Trial reportAmerican journal of clinical dermatology2022
Switching Between Adalimumab Reference Product and BI 695501 in Patients with Chronic Plaque Psoriasis (VOLTAIRE-X): A Randomized Controlled Trial.
Trial report in American journal of clinical dermatology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03210259 (VOLTAIRE-X), which is not on this map. Cited by 15 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
VOLTAIRE-X: Pharmacokinetics, Safety, Immunogenicity and Efficacy of BI 695501 Versus Humira® in Patients With Moderate to Severe Chronic Plaque Psoriasis: a Randomized, Double-blind, Parallel-arm, Multiple-dose, Active Comparator Trial
Who cites it
15 citing papers in PubMed, 27 citations in OpenAlex.
- Multiple Switches Between Adalimumab-fkjp and Reference Adalimumab in Moderate-to-Severe Chronic Plaque Psoriasis: A Multicenter, Double-Blind, Parallel Group, Randomized Clinical Trial for Interchangeability.Advances in therapy · 2025Trial
- A Randomised, Double-Blind Trial to Compare the Efficacy, Safety, and Immunogenicity of the Biosimilar Ustekinumab FYB202 with Reference Ustekinumab in Patients with Moderate-to-Severe Plaque Psoriasis.Advances in therapy · 2025Trial
- Antidrug antibodies to adalimumab do not associate with immunologically related adverse events.Frontiers in immunology · 2024Trial
- Evaluating the feasibility of health care databases for assessing the safety of switching between originator biologics and biosimilars.Journal of managed care & specialty pharmacy · 2026Article
- Switching from Adalimumab Reference Product to and Among Adalimumab Biosimilars Outside the USA: Insights for US Clinicians.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025Review
- Biosimilars versus biological therapy in inflammatory bowel disease: challenges and targeting strategies using drug delivery systems.Clinical and experimental medicine · 2025Review
- From the Masterclasses in Dermatology 2024 Meeting: Updates in Psoriasis Treatments.The Journal of clinical and aesthetic dermatology · 2025Review
- Effectiveness and Safety of Adalimumab Biosimilars in Pediatric Psoriasis: A Multi-Center International Experience.Psoriasis (Auckland, N.Z.) · 2025Article
- Biosimilars for the Treatment of Moderate to Severe Chronic Plaque Psoriasis.Psoriasis (Auckland, N.Z.) · 2025Review
- Effects of Adalimumab-adbm Versus Adalimumab Reference Product on Patient-Reported Outcomes in Rheumatoid Arthritis: Results from VOLTAIRE-RA.Rheumatology and therapy · 2024Article
- Clinical Guide to Navigating the Landscape of Biosimilars for Inflammatory Bowel Disease.Gastroenterology & hepatology · 2024Article
- Biosimilars in IBD: What Every Clinician Needs to Know.Current gastroenterology reports · 2024Review
- Biosimilars in Dermatology Review.Journal of psoriasis and psoriatic arthritis · 2024Review
- Anti-TNFα in inflammatory bowel disease: from originators to biosimilars.Frontiers in pharmacology · 2024Review
- Summary of Research: Switching Between Adalimumab Reference Product and BI 695501 in Patients with Chronic Plaque Psoriasis (VOLTAIRE-X): A Randomized Controlled Trial.Dermatology and therapy · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 8 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundBI 695501 is an FDA-approved biosimilar to adalimumab reference product (RP). VOLTAIRE-X was a randomized clinical trial to assess outcomes with a biosimilar monoclonal antibody in line with the FDA requirements for designation as an 'interchangeable' biosimilar.
objectiveThe aim of this study was to assess whether multiple switches between adalimumab RP and BI 695501 lead to equivalent pharmacokinetics and a similar safety and immunogenicity profile compared with continuous adalimumab RP.
methodsWe conducted a phase III, double-blind, randomized controlled trial between July 19, 2017, and April 16, 2019. There were 49 investigational sites across Europe and North America. Of 323 screened patients with moderate-to-severe chronic plaque psoriasis, 259 were treated with adalimumab RP during the run-in period. Of these, 118 and 120 were randomized to the continuous or switching arms, respectively. Interventions consisted of a run-in period with adalimumab RP 80 mg subcutaneously (SC) on Day 1, then 40 mg SC every other week (EOW) Weeks 2-12. Patients were then randomized to receive adalimumab RP 40 mg EOW Weeks 14-48 (continuous arm) or BI 695501 40 mg Weeks 14 and 16, adalimumab RP 40 mg Weeks 18 and 20, and BI 695501 40 mg EOW Weeks 22 to 48 (switching arm); all interventions were given SC. Primary endpoints were pharmacokinetics parameters, area under the plasma concentration-time curve (AUC
results238 patients (mean [standard deviation] age 44.9 [13.8]; 66.0% male) were treated in the switching (n = 118) or continuous arms (n = 120). Adjusted mean C
conclusionsPharmacokinetic equivalence was demonstrated, with highly similar efficacy and immunogenicity, and comparable safety observed in patients with chronic plaque psoriasis who received either adalimumab RP continuously or who switched between adalimumab RP and BI 695501.
trial registrationClinicalTrials.gov: NCT03210259 (registered July 2017); Eudract.ema.europa.eu: 2016-002254-20.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.