The dynamics of response as measured by multiple composite outcome tools in the TIght COntrol of inflammation in early Psoriatic Arthritis (TICOPA) trial

Coates, Laura C.; Mahmood, Farrouq; Emery, Paul; Conaghan, Philip G.; Helliwell, Philip S.

doi:10.1136/annrheumdis-2017-211137

Cited by 21 publications

(13 citation statements)

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“…PASDAS baseline scores in OPAL Broaden were comparable with values reported in an equivalent study population [ 3 ]; however, along with the PASDAS baseline scores in OPAL Beyond, they were somewhat higher than those reported in a study of standard care [ 21 ] and patients in clinical practice [ 22 ]. In the GRACE (GRAPPA Composite Exercise) study, designed to develop composite disease activity and responder measures for PsA, a mean score of 5.30 for PASDAS was reported for patients changing treatment and this was taken as a surrogate for high disease activity [ 11 ].…”

Section: Discussionsupporting

confidence: 68%

Disease-specific composite measures for psoriatic arthritis are highly responsive to a Janus kinase inhibitor treatment that targets multiple domains of disease

et al. 2018

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BackgroundThe multiple disease domains affected in psoriatic arthritis (PsA) may make composite endpoints appropriate for assessing changes in disease activity over time. Tofacitinib is an oral Janus kinase inhibitor for the treatment of PsA. Data from two phase 3 studies of patients with PsA were used to evaluate the effect of tofacitinib on composite endpoints.MethodsOral Psoriatic Arthritis triaL (OPAL) Broaden was a 12-month study of tumor necrosis factor inhibitor (TNFi)-naïve patients with an inadequate response to at least one conventional synthetic disease-modifying anti-rheumatic drug; OPAL Beyond was a 6-month study of patients with inadequate response to TNFi. Patients with active PsA received tofacitinib 5 or 10 mg doses twice daily (BID), adalimumab 40 mg subcutaneous injection once every 2 weeks (OPAL Broaden only), or placebo advancing at month 3 to tofacitinib 5 or 10 mg BID. The disease-specific composites were Psoriatic Arthritis Disease Activity Score (PASDAS), Disease Activity Index for Reactive Arthritis/Psoriatic Arthritis (DAPSA), and Composite Psoriatic Disease Activity Index (CPDAI). Change from baseline in composite endpoints was also assessed for minimal disease activity (MDA) responders versus non-responders.ResultsOverall, 422 patients from OPAL Broaden and 394 patients from OPAL Beyond were treated. The mean changes from baseline to month 3 for tofacitinib 5 mg BID, tofacitinib 10 mg BID (standard error; effect size) were OPAL Broaden: PASDAS, −2.0 (0.14; 1.73), −2.4 (0.14; 2.4); DAPSA, −20.2 (1.72; 0.9), −24.4 (1.73; 1.23); and CPDAI, −2.9 (0.34; 1.03), −4.2 (0.36; 1.53); OPAL Beyond: PASDAS, −1.9 (0.14; 1.53), −2.1 (0.14; 1.84); DAPSA, −22.5 (1.67; 0.81), −21.0 (1.70; 0.84); and CPDAI, −3.3 (0.31; 1.41), −3.4 (0.31; 1.45). Greater changes from baseline to month 3 (P ≤0.05) were seen with both doses of tofacitinib versus placebo for all endpoints except CPDAI for tofacitinib 5 mg BID in OPAL Broaden. Effect sizes generally increased from 3 to 6 months. Mean changes from baseline were greater in MDA responders than MDA non-responders for all composite endpoints across all time points and treatments.ConclusionsThis analysis suggests that disease-specific composite measures are appropriate for evaluating treatment efficacy on multiple disease domains in PsA.Trial registrationOPAL Broaden: ClinicalTrials.gov Identifier: NCT01877668, first posted June 12, 2013; OPAL Beyond: ClinicalTrials.gov Identifier: NCT01882439, first posted June 20, 2013.Electronic supplementary materialThe online version of this article (10.1186/s13075-018-1739-0) contains supplementary material, which is available to authorized users.

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Section: Discussionsupporting

confidence: 68%

Disease-specific composite measures for psoriatic arthritis are highly responsive to a Janus kinase inhibitor treatment that targets multiple domains of disease

et al. 2018

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“…Full data to calculate the composite PsA disease activity index (CPDAI) were not available and so this definition was not included. In the both datasets, the PASDAS was calculated using an imputed measure as SF36 was not collected in the trial (6). Proportions achieving each criteria were calculated.…”

Section: Methodsmentioning

confidence: 99%

075. what Should Be the Primary Target of Treat to Target in Psoriatic Arthritis?

et al. 2017

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Background: Treat to Target in psoriatic arthritis (PsA) recommendations have stated that the target should be remission or inactive disease. Potential definitions include Very Low Disease Activity (VLDA), PsA Disease Activity Score (PASDAS) near remission, Disease Activity in PsA (DAPSA) or clinical DAPSA remission. Our aim was to investigate the proportion of patients who fulfil these definitions and how much residual active disease remained. Methods: This analysis used two datasets: firstly, trial data from the Tight Control of PsA (TICOPA) study which included 206 patients with recent onset (<2 years) PsA receiving standard and biological DMARDs; and secondly an observational clinical dataset from Italy of patients receiving biological DMARDs. Proportions achieving each of the four potential targets were calculated in each dataset and comparisons between treatment groups were performed in the TICOPA dataset. Levels of residual disease were established for key clinical domains of PsA. Results: All measures could differentiate the TICOPA trial treatment groups (p<0.03). Lower proportions of patients fulfilled the VLDA criteria compared to DAPSA or cDAPSA remission. PASDAS results were different between the cohorts. Residual active disease was low across all definitions although higher levels were seen in DAPSA and cDAPSA compared to VLDA, particularly for psoriasis. In all measures, the proportion with elevated CRP was similar and low. Conclusion: VLDA appears the most stringent measure. It ensures that significant active arthritis, enthesitis and psoriasis are not present in contrast with DAPSA and PASDAS where composite scores can 'hide' active disease in some domains. Key index terms-psoriatic arthritis, treat to target, outcome measures,

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“…The CPDAI has good responsiveness to change and differentiates between drug plus placebo (101,108,119) and active comparators (122,127). It also has good responsiveness in LOS (121).…”

Section: Composite Psoriatic Disease Activity Indexmentioning

confidence: 99%

Measuring Outcomes in Psoriatic Arthritis

Ogdie

Coates

Mease

2020

Arthritis Care & Research

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The dynamics of response as measured by multiple composite outcome tools in the TIght COntrol of inflammation in early Psoriatic Arthritis (TICOPA) trial

Abstract: Background

Cited by 21 publications

References 12 publications

Disease-specific composite measures for psoriatic arthritis are highly responsive to a Janus kinase inhibitor treatment that targets multiple domains of disease

Disease-specific composite measures for psoriatic arthritis are highly responsive to a Janus kinase inhibitor treatment that targets multiple domains of disease

075. what Should Be the Primary Target of Treat to Target in Psoriatic Arthritis?

Measuring Outcomes in Psoriatic Arthritis

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