Trial reportRMD open2020
Methotrexate effect on immunogenicity and long-term maintenance of adalimumab in axial spondyloarthritis: a multicentric randomised trial.
Trial report in RMD open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01895764 (Effect of the Combination of Methotrexate and Adalimumab on Reduction of Immunization in Ankylosing Spondylitis), which is not on this map. Cited by 31 papers, 3 of them syntheses that pooled it.
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.
Effect of the Combination of Methotrexate and Adalimumab on Reduction of Immunization in Ankylosing Spondylitis (COMARIS)
Who cites it
31 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Sex-Related Differences in Efficacy and Safety Outcomes in Axial Spondyloarthritis Randomized Clinical Trials: A Systematic Literature Review and Meta-Analysis.Arthritis care & research · 2025Pooled it
- Pooled it
- The Risk of Adverse Effects of TNF-α Inhibitors in Patients With Rheumatoid Arthritis: A Network Meta-Analysis.Frontiers in immunology · 2022Pooled it
- The role of antidrug antibodies in ustekinumab therapy and the impact of methotrexate.Rheumatology (Oxford, England) · 2023Trial
- Treatment of Juvenile Spondyloarthritis: Where We Stand.Paediatric drugs · 2020Trial
- Methotrexate's effect on cells and adalimumab immunogenicity in axial spondyloarthritis: A mathematical study.PLoS computational biology · 2026Article
- Review
- Therapeutic drug monitoring of adalimumab in hidradenitis suppurativa: a prospective observational study.Frontiers in immunology · 2026Observational
- Trends in immunomodulatory therapy for the treatment of chronic uveitis in the United States.Journal of ophthalmic inflammation and infection · 2025Article
- Clinical Implications of Point-of-Care Measurement of Adalimumab Concentration and Anti-Adalimumab Antibodies in Patients with Rheumatoid Arthritis and Ankylosing Spondylitis.International journal of molecular sciences · 2025Article
- Understanding and addressing anti-drug antibody formation in tumor necrosis factor-α inhibitor therapy for ankylosing spondylitis.Journal of rheumatic diseases · 2025Article
- Predictive Factors for COVID-19 Severity in Patients with Axial Spondyloarthritis: Real-World Data from the Romanian Registry of Rheumatic Diseases.Medicina (Kaunas, Lithuania) · 2025Observational
- Immunogenicity risk assessment and mitigation for engineered antibody and protein therapeutics.Nature reviews. Drug discovery · 2024Review
- Drug Interaction-Informed Approaches to Inflammatory Bowel Disease Management.Pharmaceutics · 2024Review
- Factors Associated with the Development of Anti-drug Antibodies to TNFi and the Consequences for Axial Spondyloarthritis: A Two-year Follow-up Study.European journal of rheumatology · 2024Article
- Efficacy, retention rate and safety of adalimumab treatment in patients with non-infectious uveitis and scleritis: a real-world, retrospective, single-centre study.Eye (London, England) · 2024Article
- Diagnosis and Management of Non-Infectious Uveitis in Pediatric Patients.Paediatric drugs · 2024Review
- Psoriatic arthritis: the role of self-reported non-adherence, non-trough drug levels, immunogenicity and conventional synthetic DMARD co-therapy in adalimumab and etanercept response.Rheumatology advances in practice · 2024Article
- Adults on pre-exposure prophylaxis (tenofovir-emtricitabine) have faster clearance of anti-HIV monoclonal antibody VRC01.Nature communications · 2023Article
- Response to Biologic Drugs in Patients With Rheumatoid Arthritis and Antidrug Antibodies.JAMA network open · 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
22 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesAnti-drug antibodies (ADA) are responsible for decreased adalimumab efficacy in axial spondyloarthritis (SpA). We aimed to evaluate the ability of methotrexate (MTX) to decrease adalimumab immunisation.
methodsA total of 110 patients eligible to receive adalimumab 40 mg subcutaneously (s.c.) every other week were randomised (1:1 ratio) to receive, 2 weeks before adalimumab (W-2) and weekly, MTX 10 mg s.c. (MTX+) or not (MTX-). ADA detection and adalimumab serum concentration were assessed at weeks 4 (W4), 8 (W8), 12 (W12) and 26 (W26) after starting adalimumab (W0). The primary outcome was the proportion of patients with ADA at W26. Four years after the study completion, we retrospectively analysed adalimumab maintenance in relation with MTX co-treatment duration.
resultsWe analysed data for 107 patients (MTX+; n=52; MTX-; n=55). ADA were detected at W26 in 39/107 (36.4%) patients: 13/52 (25%) in the MTX+ group and 26/55 (47.3%) in the MTX- group (p=0.03). Adalimumab concentration was significantly higher in the MTX+ than MTX- group at W4, W8, W12 and W26. The two groups did not differ in adverse events or efficacy. In the follow-up study, MTX co-treatment >W26 versus no MTX or ≤W26 was significantly associated with adalimumab long-term maintenance (p=0.04).
conclusionMTX reduces the immunogenicity and ameliorate the pharmacokinetics of adalimumab in axial SpA. A prolonged co-treatment of MTX>W26 seems to increase adalimumab long-term maintenance.
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