Tumor Necrosis Factor Inhibitor Monotherapy Versus Combination Therapy for the Treatment of Psoriatic Arthritis: Combined Analysis of European Biologics Databases

Thomas, Matthew L.; Shaddick, Gavin; Charlton, Rachel; Cavill, Charlotte; Holland, Richard; Iannone, Florenzo; Lapadula, Giovanni; Lopriore, Simona; Závada, Jakub; Uher, Μ.; Pavelka, Karel; Szczuková, Lenka; Sidiropoulos, Prodromos; Flouri, Irini; Drosos, Alexandros A.; Möller, Burkhard; Nissén, Michael John; Müller, Rüdiger; Scherer, Almut; McHugh, Neil

doi:10.3899/jrheum.190815

Cited by 10 publications

(9 citation statements)

References 34 publications

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“…Another recent register-based study (including data from three of the same registers, as the present study: Italy, Czech Republic and Switzerland) found no effect of comedication on treatment response. 22 However, in that study, all TNFi were analysed together. By contrast, the results of our stratified secondary analysis suggest that clear differences between the TNFi can explain some of this discrepancy and that combining the drug-specific effects may have diluted the overall effect observed in that study.…”

Section: Discussionmentioning

confidence: 98%

Effectiveness and treatment retention of TNF inhibitors when used as monotherapy versus comedication with csDMARDs in 15 332 patients with psoriatic arthritis. Data from the EuroSpA collaboration

Lindström

Giuseppe

Delcoigne

et al. 2021

Annals of the Rheumatic Diseases

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BackgroundComedication with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) during treatment with tumour necrosis factor inhibitors (TNFi) is extensively used in psoriatic arthritis (PsA), although the additive benefit remains unclear. We aimed to compare treatment outcomes in patients with PsA treated with TNFi and csDMARD comedication versus TNFi monotherapy.MethodsPatients with PsA from 13 European countries who initiated a first TNFi in 2006–2017 were included. Country-specific comparisons of 1 year TNFi retention were performed by csDMARD comedication status, together with HRs for TNFi discontinuation (comedication vs monotherapy), adjusted for age, sex, calendar year, disease duration and Disease Activity Score with 28 joints (DAS28). Adjusted ORs of clinical remission (based on DAS28) at 12 months were calculated. Between-country heterogeneity was assessed using random-effect meta-analyses, combined results were presented when heterogeneity was not significant. Secondary analyses stratified according to TNFi subtype (adalimumab/infliximab/etanercept) and restricted to methotrexate as comedication were performed.ResultsIn total, 15 332 patients were included (62% comedication, 38% monotherapy). TNFi retention varied across countries, with significant heterogeneity precluding a combined estimate. Comedication was associated with better remission rates, pooled OR 1.25 (1.12–1.41). Methotrexate comedication was associated with improved remission for adalimumab (OR 1.45 (1.23–1.72)) and infliximab (OR 1.55 (1.21–1.98)) and improved retention for infliximab. No effect of comedication was demonstrated for etanercept.ConclusionThis large observational study suggests that, as used in clinical practice, csDMARD and TNFi comedication are associated with improved remission rates, and specifically, comedication with methotrexate increases remission rates for both adalimumab and infliximab.

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Section: Discussionmentioning

confidence: 98%

Effectiveness and treatment retention of TNF inhibitors when used as monotherapy versus comedication with csDMARDs in 15 332 patients with psoriatic arthritis. Data from the EuroSpA collaboration

Lindström

Giuseppe

Delcoigne

et al. 2021

Annals of the Rheumatic Diseases

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“…In addition to the issue of multiplicity, our study has the limitation of not including other factors that in previous studies have been associated with b/tsDMARD persistence in patients with these conditions, such as smoking status, baseline comorbidity, global health, functional status, C-reactive protein or disease activity (5,18,19,24,25,30), although the role of these factors is not consistent across studies. Therefore, the presence of residual confounding could have biased our results.…”

Section: Discussionmentioning

confidence: 99%

“…The results from registries and other observational sources regarding the impact of combination therapy on drug persistence show inconsistent results. Some studies have shown no difference between combination therapy and monotherapy(18-21); others suggest that bDMARD persistence is better when adding a csDMARD (10,(22)(23)(24)(25).According to clinical practice guidelines, in adult patients with ankylosing spondylitis (AS), despite treatment with NSAIDs, treatment with a TNFi over no treatment with a TNFi is strongly recommended, but, although with a low level of evidence, the guidelines recommend against the coadministration of MTX(26). Information from registries or observational studies on biologic persistence in patients with AS is very limited and shows somewhat inconsistent results, but most studies show no impact of adding MTX to the TNFi (23,27, 28), while only one study indicates a higher persistence of the TNFi in those patients receiving concomitant MTX(10).…”

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confidence: 99%

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Real-life persistence of targeted therapy strategy in monotherapy versus combination therapy in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis

