scholarly journals Experience of guselkumab usage in the treatment of patients with psoriatic arthritis in real clinical practice

2021 ◽  
Vol 15 (5) ◽  
pp. 89-95
Author(s):  
E. Yu. Loginova ◽  
Yu. L. Korsakova ◽  
T. V. Korotaeva
Keyword(s):  
Psoriatic Arthritis ◽  
Metabolic Disorders ◽  
Moderate Activity ◽  
Efficacy And Safety ◽  
Peripheral Arthritis ◽  
Drug Usage ◽  
Clinical Observations ◽  
Disease Modifying ◽  
Interleukin 23 ◽  
Disease Modifying Antirheumatic Drug

The article presents an analysis of literature on the efficacy and safety of a new biologic disease modifying antirheumatic drug usage, the interleukin 23 inhibitor – guselkumab (GUS) – in the treatment of patients with psoriatic arthritis (PsA). Two own clinical observations of GUS therapy are described. It has been demonstrated that in PsA of moderate activity and in severe to moderate psoriasis with nail damage, the use of GUS (100 mg at weeks 0 and 4, and then every 8 weeks), allows to achieve remission of peripheral arthritis, enthesitis and psoriasis by the 20th week of treatment as in the monotherapy regimen and in combination with methotrexate. When GUS is re-prescribed (re-treat) after a long break (10 months), its effectiveness is quickly and completely restored. The safety of GUS was confirmed in patients with comorbid pathology, in particular, Gilbert's syndrome, hyperuricemia, metabolic disorders (abdominal obesity).

scholarly journals A head-to-head comparison of the efficacy and safety of ixekizumab and adalimumab in biological-naïve patients with active psoriatic arthritis: 24-week results of a randomised, open-label, blinded-assessor trial

2019 ◽  
Vol 79 (1) ◽  
pp. 123-131 ◽  
Author(s):  
Philip J Mease ◽  
Josef S Smolen ◽  
Frank Behrens ◽  
Peter Nash ◽  
Soyi Liu Leage ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Psoriatic Arthritis ◽  
Treat To Target ◽  
Inadequate Response ◽  
Efficacy And Safety ◽  
Open Label ◽  
Disease Modifying ◽  
Blinded Assessor ◽  
Disease Modifying Antirheumatic Drug

ObjectivesTo compare efficacy and safety of ixekizumab (IXE) to adalimumab (ADA) in biological disease-modifying antirheumatic drug-naïve patients with both active psoriatic arthritis (PsA) and skin disease and inadequate response to conventional synthetic disease-modifying antirheumatic drug (csDMARDs).MethodsPatients with active PsA were randomised (1:1) to approved dosing of IXE or ADA in an open-label, head-to-head, blinded assessor clinical trial. The primary objective was to evaluate whether IXE was superior to ADA at week 24 for simultaneous achievement of a ≥50% improvement from baseline in the American College of Rheumatology criteria (ACR50) and a 100% improvement from baseline in the Psoriasis Area and Severity Index (PASI100). Major secondary objectives, also at week 24, were to evaluate whether IXE was: (1) non-inferior to ADA for achievement of ACR50 and (2) superior to ADA for PASI100 response. Additional PsA, skin, treat-to-target and quality-of-life outcome measures were assessed at week 24.ResultsThe primary efficacy endpoint was met (IXE: 36%, ADA: 28%; p=0.036). IXE was non-inferior for ACR50 response (IXE: 51%, ADA: 47%; treatment difference: 3.9%) and superior for PASI100 response (IXE: 60%, ADA: 47%; p=0.001). IXE had greater response versus ADA in additional PsA, skin, nail, treat-to-target and quality-of-life outcomes. Serious adverse events were reported in 8.5% (ADA) and 3.5% (IXE) of patients.ConclusionsIXE was superior to ADA in achievement of simultaneous improvement of joint and skin disease (ACR50 and PASI100) in patients with PsA and inadequate response to csDMARDs. Safety and tolerability for both biologicals were aligned with established safety profiles.

scholarly journals Ixekizumab is efficacious when used alone or when added to conventional synthetic disease-modifying antirheumatic drugs (cDMARDs) in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor inhibitors

RMD Open ◽  
2018 ◽  
Vol 4 (2) ◽  
pp. e000692 ◽  
Author(s):  
Peter Nash ◽  
Frank Behrens ◽  
Ana-Maria Orbai ◽  
Suchitrita S Rathmann ◽  
David H Adams ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Tumour Necrosis Factor ◽  
Tumour Necrosis ◽  
Short Form ◽  
Joint Disease ◽  
Inadequate Response ◽  
Efficacy And Safety ◽  
Disease Modifying ◽  
Necrosis Factor

