Trial reportArthritis care & research2015
Maintenance of Clinical Efficacy and Radiographic Benefit Through Two Years of Ustekinumab Therapy in Patients With Active Psoriatic Arthritis: Results From a Randomized, Placebo-Controlled Phase III Trial.
Trial report in Arthritis care & research, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers, 5 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
44 citing papers in PubMed, 5 syntheses or guidelines pooled it.
- The incidence of opportunistic infections in patients with psoriatic arthritis treated with biologic and targeted synthetic agents: A systematic review and meta-analysis.Frontiers in pharmacology · 2022Pooled it
- Management of particular clinical situations in psoriatic arthritis: an expert's recommendation document based on systematic literature review and extended Delphi process.Rheumatology international · 2021Pooled it
- Adverse Events Associated With Anti-IL-23 Agents: Clinical Evidence and Possible Mechanisms.Frontiers in immunology · 2021Pooled it
- Efficacy and safety of biologics in psoriatic arthritis: a systematic literature review and network meta-analysis.RMD open · 2020Pooled it
- A Systematic Review With Network Meta-Analysis of the Available Biologic Therapies for Psoriatic Disease Domains.Frontiers in medicine · 2020Pooled it
- Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn's Disease: An Integrated Analysis of Phase II/III Clinical Development Programs.Drug safety · 2019Trial
- Trial
- A randomised phase II study evaluating the efficacy and safety of subcutaneously administered ustekinumab and guselkumab in patients with active rheumatoid arthritis despite treatment with methotrexate.Annals of the rheumatic diseases · 2017Trial
- Real-world evidence of biological treatments in rheumatoid arthritis and spondyloarthritis in Morocco: results of the RBSMR registry.BMC rheumatology · 2025Article
- Beyond inflammation: the molecular basis of bone remodeling in axial spondyloarthritis and psoriatic arthritis.Frontiers in immunology · 2025Review
- Incidence and Course of Joint Inflammation Associated with Inflammatory Bowel Disease in Patients Undergoing Treatment with Vedolizumab/Ustekinumab: The VEDUSTAR Study.Journal of clinical medicine · 2024Article
- Infections in psoriatic arthritis: association with treatment.Therapeutic advances in musculoskeletal disease · 2024Review
- Review
- Inflammatory Cytokines in Psoriatic Arthritis: Understanding Pathogenesis and Implications for Treatment.International journal of molecular sciences · 2023Review
- Consensus on targeted drug therapy for spondyloarthritis.Rheumatology and immunology research · 2023Article
- Development of Antibodies to Ustekinumab Is Associated with Loss of Response in Patients with Inflammatory Bowel Disease.Journal of clinical medicine · 2023Article
- Genetic and Molecular Distinctions Between Axial Psoriatic Arthritis and Radiographic Axial Spondyloarthritis: Post Hoc Analyses from Four Phase 3 Clinical Trials.Advances in therapy · 2023Article
- Expression of genes related to inflammation - IL-6, IL-8, and IFN-γ in monitoring ustekinumab therapy: preliminary results.Postepy dermatologii i alergologii · 2022Article
- The role of IL-23 and the use of IL-23 inhibitors in psoriatic arthritis.Musculoskeletal care · 2022Review
- Article
Corrections and comments
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Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo evaluate the efficacy and safety of ustekinumab through 2 years in adult patients with active psoriatic arthritis (PsA).
methodsA total of 615 adult patients with active PsA were randomized to placebo, ustekinumab 45 mg, or ustekinumab 90 mg, at weeks 0, 4, and every 12 weeks through week 88 (last dose). At week 16, patients with <5% improvement in both tender and swollen joint counts entered blinded early escape (placebo to 45 mg, 45 mg to 90 mg, and 90 mg to 90 mg). All remaining placebo patients crossed over to ustekinumab 45 mg at week 24. Clinical efficacy measures included American College of Rheumatology criteria for 20% improvement (ACR20), Disease Activity Score in 28 joints using the C-reactive protein level (DAS28-CRP), and ≥75% improvement in the Psoriasis Area and Severity Index (PASI75). Radiographic progression was evaluated using the modified Sharp/van der Heijde score (SHS).
resultsAt week 100, ACR20, DAS28-CRP moderate/good response, and PASI75 rates ranged from 56.7-63.6%, 71.9-76.7%, and 63.9-72.5%, respectively, across the 3 treatment groups. In both ustekinumab groups, the median percent improvement in dactylitis and enthesitis was 100% at week 100. The mean changes in SHS score from week 52 to week 100 were similar to those observed from week 0 to week 52 in the ustekinumab groups. Through week 108, 70.7% and 9.7% of patients had an adverse event (AE) or serious AE, respectively. The rates and type of AEs were similar between the dose groups.
conclusionClinical and radiographic benefits from ustekinumab treatment were maintained through week 100 in the PSUMMIT 1 study. No unexpected safety events were observed; the safety profile of ustekinumab in this population was similar to that previously observed in psoriasis patients treated with ustekinumab.
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