Achieving sustained minimal disease activity with methotrexate in early interleukin 23-driven early psoriatic arthritis

Braanker, Hannah den; Wervers, Kim; Mus, Anne‐Marie; Bangoer, Priyanka S; Davelaar, Nadine; Luime, Jolanda J.; Tchetverikov, I.; Hazes, Johanna M. W.; Vis, Marijn; Lubberts, Erik; Kok, Marc R.

doi:10.1136/rmdopen-2020-001175

Cited by 5 publications

(3 citation statements)

References 32 publications

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“…IL-23 is involved in the activation and proliferation of Th17 cells linked to sustained inflammatory responses in the skin and joints in PsA, and anti-IL-23 antibodies have shown efficacy in PsO and PsA 2 12. Patients with early PsA who do not achieve MDA with standard methotrexate therapy have higher levels of IL-23 than those who respond to methotrexate 13…”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of selective TYK2 inhibitor, deucravacitinib, in a phase II trial in psoriatic arthritis

et al. 2022

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ObjectiveTo evaluate the efficacy and safety of an oral selective tyrosine kinase 2 (TYK2) inhibitor, deucravacitinib, in patients with active psoriatic arthritis (PsA).MethodsIn this double-blind, phase II trial, 203 patients with PsA were randomised 1:1:1 to placebo, deucravacitinib 6 mg once a day or 12 mg once a day. The primary endpoint was American College of Rheumatology-20 (ACR-20) response at week 16.ResultsACR-20 response was significantly higher with deucravacitinib 6 mg once a day (52.9%, p=0.0134) and 12 mg once a day (62.7%, p=0.0004) versus placebo (31.8%) at week 16. Both deucravacitinib doses resulted in significant improvements versus placebo (p≤0.05) in the multiplicity-controlled secondary endpoints of change from baseline in Health Assessment Questionnaire-Disability Index and Short Form-36 Physical Component Summary score and in Psoriasis Area and Severity Index-75 response. Improvements were also seen in multiple exploratory endpoints with deucravacitinib treatment. The most common adverse events (AEs) (≥5%) in deucravacitinib-treated patients were nasopharyngitis, upper respiratory tract infection, sinusitis, bronchitis, rash, headache and diarrhoea. There were no serious AEs and no occurrence of herpes zoster, opportunistic infections and major adverse cardiovascular events, or differences versus placebo in mean changes in laboratory parameters with deucravacitinib treatment.ConclusionsTreatment with the selective TYK2 inhibitor deucravacitinib was well tolerated and resulted in greater improvements than placebo in ACR-20, multiplicity-controlled secondary endpoints and other exploratory efficacy measures in patients with PsA. Larger trials over longer periods of time with deucravacitinib are warranted to confirm its safety profile and benefits in PsA.Trial registration numberNCT03881059.

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Section: Introductionmentioning

confidence: 99%

Efficacy and safety of selective TYK2 inhibitor, deucravacitinib, in a phase II trial in psoriatic arthritis

et al. 2022

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“…Few studies have specifically analysed the efficacy and safety of the selected drugs in patients with early PsA [ 91 ]. Inadequate response with MTX monotherapy in this sub-group of patients has been reported [ 20 , 126 ], but a RCT and open-label extension recently published observed that around half of patients with early PsA achieved remission with initial combination treatment of MTX + TNF inhibitors that was maintained with MTX monotherapy afterwards [ 127 ].…”

Section: Resultsmentioning

confidence: 99%

Management of particular clinical situations in psoriatic arthritis: an expert’s recommendation document based on systematic literature review and extended Delphi process

