GO-DACT: a phase 3b randomised, double-blind, placebo-controlled trial of GOlimumab plus methotrexate (MTX) versus placebo plus MTX in improving DACTylitis in MTX-naive patients with psoriatic arthritis

Vieira-Sousa, Elsa; Alves, Pedro Augusto; Rodrigues, Ana Maria; Teixeira, Filipa; Tavares-Costa, José; Bernardo, Alexandra; Pimenta, Sofia; Pimentel-Santos, Fernando; Gomes, Joao Lagoas; Aguiar, Renata; Pinto, Patrícia; Videira, Taciana; Catita, Cristina; Santos, Helena; Borges, Joana; Sequeira, Graça; Ribeiro, Cristina; Teixeira, L.; Ribeiro, Pedro; Martins, Fernando; Canhão, Helena; McInnes, Iain B.; Ribeiro, Ruy M.; Fonseca, João Eurico

doi:10.1136/annrheumdis-2019-216500

Cited by 44 publications

(59 citation statements)

References 30 publications

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“…Thus, we included 35 trials in the systematic review. In addition, four trials ( 17 – 20 ) did not mention the portion of nail involvement or enrolled patients with nail psoriasis, the remaining 31 trials included 17,254 patients with psoriasis, and 10,720 (62.1%) had nail involvement. The flow diagram is shown in Figure 1 , and Supplementary Figure 1 provides the quality assessment for the included trials.…”

Section: Resultsmentioning

confidence: 99%

“…The median improvement in NAPSI score from baseline to weeks 14 and 24 was significantly greater ( P < 0.001) in the golimumab 50 mg group (25, 43%) and the golimumab 50 mg group (33, 54%) compared to that in the placebo group (0, 0%, respectively). Vieira-Sousa et al ( 20 ) evaluated methotrexate monotherapy or combination therapy with golimumab in 44 patients. After 12 weeks of treatment, the medium percentage of reduction in target fingernail NAPSI score (0–8) from baseline for combination therapy was greater than that of methotrexate monotherapy (−2 vs. 0, P = 0.044).…”

Section: Resultsmentioning

confidence: 99%

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Efficacy of Systemic Treatments of Nail Psoriasis: A Systemic Literature Review and Meta-Analysis

Zhang

Xie

2021

Front. Med.

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Importance: Nail involvement is a common condition in patients with psoriasis. The treatment of nail psoriasis is considered challenging and is often left untreated by physicians.Objective: To assess the efficacy of current systemic treatments on nail psoriasis.Data Sources: PubMed, EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL) were searched for relevant articles from inception to September 1, 2020. Included articles were restricted to English language and human studies.Study Selection: This was a systematic literature review with meta-analysis. Thirty-five random control trials that evaluated systemic therapies for nail psoriasis were selected in the systemic review. Among them, we retained 14 trials for meta-analysis.Data Extraction and Synthesis: This study was conducted in accordance with the preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. All steps were performed by two independent investigators, and any disagreements were resolved by a third investigator. Meta-analysis of aggregated study data was conducted to assess therapeutic efficacy. The use of random-effects model was based on high heterogeneity as a variable endpoint in different studies.Main Outcomes and Measures: Therapeutic effects on nail psoriasis were expressed in terms of effect sizes with 95% CIs.Results: We included 35 random control trials (RCTs) in this systemic review. At baseline, a high prevalence (62.1%) of nail psoriasis was confirmed. The meta-analysis included 14 trials highlighting that biologic and small-molecule therapies were effective in treating nail psoriasis with variable effect size magnitudes [−0.89 (−1.10, −0.68), I2 = 84%]. In particular, tofacitinib and ixekizumab showed the most significant scale of effect size magnitudes in treating nail psoriasis (−1.08 points and −0.93 points, respectively). We also found that a higher dose of tofacitinib and ixekizumab had similar effectiveness, and anti-IL-17 agents seem to be superior in effectiveness compared to anti-TNF-α therapies in the treatment of nail psoriasis. However, these results must be displayed carefully as variable endpoints in different studies.Conclusions and Relevance: This study provides a comprehensive overview of systemic treatments for nail psoriasis. For patients with psoriatic nail damage who are candidates of systemic therapies, the priority should be given to administering biologic and small-molecule therapies, especially anti-IL-17 drugs.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Efficacy of Systemic Treatments of Nail Psoriasis: A Systemic Literature Review and Meta-Analysis

Zhang

Xie

2021

Front. Med.

