Drug survival and effectiveness of ustekinumab in patients with psoriatic arthritis. Real-life data from the biologic Apulian registry (BIOPURE)

Iannone, Florenzo; Santo, Leonardo; Bucci, Romano; Semeraro, Angelo; Carlino, Giorgio; Paoletti, F; Quarta, L.; Leucci, Pierfrancesco; Zuccaro, C.; Marsico, A.; Scioscia, Crescenzio; Donofrio, Francesca; Mazzotta, Daniela; Muratore, Maurizio; Cantatore, Francesco Paolo; Lapadula, Giovanni

doi:10.1007/s10067-018-3989-2

Cited by 31 publications

(25 citation statements)

References 22 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Confounding by indication was possible; disease severity was generally mild in all cohorts and was within the same range across existing and initiated therapy, but some differences were seen for prior csDMARD use. Previous registry studies provided similar results but were conducted either outside the United States [25][26][27][28][29][30][31][32][33][34][35][36][37][38][39] or they used a subset of PsA patients from a registry in the United States that was designed primarily for patients with rheumatoid arthritis [40][41][42][43]. Our study used data from a registry in the United States that was specifically designed to collect information about patients with PsA.…”

Section: Discussionmentioning

confidence: 95%

Persistence of tumor necrosis factor inhibitor or conventional synthetic disease-modifying antirheumatic drug monotherapy or combination therapy in psoriatic arthritis in a real-world setting

Mease

Accortt

Rebello³

et al. 2019

Rheumatol Int

View full text Add to dashboard Cite

This study described treatment patterns in a psoriatic arthritis (PsA) patient registry for new or ongoing tumor necrosis factor inhibitor (TNFi) monotherapy, conventional synthetic disease-modifying antirheumatic drug (csDMARD) monotherapy, or TNFi/csDMARD combination therapy. This retrospective analysis included adults with PsA who enrolled in the Corrona PsA/ spondyloarthritis registry between March 21, 2013 (registry initiation), and January 31, 2017, and received an approved TNFi and/or csDMARD as "existing use" starting before registry entry or "initiated use" starting on/after registry entry. Therapy persistence was defined as index therapy use for ≥ 12 months without a treatment gap of ≥ 30 days. Among the evaluable patients with existing TNFi monotherapy (n = 251), csDMARD monotherapy (n = 225), and combination therapy (n = 214), 93, 87, and 87% were persistent for ≥ 12 months, and another 6, 5, and 5%, respectively, had no change with < 12 months of follow-up after first use. Among evaluable patients who initiated use of TNFi monotherapy (n = 26), csDMARD monotherapy (n = 35), and combination therapy (n = 15), 50, 43, and 53% were persistent for ≥ 12 months, and another 27, 20, and 20%, respectively, had no change with < 12 months of follow-up after first use. After initiation of index therapy, most changes (19-27% of patients) were discontinuation; 4-13% switched biologic therapy during follow-up. The results of this analysis of real-world treatment patterns in a PsA patient registry suggest that nonpersistence for TNFi monotherapy, csDMARD monotherapy, or TNFi/csDMARD combination therapy occurs more commonly after initiation of therapy than in patients with existing therapy. Trial registration: NCT02530268.

show abstract

Section: Discussionmentioning

confidence: 95%

Persistence of tumor necrosis factor inhibitor or conventional synthetic disease-modifying antirheumatic drug monotherapy or combination therapy in psoriatic arthritis in a real-world setting

Mease

Accortt

Rebello³

et al. 2019

Rheumatol Int

View full text Add to dashboard Cite

show abstract

“…In this context several studies have found elevated serum IL-23 levels in patients with SpA, PsO and PsA [37][38][39][40][41][42]. Therefore, close control of inflammation by anti-IL-23 drugs may turn off the disease activity and consequently the structural damage [5,9,10,43].…”

Section: Discussionmentioning

confidence: 99%

Serum Interleukin 23 in Psoriatic Arthritis Patients: Relation to disease activity, physical function and health related quality of life

