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P180 Long-term follow-up of patients in the golimumab and methotrexate versus placebo and methotrexate in early, untreated psoriatic arthritis trial
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Abstract
Background/Aims
The GOLMePsA strategy trial showed that early combination therapy with golimumab, methotrexate (GOLMTX), and corticosteroids was not superior to methotrexate (PBOMTX) and corticosteroids alone in reducing disease activity at 24 weeks in treatment-naïve psoriatic arthritis (PsA). Here, we aimed to assess long-term treatment patterns several years after trial completion.
Methods
We conducted a retrospective case note review of participants who completed the GOLMePsA study and continued follow up at the Leeds Specialist Spondyloarthritis Service (Leeds, UK). Data were extracted from electronic health records, including last study visit date, most recent clinical visit date, clinical and laboratory data at follow up, current and historical PsA treatments. No imaging reassessment was performed, and disease activity measures were not routinely recorded. Analyses were descriptive.
Results
Of 84 study participants, data were available for 79 attending our outpatient service (GOLMTX arm=38/43, PBOMTX arm=41/41) with a median follow-up since trial completion of 4.4 (2.7-6.3 IQR) years. Patterns of therapy were comparable across the two original arms with 54% of patients receiving a biological disease modifying anti-rheumatic drug (bDMARD) (58% in GOLMTX, 51% in PBOMTX arm) at follow up (3% in GOLMTX and 5% in PBOMTX arm at the end of the study). Methotrexate use was similar between groups but overall reduced (42% in GOLMTX and 54% in PBOMTX arm) when compared to the end of the study (92% and 88% respectively). Looking at the total DMARD exposure since the end of the trial, most patients had received ≤2 conventional synthetic DMARDs (95%); 39% had received one bDMARD and 43% had received no bDMARDs. These patterns of therapy were similar across the two original trial arms.
Conclusion
Four year follow up of this cohort confirms similar bDMARD uptake irrespective of initial treatment allocation, in half the population. Of note, although numbers are small, the limited sequencing of bDMARDs seen over time suggests the enhanced benefits of early intervention in PsA. Eventual translation into a reduced rate of difficult to manage or treatment resistant disease can only be confirmed with longer follow up of this and similar, larger cohorts.
Disclosure
K. Meridor: Consultancies; KM received consultancy fees from AbbVie. R. Granados: None. S.R. Harrison: Other; SRH received speaker fees for a non-promotional educational talk from Janssen, UCB and Novartis. She has received support to attend conferences from UCB and Janssen. P.S. Helliwell: Consultancies; PSH received speaker fees from Janssen and Novartis, received consultancy fees from Amgen. D. McGonagle: Grants/research support; DMG received speaker fees from Abbvie, BMS, Celegene, Janssen, Lilly, Novartis, Moonlake, Pfizer and UCB, received grant funding from Abbvie, BMS, Celegene, Janssen, Lilly, Novartis, Moonlake, Pfizer. G. De Marco: Consultancies; GDM received consultancy fees from Johnson&Johnson, Novartis and speaker’s fees from Johnson&Johnson, Novartis and UCB. H. Marzo-Ortega: Grants/research support; HM-O received research grants from Janssen, Novartis, Pfizer, and UCB; and honoraria/speaker fees from AbbVie, Amgen, Biogen, Eli Lilly, Janssen, Moonlake, Novartis, Pfizer, Takeda, and UCB.
Oxford University Press (OUP)
Title: P180 Long-term follow-up of patients in the golimumab and methotrexate versus placebo and methotrexate in early, untreated psoriatic arthritis trial
Description:
Abstract
Background/Aims
The GOLMePsA strategy trial showed that early combination therapy with golimumab, methotrexate (GOLMTX), and corticosteroids was not superior to methotrexate (PBOMTX) and corticosteroids alone in reducing disease activity at 24 weeks in treatment-naïve psoriatic arthritis (PsA).
Here, we aimed to assess long-term treatment patterns several years after trial completion.
Methods
We conducted a retrospective case note review of participants who completed the GOLMePsA study and continued follow up at the Leeds Specialist Spondyloarthritis Service (Leeds, UK).
Data were extracted from electronic health records, including last study visit date, most recent clinical visit date, clinical and laboratory data at follow up, current and historical PsA treatments.
No imaging reassessment was performed, and disease activity measures were not routinely recorded.
Analyses were descriptive.
Results
Of 84 study participants, data were available for 79 attending our outpatient service (GOLMTX arm=38/43, PBOMTX arm=41/41) with a median follow-up since trial completion of 4.
4 (2.
7-6.
3 IQR) years.
Patterns of therapy were comparable across the two original arms with 54% of patients receiving a biological disease modifying anti-rheumatic drug (bDMARD) (58% in GOLMTX, 51% in PBOMTX arm) at follow up (3% in GOLMTX and 5% in PBOMTX arm at the end of the study).
Methotrexate use was similar between groups but overall reduced (42% in GOLMTX and 54% in PBOMTX arm) when compared to the end of the study (92% and 88% respectively).
Looking at the total DMARD exposure since the end of the trial, most patients had received ≤2 conventional synthetic DMARDs (95%); 39% had received one bDMARD and 43% had received no bDMARDs.
These patterns of therapy were similar across the two original trial arms.
Conclusion
Four year follow up of this cohort confirms similar bDMARD uptake irrespective of initial treatment allocation, in half the population.
Of note, although numbers are small, the limited sequencing of bDMARDs seen over time suggests the enhanced benefits of early intervention in PsA.
Eventual translation into a reduced rate of difficult to manage or treatment resistant disease can only be confirmed with longer follow up of this and similar, larger cohorts.
Disclosure
K.
Meridor: Consultancies; KM received consultancy fees from AbbVie.
R.
Granados: None.
S.
R.
Harrison: Other; SRH received speaker fees for a non-promotional educational talk from Janssen, UCB and Novartis.
She has received support to attend conferences from UCB and Janssen.
P.
S.
Helliwell: Consultancies; PSH received speaker fees from Janssen and Novartis, received consultancy fees from Amgen.
D.
McGonagle: Grants/research support; DMG received speaker fees from Abbvie, BMS, Celegene, Janssen, Lilly, Novartis, Moonlake, Pfizer and UCB, received grant funding from Abbvie, BMS, Celegene, Janssen, Lilly, Novartis, Moonlake, Pfizer.
G.
De Marco: Consultancies; GDM received consultancy fees from Johnson&Johnson, Novartis and speaker’s fees from Johnson&Johnson, Novartis and UCB.
H.
Marzo-Ortega: Grants/research support; HM-O received research grants from Janssen, Novartis, Pfizer, and UCB; and honoraria/speaker fees from AbbVie, Amgen, Biogen, Eli Lilly, Janssen, Moonlake, Novartis, Pfizer, Takeda, and UCB.
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