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“…To date there is only one study addressing dactylitis as a primary endpoint, the GO-DACT study, 31 a multicentre, randomized, double-blind, placebo-controlled, phase-3b trial of golimumab plus methotrexate (MTX) versus placebo plus MTX, in MTX-naïve and biologic disease-modifying anti-rheumatic drugs (bDMARDs) naïve patients with PsA and active dactylitis. The primary endpoint was DSS change from baseline to week 24.…”

Section: Current Treatment Strategiesmentioning

confidence: 99%

“…The GO-DACT trial showed that the combination of golimumab plus MTX is associated with significantly greater clinical improvements in dactylitis in comparison with MTX monotherapy. 31 …”

Section: Current Treatment Strategiesmentioning

confidence: 99%

Corticosteroid injection treatment for dactylitis in psoriatic arthritis

Carriero

Lubrano

Valentina

et al. 2021

Therapeutic Advances in Musculoskeletal

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Dactylitis – a hallmark clinical feature of psoriatic arthritis (PsA) – that occurs in 30–50% of PsA patients, is a marker of disease severity for PsA progression, an independent predictor of cardiovascular morbidity and impairs the motor functions of PsA patients. There is a paucity of evidence for the treatment due to the absence of randomized controlled trials assessing dactylitis as a primary endpoint and current practice arises from the analysis of dactylitis as a secondary outcome. Corticosteroid (CS) injections for dactylitis in PsA patients are a therapeutic treatment option for patients with isolated dactylitis or for patients with flares in tendon sheaths, despite stable and effective systemic treatment. The aim of this narrative review is to briefly illustrate the clinical aspects of dactylitis in PsA, the imaging and clinimetric tools used to diagnose and monitor dactylitis, the current treatment strategies and principally to provide a comprehensive picture of the clinical efficacy and safety with ultrasound-guide and blind techniques of CS injections for dactylitis in PsA patients.

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“…107 Of interest, weight loss was observed at 52 weeks, suggesting that APR could have a positive impact on obesity and metabolic syndrome. 108 To date, there is no evidence to demonstrate an impact of APR on structural disease progression: the results from PALACE analysis indicated significant improvements in the 42 Phase IV (EDUCATE) 194 Phase IV (REPArE) 195 Observational study (ADEQUATE 45 Observational study (GO-NICE) 202 Phase IIIb (GO-DACT) 203 Phase III (GOLMEPsA) numbers of swollen and tender joints over 5 years of treatment, that may have been associated with inhibition of disease progression. 104 Nevertheless data from real life studies have recently evidenced that APR is able to induce an early and sustained improvement on ultrasonographic inflammatory status at articular and peri-articular level.…”

Section: Targeted Synthetic Dmardsmentioning

confidence: 99%

<p>An Update for the Clinician on Biologics for the Treatment of Psoriatic Arthritis</p>

Chimenti¹,

D’Antonio²,

Conigliaro³

et al. 2020

BTT

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Psoriatic arthritis (PsA) is a chronic inflammatory arthropathy typically associated with psoriasis (PsO). The pathogenesis is strictly related to the association among the presence of genetic risk alleles and innate and acquired immune response with dramatic consequences on bone remodeling. Clinically, PsA patients may present heterogenicity of articular and periarticular manifestations that may be associated with the presence of comorbidities making treatment decision challenging in patients management. The identification of patient-targeted therapies is still a critical issue. Actually, several biological and synthetic drugs are promising in terms of efficacy and safety profile. National and international treatment recommendations support clinicians in the decision of the best treatment, although they may have limits basically related to updates and different outcomes included in the clinical studies evaluated. The aim of this narrative review is therefore to give guidance for clinicians for PsA patients treatment. For this purpose, we evaluated evidence on biological therapies efficacy used for PsA treatment. Specifically, we reviewed data on biological therapies, Janus kinases (JAK) inhibitors, and drugs with a new mechanism of action that are part of the treatment pipeline. The concept of "switching" and "swapping" is also described, as well as data concerning special populations such as pregnant women and elderly patients.

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GO-DACT: a phase 3b randomised, double-blind, placebo-controlled trial of GOlimumab plus methotrexate (MTX) versus placebo plus MTX in improving DACTylitis in MTX-naive patients with psoriatic arthritis

Cited by 44 publications

References 30 publications

Efficacy of Systemic Treatments of Nail Psoriasis: A Systemic Literature Review and Meta-Analysis

Efficacy of Systemic Treatments of Nail Psoriasis: A Systemic Literature Review and Meta-Analysis

Corticosteroid injection treatment for dactylitis in psoriatic arthritis

<p>An Update for the Clinician on Biologics for the Treatment of Psoriatic Arthritis</p>

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