ObjectiveTo conduct subset analyses of SPIRIT-P2 (NCT02349295) to investigate the efficacy and safety of ixekizumab versus placebo in three subgroups of patients with active psoriatic arthritis (PsA) according to the concomitant conventional synthetic disease-modifying antirheumatic drug (cDMARD) received: any background cDMARDs (including methotrexate), background methotrexate only, or none.MethodsPatients were randomised to receive placebo, ixekizumab 80 mg every 4 weeks (IXEQ4W) or every 2 weeks (IXEQ2W). Efficacy and safety were assessed when patients were subdivided according to cDMARD use at baseline. Efficacy was evaluated versus placebo at week 24 by the American College of Rheumatology criteria (ACR20/50), achievement of minimal disease activity (MDA) state, Disease Activity Index for PsA (DAPSA), 28-joint Disease Activity Score using C-reactive protein (DAS28-CRP), Health Assessment Questionnaire-Disability Index and the 36-item Short-Form health survey physical functioning domain.ResultsRegardless of background cDMARD status, ACR20, ACR50 and MDA response rates were significantly higher than placebo with IXEQ4W or IXEQ2W treatment. Similarly, significant improvements were observed relative to placebo for DAS28-CRP and DAPSA across subgroups. Physical function also significantly improved relative to placebo with IXEQ4W treatment regardless of background cDMARD status and with IXEQ2W alone. Percentages of reported treatment-emergent adverse events (AEs), serious AEs (including serious infections) and discontinuations due to AEs in each subgroup were comparable to the overall SPIRIT-P2 population.ConclusionIxekizumab was efficacious in patients with active PsA and previous tumour necrosis factor inhibitor (TNFi) inadequate response or TNFi intolerance treated with ixekizumab alone or when added to cDMARDs with subgroup safety profiles that were consistent with that observed in the overall SPIRIT-P2 population.

Efficacy and safety of ustekinumab in psoriatic arthritis patients with peripheral arthritis and physician-reported spondylitis: post-hoc analyses from two phase III, multicentre, double-blind, placebo-controlled studies (PSUMMIT-1/PSUMMIT-2)

2016 ◽  
Vol 75 (11) ◽  
pp. 1984-1988 ◽  
Author(s):  
Arthur Kavanaugh ◽  
Lluis Puig ◽  
Alice B Gottlieb ◽  
Christopher Ritchlin ◽  
Yin You ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Activity Index ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Peripheral Arthritis ◽  
Link Type ◽  
Study Results ◽  
Post Hoc

ObjectiveTo evaluate ustekinumab efficacy and safety in psoriatic arthritis (PsA) patients with peripheral arthritis and physician-reported spondylitis (termed the ‘spondylitis subset’).MethodsAdults with active PsA (PSUMMIT-1/PSUMMIT-2, n=615/312) were randomised to ustekinumab 45 mg, 90 mg or placebo at week 0/week 4/q12 week. At week 16, patients with <5% improvement in tender and swollen joints entered blinded early escape. A subset of patients with physician-identified spondylitis was evaluated with spondylitis-specific assessments, including Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score employing C reactive protein (ASDAS-CRP), through week 24.Results256/927 (27.6%) PSUMMIT-1/PSUMMIT-2 patients (placebo/ustekinumab, n=92/164) comprised the evaluable spondylitis subset. At week 24, in this analysis subset, significantly more patients achieved BASDAI20/50/70 responses (54.8%/29.3%/15.3% vs 32.9%/11.4%/0%; p≤0.002), improvement in BASDAI question 2 concerning axial pain (1.85 vs 0.24; p<0.001) and mean per cent ASDAS-CRP improvements (27.8% vs 3.9%; p<0.001) for ustekinumab versus placebo recipients, respectively. Comparable to the overall study population, significant improvements were also achieved in psoriasis, peripheral arthritis, enthesitis, dactylitis, physical function and peripheral joint radiographs in the spondylitis subset.ConclusionsIn this post-hoc analysis of PsA patients with baseline peripheral arthritis and physician-reported spondylitis, ustekinumab-treated patients demonstrated significant improvements in axial signs and symptoms through week 24.Trial registration numberPSUMMIT-1 (NCT01009086, EudraCT 2009-012264-14) and PSUMMIT-2 (NCT01077362, EudraCT 2009-012265-60); post-study results.

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