Elsawy

Helal

Shafei

et al. 2019

Aktuelle Rheumatologie

View full text Add to dashboard Cite

Objective To assess interleukin 23 (IL-23) levels in the sera of psoriatic arthritis (PsA) patients and to determine the relationship of IL-23 with different disease activity indices, physical function and quality of life (QoL). Methods Fifty PsA patients and 46 matched healthy controls were included in this study. Data including a detailed history, a thorough clinical examination, skin severity based on the Psoriasis Area and Severity Index (PASI), the Disease Activity index for Psoriatic Arthritis (DAPSA) and the Composite Psoriatic Disease Activity Index (CPDAI) were obtained for all patients. Physical function was assessed by the Health Assessment Questionnaire Disability Index (HAQ-DI) and health-related QoL was assessed using the Short Form Health Survey (SF-36), Psoriatic Arthritis Quality of Life (PsAQoL) and the Dermatology Life Quality Index (DLQI) were also assessed. Serum IL-23 levels were measured in the studied groups. Results The study included 23(46%) females and 27 (54%) males with a mean age of 42.78±12.33 years. The mean serum IL-23 level was significantly higher in PsA patients (50.89±13.86 pg/ml) than in controls (43.88±6.34 pg/ml) (p=0.006). There were significant correlations between serum IL-23 levels and different grades of DAPSA activity (p=0.007) and PASI (p=0.015). No significant correlations could be detected between serum IL-23 levels and (HAQ-DI, DLQI, SF-36 or PsAQoL). CPDAI and DAPSA were significantly correlated with DLQI, SF-36 and PsAQoL. Conclusion IL-23 is a useful biomarker for identifying joint activity or skin severity but not QoL or physical function.

show abstract

“…In general, ACR and PASI responses were achieved irrespective of MTX use among the overall study populations in both trials, though the response rates were somewhat numerically higher among patients who did not receive concomitant MTX than among those undergoing combination therapy of ustekinumab plus MTX 4–6. A recent analysis of real-world data from a patient registry (BIOPURE) provided findings similar to those from the PSUMMIT trials; biologic-naïve patients tended to have longer treatment persistence and better clinical outcomes than those who previously had an inadequate response to one or more anti-TNF therapies 11. In addition, there was no apparent effect of concomitant MTX use on ustekinumab treatment persistence in this registry.…”

Section: Discussionmentioning

confidence: 79%

Efficacy of ustekinumab in biologic-naïve patients with psoriatic arthritis by prior treatment exposure and disease duration: data from PSUMMIT 1 and PSUMMIT 2

et al. 2019

View full text Add to dashboard Cite

ObjectiveTo evaluate the efficacy of ustekinumab by prior treatment exposure and disease duration in tumour necrosis factor inhibitor (TNF)-naïve patients with psoriatic arthritis (PsA) in the PSUMMIT 1 and PSUMMIT 2 studies.MethodsIn the phase 3, randomised, placebo-controlled PSUMMIT 1 and PSUMMIT 2 studies, adults with active PsA for ≥6 months despite conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and/or non-steroidal anti-inflammatory drugs (NSAIDs) (PSUMMIT 1) or csDMARDs, NSAIDs and/or anti-TNF agents (PSUMMIT 2) were enrolled. Patients were randomised to subcutaneous injections of placebo, ustekinumab 45 mg or ustekinumab 90 mg at weeks 0 and 4 and every 12 weeks. Efficacy was assessed at week 24 using the American College of Rheumatology criteria and 28-joint count disease activity score using C reactive protein (DAS28-CRP); radiographical progression, enthesitis, and dactylitis were also assessed in this post hoc analysis.ResultsA total of 747 patients were included; all 747 were TNF-naïve, of which, 179 were methotrexate-naïve and TNF-naïve, and 146 were all csDMARD-naïve and TNF-naïve. At week 24, greater proportions of ustekinumab-treated patients had ≥20%/50%/70% improvement in American College of Rheumatology criteria (ACR20/ACR50/ACR70) responses, DAS28-CRP response and DAS28-CRP remission versus placebo in all three prior-treatment populations, with similar differences between treatment groups. Greater proportions of ustekinumab-treated patients also had complete resolution of enthesitis and dactylitis at week 24 across the three prior-treatment populations. Mean changes from baseline in total van der Heijde-Sharp Score at week 24 were generally smaller for ustekinumab-treated patients versus placebo but were statistically significant only in the full TNF-naïve population. Response rates for ACR20/ACR50/ACR70 were similar for TNF-naïve patients with PsA durations of <1 year, ≥1 to <3 years, and ≥3 years.ConclusionUstekinumab-treated patients demonstrated greater clinical response at week 24 compared with placebo regardless of prior treatment exposure and PsA disease duration.

show abstract

Drug survival and effectiveness of ustekinumab in patients with psoriatic arthritis. Real-life data from the biologic Apulian registry (BIOPURE)

Cited by 31 publications

References 22 publications

Persistence of tumor necrosis factor inhibitor or conventional synthetic disease-modifying antirheumatic drug monotherapy or combination therapy in psoriatic arthritis in a real-world setting

Persistence of tumor necrosis factor inhibitor or conventional synthetic disease-modifying antirheumatic drug monotherapy or combination therapy in psoriatic arthritis in a real-world setting

Serum Interleukin 23 in Psoriatic Arthritis Patients: Relation to disease activity, physical function and health related quality of life

Efficacy of ustekinumab in biologic-naïve patients with psoriatic arthritis by prior treatment exposure and disease duration: data from PSUMMIT 1 and PSUMMIT 2

Contact Info

Product

Resources

About