P258 Secukinumab Improves Physical Function and Inhibits Structural Damage in Psoriatic Arthritis PsA Patients With Sustained Remission or Low Disease Activity: Results From a Phase 3 Study. (23rd April 2022)
- Record Type:
- Journal Article
- Title:
- P258 Secukinumab Improves Physical Function and Inhibits Structural Damage in Psoriatic Arthritis PsA Patients With Sustained Remission or Low Disease Activity: Results From a Phase 3 Study. (23rd April 2022)
- Main Title:
- P258 Secukinumab Improves Physical Function and Inhibits Structural Damage in Psoriatic Arthritis PsA Patients With Sustained Remission or Low Disease Activity: Results From a Phase 3 Study
- Authors:
- Coates, Laura C
Mease, Philip J
Gladman, Dafna D
Navarra, Sandra
Bao, Weibin
Gaillez, Corine - Abstract:
- Abstract: Background/Aims: Disease Activity Index for Psoriatic Arthritis (DAPSA) or the minimal disease activity (MDA) are considered for defining remission (REM) or low disease activity (LDA) in secukinumab-treated patients with psoriatic arthritis (PsA). Currently, limited secukinumab data are available on patients with PsA achieving sustained REM in clinical trials or real-world evidence using these stringent criteria. This abstract reports an exploratory analysis of achievement of sustained REM/LDA in patients with PsA treated with secukinumab and impact on structural outcomes, physical function and health-related quality of life (HRQoL) in the FUTURE 5 study (NCT02404350). Methods: FUTURE 5 is a randomised, double-blind, placebo-controlled, 2-year phase 3 trial in patients with active PsA. Patients randomised to secukinumab 150 mg could be escalated to 300 mg from week 52 to 104, based on investigators' judgement. Patients were categorised as either not achieving REM/LDA, achieving it once only, or sustained REM/LDA (defined as patients achieving REM/LDA between weeks 24-52 and maintaining the same response at least 2 of the next 6 visits [visit every 8 weeks]). Of patients who did not achieve REM/LDA or who achieved REM/LDA (VLDA, DAPSA REM, MDA, DAPSA LDA+REM) between weeks 24 and 52, the relationships between: absence of REM/LDA; REM/LDA; sustained REM/LDA; proportion of patients with non-radiographic progression (assessed using the van der Heijde [mTSS]); physicalAbstract: Background/Aims: Disease Activity Index for Psoriatic Arthritis (DAPSA) or the minimal disease activity (MDA) are considered for defining remission (REM) or low disease activity (LDA) in secukinumab-treated patients with psoriatic arthritis (PsA). Currently, limited secukinumab data are available on patients with PsA achieving sustained REM in clinical trials or real-world evidence using these stringent criteria. This abstract reports an exploratory analysis of achievement of sustained REM/LDA in patients with PsA treated with secukinumab and impact on structural outcomes, physical function and health-related quality of life (HRQoL) in the FUTURE 5 study (NCT02404350). Methods: FUTURE 5 is a randomised, double-blind, placebo-controlled, 2-year phase 3 trial in patients with active PsA. Patients randomised to secukinumab 150 mg could be escalated to 300 mg from week 52 to 104, based on investigators' judgement. Patients were categorised as either not achieving REM/LDA, achieving it once only, or sustained REM/LDA (defined as patients achieving REM/LDA between weeks 24-52 and maintaining the same response at least 2 of the next 6 visits [visit every 8 weeks]). Of patients who did not achieve REM/LDA or who achieved REM/LDA (VLDA, DAPSA REM, MDA, DAPSA LDA+REM) between weeks 24 and 52, the relationships between: absence of REM/LDA; REM/LDA; sustained REM/LDA; proportion of patients with non-radiographic progression (assessed using the van der Heijde [mTSS]); physical function (health assessment questionnaire disability index [HAQ-DI]); and short form-36 physical component score [SF-36 PCS]) were assessed. Results: 996 patients were randomised to 1 of 4 treatment groups: secukinumab 300 mg loading dose (LD; n = 222), secukinumab 150 mg LD (n = 220), secukinumab 150 mg no LD (NL; n = 222), and placebo (n = 332). The baseline clinical characteristics were comparable across treatment groups. Most patients achieved either sustained MDA or sustained DAPSA LDA+REM (Table). Patients achieving REM/LDA, whether at one visit or consistently, showed improved physical function and SF36-PCS at week 104. A high proportion of patients did not show radiographic progression at week 104 irrespective of achievement of REM/LDA category. Conclusion: Most patients treated with secukinumab achieved a sustained LDA. Sustained LDA/REM was associated with improved HRQoL, physical function and inhibition of structural damage progression. Disclosure: L.C. Coates: Consultancies; Abbvie, Amgen, Biogen, Boehringer Ingelheim, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, UCB. Grants/research support; Abbvie, Celgene, Lilly, Novartis, Pfizer. P.J. Mease: Consultancies; AbbVie, Amgen, BMS, Boehringer Ingelheim, Galapagos, Celgene, GlaxoSmithKline, Gilead, Janssen, Lilly, Novartis, Pfizer, SUN Pharma, UCB. Member of speakers' bureau; AbbVie, Amgen, Janssen, Lilly, Novartis, Pfizer, UCB. Grants/research support; AbbVie, Amgen, BMS, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, SUN, UCB. D.D. Gladman: Consultancies; Abbvie, Amgen, BMS, Celgene, Eli Lilly, Gilead, Galapagos, Janssen, Novartis, Pfizer, UCB. Grants/research support; Abbvie, Amgen, Celgene, Eli Lilly, Novartis, Pfizer, UCB. S. Navarra: Consultancies; Pfizer, Novartis, Astra-Zeneca, Janssen, Lilly, Astellas. Member of speakers' bureau; Pfizer, Novartis, Astra-Zeneca, Janssen, Lilly, Astellas. W. Bao: Shareholder/stock ownership; Novartis. Other; Employee of Novartis. C. Gaillez: Shareholder/stock ownership; Novartis, BMS. Other; Employee of Novartis. … (more)
- Is Part Of:
- Rheumatology. Volume 61(2022)Supplement 1
- Journal:
- Rheumatology
- Issue:
- Volume 61(2022)Supplement 1
- Issue Display:
- Volume 61, Issue 1 (2022)
- Year:
- 2022
- Volume:
- 61
- Issue:
- 1
- Issue Sort Value:
- 2022-0061-0001-0000
- Page Start:
- Page End:
- Publication Date:
- 2022-04-23
- Subjects:
- Rheumatism -- Periodicals
Rheumatology -- Periodicals
616.723005 - Journal URLs:
- http://rheumatology.oupjournals.org ↗
http://rheumatology.oxfordjournals.org ↗
http://ukcatalogue.oup.com/ ↗
http://firstsearch.oclc.org ↗ - DOI:
- 10.1093/rheumatology/keac133.257 ↗
- Languages:
- English
- ISSNs:
- 1462-0324
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