomised patients and one case of uveitis was reported.Conclusion In biologic-naïve patients with active PsA, guselkumab provided early and durable improvements in key GRAPPA-recognised domains through 2 years, with substantial proportions achieving important treatment targets.https://rmdopen.bmj.com/content/10/1/e003977.full |
| spellingShingle | Laure Gossec Peter Nash Philip J Mease Emmanouil Rampakakis Laura C Coates Philip S Helliwell Alexa P Kollmeier Xie L Xu May Shawi Miriam Zimmermann Natalie J Shiff Guselkumab provides durable improvement across psoriatic arthritis disease domains: post hoc analysis of a phase 3, randomised, double-blind, placebo-controlled study RMD Open |
| title | Guselkumab provides durable improvement across psoriatic arthritis disease domains: post hoc analysis of a phase 3, randomised, double-blind, placebo-controlled study |
| title_full | Guselkumab provides durable improvement across psoriatic arthritis disease domains: post hoc analysis of a phase 3, randomised, double-blind, placebo-controlled study |
| title_fullStr | Guselkumab provides durable improvement across psoriatic arthritis disease domains: post hoc analysis of a phase 3, randomised, double-blind, placebo-controlled study |
| title_full_unstemmed | Guselkumab provides durable improvement across psoriatic arthritis disease domains: post hoc analysis of a phase 3, randomised, double-blind, placebo-controlled study |
| title_short | Guselkumab provides durable improvement across psoriatic arthritis disease domains: post hoc analysis of a phase 3, randomised, double-blind, placebo-controlled study |
| title_sort | guselkumab provides durable improvement across psoriatic arthritis disease domains post hoc analysis of a phase 3 randomised double blind placebo controlled study |
| url | https://rmdopen.bmj.com/content/10/1/e003977.full |
| work_keys_str_mv | AT lauregossec guselkumabprovidesdurableimprovementacrosspsoriaticarthritisdiseasedomainsposthocanalysisofaphase3randomiseddoubleblindplacebocontrolledstudy AT peternash guselkumabprovidesdurableimprovementacrosspsoriaticarthritisdiseasedomainsposthocanalysisofaphase3randomiseddoubleblindplacebocontrolledstudy AT philipjmease guselkumabprovidesdurableimprovementacrosspsoriaticarthritisdiseasedomainsposthocanalysisofaphase3randomiseddoubleblindplacebocontrolledstudy AT emmanouilrampakakis guselkumabprovidesdurableimprovementacrosspsoriaticarthritisdiseasedomainsposthocanalysisofaphase3randomiseddoubleblindplacebocontrolledstudy AT lauraccoates guselkumabprovidesdurableimprovementacrosspsoriaticarthritisdiseasedomainsposthocanalysisofaphase3randomiseddoubleblindplacebocontrolledstudy AT philipshelliwell guselkumabprovidesdurableimprovementacrosspsoriaticarthritisdiseasedomainsposthocanalysisofaphase3randomiseddoubleblindplacebocontrolledstudy AT alexapkollmeier guselkumabprovidesdurableimprovementacrosspsoriaticarthritisdiseasedomainsposthocanalysisofaphase3randomiseddoubleblindplacebocontrolledstudy AT xielxu guselkumabprovidesdurableimprovementacrosspsoriaticarthritisdiseasedomainsposthocanalysisofaphase3randomiseddoubleblindplacebocontrolledstudy AT mayshawi guselkumabprovidesdurableimprovementacrosspsoriaticarthritisdiseasedomainsposthocanalysisofaphase3randomiseddoubleblindplacebocontrolledstudy AT miriamzimmermann guselkumabprovidesdurableimprovementacrosspsoriaticarthritisdiseasedomainsposthocanalysisofaphase3randomiseddoubleblindplacebocontrolledstudy AT nataliejshiff guselkumabprovidesdurableimprovementacrosspsoriaticarthritisdiseasedomainsposthocanalysisofaphase3randomiseddoubleblindplacebocontrolledstudy |