et al. 2021

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To establish practical recommendations for the management of patients with psoriatic arthritis (PsA) with particular clinical situations that might lead to doubts in the pharmacological decision-making. A group of six expert rheumatologists on PsA identified particular clinical situations in PsA. Then, a systematic literature review (SLR) was performed to analyse the efficacy and safety of csDMARDs, b/tsDMARDs in PsA. In a nominal group meeting, the results of the SLR were discussed and a set of recommendations were proposed for a Delphi process. A total of 65 rheumatologists were invited to participate in the Delphi. Agreement was defined if ≥ 70% of the participants voted ≥ 7 (from 1, totally disagree to 10, totally agree). For each recommendation, the level of evidence and grade of recommendation was established based on the Oxford Evidence-Based Medicine categorisation. Particular clinical situations included monoarthritis, axial disease, or non-musculoskeletal manifestations. The SLR finally comprised 131 articles. A total of 16 recommendations were generated, all but 1 reached consensus. According to them, it is crucial to carefully analyse the impact of individual manifestations on patients (disability, quality of life, etc.), but also to recognise the impact of each drug singularities on selected clinical phenotypes to adopt the most appropriate treatment strategy. Early diagnosis and treatment to target approach, along with a close risk management, is also necessary. These recommendations are intended to complement gaps in national and international guidelines by helping health professionals address and manage particular clinical situations in PsA.

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“…These findings were supported by studies that classified the same patients using both metrics, allowing residual disease to be more accurately compared between ‘equivalent’ groups. In the DEPAR study for example, prevalence of > 1 residual tender or swollen joints, > 1 tender entheseal points, PASI > 1, PtP VAS > 15, PtGA VAS > 20 or HAQ-DI > 0.5 was lower among MDA-achievers than among DAPSA LDA-achievers [ 22 , 45 , 67 – 70 ]. Across the MDA metric and DAPSA, we noted that these listed thresholds were most often exceeded for PASI, PtP and PtGA.…”

Section: Discussionmentioning

confidence: 99%

Residual Disease Associated with Suboptimal Treatment Response in Patients with Psoriatic Arthritis: A Systematic Review of Real-World Evidence

et al. 2022

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Objective This systematic literature review aimed to identify and summarise real-world observational studies reporting the type, prevalence and/or severity of residual symptoms and disease in adults with psoriatic arthritis (PsA) who have received treatment and been assessed against remission or low disease activity targets. Methods Patients had received treatment and been assessed with treat-to-target metrics, including minimal disease activity (MDA), Disease Activity Index in PsA (DAPSA) and others. MEDLINE, Embase® and the Cochrane Database of Systematic Reviews (CDSR) were searched using search terms for PsA, treatment targets and observational studies. Screening of search results was completed by two independent reviewers; studies were included if they reported relevant residual disease outcomes in adults with PsA who had received one or more pharmacological treatments for PsA in a real-world setting. Non-observational studies were excluded. Information from included studies was extracted into a prespecified grid by a single reviewer and checked by a second reviewer. Results Database searching yielded 2328 articles, of which 42 publications (27 unique studies) were included in this systematic literature review. Twenty-three studies reported outcomes for MDA-assessed patients, and 14 studies reported outcomes for DAPSA-assessed patients. Physician- and patient-reported residual disease was less frequent and/or severe in patients reaching targets, but often not absent, including when patients achieved very low disease activity (VLDA) or remission. For example, studies reported that 0–8% patients in remission according to DAPSA (or clinical DAPSA) had > 1 tender joint, 25–39% had Psoriasis Area and Severity Index (PASI) score > 1 and 0–10% had patient-reported pain > 15. Residual disease was usually less frequent and/or severe among patients achieving MDA-assessed targets versus DAPSA-assessed targets, especially for skin outcomes. Conclusion The findings demonstrate a need for further optimisation of care for patients with PsA.

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Achieving sustained minimal disease activity with methotrexate in early interleukin 23-driven early psoriatic arthritis

Cited by 5 publications

References 32 publications

Efficacy and safety of selective TYK2 inhibitor, deucravacitinib, in a phase II trial in psoriatic arthritis

Efficacy and safety of selective TYK2 inhibitor, deucravacitinib, in a phase II trial in psoriatic arthritis

Management of particular clinical situations in psoriatic arthritis: an expert’s recommendation document based on systematic literature review and extended Delphi process

Residual Disease Associated with Suboptimal Treatment Response in Patients with Psoriatic Arthritis: A Systematic Review of Real-World Evidence

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