Expósito

Sánchez-Piedra

Vela‐Casasempere

et al. 2022

Preprint

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Aim: To evaluate the persistence of the initial strategy of targeted therapy, with or without conventional synthetic (cs) disease-modifying antirheumatic drugs (DMARDs) (combination and monotherapy strategies, respectively) in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS), under real-life conditions. Methods: This is a nested cohort study within BIOBADASER III, a prospective Spanish registry of patients with rheumatic diseases who are undergoing treatment with targeted therapy including biologics (b) and targeted synthetic (ts) DMARDs. The primary outcome was to determine the initial treatment strategy persistence; switching drugs within the same class, but maintaining the initial strategy (combination or monotherapy) was considered persistence. Bivariate comparisons and multivariate Cox proportional hazard models were used for the analyses.Results: A total of 2,589 patients were included in our study. In the multivariate model, compared to monotherapy, the combination therapy strategy was associated with shorter persistence in patients with RA (hazard ratio [HR] 1.58, 95% confidence interval [CI] 1.00 to 2.50, p=0.049), PsA-Axial (HR 3.00, 95% CI 1.35 to 6.70, p=0.007), PsA-Peripheral (HR 2.58, 95% CI 1.51 to 4.39, p<0.001) and AS (HR 16.77, 95% CI 7.37 to 38.16, p<0.001). Overall, the combination strategy was associated with an increased incidence of any adverse event (incidence rate ratio [IRR] 1.13, 95% CI 1.05-1.21) but not of serious adverse events (1.02, 95% CI 0.84-1.24) compared to monotherapy,Conclusion: In this real-life study, compared to monotherapy, the strategy of combining a b/tsDMARD with a csDMARD at the start of treatment is associated with lower persistence and worse tolerability in RA, PsA and especially in AS, suggesting that combination therapy should be avoided in AS and possibly PsA patients and used cautiously in RA patients.

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“…Some studies have shown no difference between combination therapy and monotherapy [17][18][19][20] ; others suggest that bDMARD persistence is better when adding a csDMARD. 9,[21][22][23][24] According to clinical practice guidelines, in adult patients with ankylosing spondylitis (AS), despite treatment with NSAIDs, treatment with a TNFi over no treatment with a TNFi is strongly recommended, but, although with a low level of evidence, the guidelines recommend against the coadministration of MTX. 25 Information from registries or observational studies on biologic persistence in patients with AS is very limited and shows somewhat inconsistent results, but most studies show no impact of adding MTX to the TNFi, 22,26,27 while only one study indicates a higher persistence of the TNFi in those patients receiving concomitant MTX.…”

Section: Introductionmentioning

confidence: 99%

Real‐world persistence of initial targeted therapy strategy in monotherapy versus combination therapy in patients with chronic inflammatory arthritis

Exposito,

Sánchez‐Piedra,

Vela‐Casasempere

et al. 2023

Eur J Clin Investigation

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ObjectiveThe persistence of biologic (b) and targeted synthetic (ts) disease‐modifying antirheumatic drugs(DMARDs) in monotherapy versus in combination with conventional synthetic (cs) DMARDs is still a controversial topic in rheumatic diseases. To clarify this issue, the retention of the initial treatment strategy of b/tsDMARD in combination with csDMARD versus monotherapy in rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) patients under real‐life conditions was evaluated. Factors associated with maintenance of the initial strategy were analysed.MethodsNested cohort study within the Spanish BIOBADASER III registry. Bivariate comparisons and multivariate Cox proportional hazards models were used for the analyses.ResultsA total of 2521 patients were included in the study. In the multivariate model, the initial strategy of combination therapy was associated with shorter persistence in patients with RA (hazard ratio [HR] 1.58;95% confidence interval [CI] 1.00–2.50; p = .049), PsA (HR 2.48; 95% CI 1.65–3.72) and AS (HR 16.77; 95% CI 7.37–38.16; p < .001), regardless of sex, time of disease progression, baseline disease activity, glucocorticoid use or type of b/tsDMARD. Overall, the combination strategy was associated with an increased incidence of adverse events (incidence rate ratio [IRR] 1.13; 95% CI 1.05–1.21).ConclusionsIn this real‐life study, the strategy of combining a b/tsDMARD with a csDMARD is associated with lower persistence and worse safety profile compared to monotherapy in RA and especially in PsA and AS, suggesting that combination therapy should be rethought as first choice in RA patients, but especially in PsA and AS patients.

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Tumor Necrosis Factor Inhibitor Monotherapy Versus Combination Therapy for the Treatment of Psoriatic Arthritis: Combined Analysis of European Biologics Databases

Cited by 10 publications

References 34 publications

Effectiveness and treatment retention of TNF inhibitors when used as monotherapy versus comedication with csDMARDs in 15 332 patients with psoriatic arthritis. Data from the EuroSpA collaboration

Effectiveness and treatment retention of TNF inhibitors when used as monotherapy versus comedication with csDMARDs in 15 332 patients with psoriatic arthritis. Data from the EuroSpA collaboration

Real-life persistence of targeted therapy strategy in monotherapy versus combination therapy in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis

Real‐world persistence of initial targeted therapy strategy in monotherapy versus combination therapy in patients with chronic inflammatory arthritis

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