Trial reportAnnals of the rheumatic diseases2015
Sarilumab for the treatment of ankylosing spondylitis: results of a Phase II, randomised, double-blind, placebo-controlled study (ALIGN).
Trial report in Annals of the rheumatic diseases, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01061723 (A Randomized Double Blind-placebo Controlled Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 in Participants With Ankylosing Spondylitis), which is not on this map. Cited by 70 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.
A Randomized Double Blind-placebo Controlled Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 in Participants With Ankylosing Spondylitis (AS)
Who cites it
70 citing papers in PubMed, 5 syntheses or guidelines pooled it, 152 citations in OpenAlex.
- 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
- [Long version on the S3 guidelines for axial spondyloarthritis including Bechterew's disease and early forms, Update 2019 : Evidence-based guidelines of the German Society for Rheumatology (DGRh) and participating medical scientific specialist societies and other organizations].Zeitschrift fur Rheumatologie · 2019Guideline
- Risk of Infections and Cancer in Patients With Rheumatologic Diseases Receiving Interleukin Inhibitors: A Systematic Review and Meta-analysis.JAMA network open · 2019Pooled it
- Risk of serious infections in biological treatment of patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis: a meta-analysis.Clinical rheumatology · 2018Pooled it
- Ziltivekimab for Treatment of Anemia of Inflammation in Patients on Hemodialysis: Results from a Phase 1/2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial.Journal of the American Society of Nephrology : JASN · 2021Trial
- Sarilumab plus methotrexate in patients with active rheumatoid arthritis and inadequate response to methotrexate: results of a randomized, placebo-controlled phase III trial in Japan.Arthritis research & therapy · 2019Trial
- Effect of Secukinumab on Patient-Reported Outcomes in Patients With Active Ankylosing Spondylitis: A Phase III Randomized Trial (MEASURE 1).Arthritis & rheumatology (Hoboken, N.J.) · 2016Trial
- Assessment of short-term symptomatic efficacy of tocilizumab in ankylosing spondylitis: results of randomised, placebo-controlled trials.Annals of the rheumatic diseases · 2014Trial
- The Th17/Treg axis: a key to understanding and treating autoimmune disorders.Open life sciences · 2026Article
- Global research trends in biological therapy for ankylosing spondylitis: A comprehensive visualization and bibliometric study (2004-2023).Human vaccines & immunotherapeutics · 2025Article
- Treatment of indolent systemic mastocytosis with sarilumab is not supported in a randomized trial.The journal of allergy and clinical immunology. Global · 2025Article
- Multi-omic insights from a multi-ancestry genome-wide meta-analysis of ankylosing spondylitis reveal novel pathways of disease susceptibility.Research square · 2025Article
- The Causal Relationships and Therapeutic Targets of Plasma Proteins in Ankylosing Spondylitis.Biomedicines · 2025Article
- Osteoimmunology of Spondyloarthritis.International journal of molecular sciences · 2023Review
- Have Therapeutics Enhanced Our Knowledge of Axial Spondyloarthritis?Current rheumatology reports · 2023Review
- Efficacy and safety of IL inhibitors, TNF-α inhibitors, and JAK inhibitors in patients with ankylosing spondylitis: a systematic review and Bayesian network meta-analysis.Annals of translational medicine · 2023Article
- Therapeutic Utility and Adverse Effects of Biologic Disease-Modifying Anti-Rheumatic Drugs in Inflammatory Arthritis.International journal of molecular sciences · 2022Review
- Hyper/neuroinflammation in COVID-19 and suicide etiopathogenesis: Hypothesis for a nefarious collision?Neuroscience and biobehavioral reviews · 2022Review
- Monocytes and Macrophages in Spondyloarthritis: Functional Roles and Effects of Current Therapies.Cells · 2022Review
10 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 5 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesThe ALIGN study (NCT01061723) evaluated the efficacy and safety of sarilumab, the first fully human monoclonal antibody against interleukin-6 receptor-α (IL-6Rα), in patients with ankylosing spondylitis (AS).
methodsPatients with active AS despite conventional treatment were randomised to placebo, or one of five subcutaneous dose regimens of sarilumab (100, 150 or 200 mg every other week, or 100 or 150 mg every week), for 12 weeks. The primary efficacy end point was the percentage of patients achieving the Axial SpondyloArthritis international Society (ASAS) 20 response criteria at week 12. Secondary endpoints included ASAS40 response, ASAS partial remission, AS Disease Activity Score, high-sensitivity C-reactive protein (hs-CRP) value, and safety.
resultsBaseline demographic and disease characteristics of the 301 patients enrolled were similar across treatment groups. At week 12, there was no statistically significant difference in ASAS20 response rate between placebo (ASAS20 = 24.0%) and any sarilumab dose group. A significantly greater reduction in hs-CRP value was achieved with the higher sarilumab doses versus placebo. No other statistically significant differences were evident for secondary efficacy endpoints. The most common treatment-emergent adverse events reported for sarilumab included infections (non-serious), neutropenia, and increase in alanine aminotransferase. No cases of tuberculosis, opportunistic, or fungal infections, or bowel perforations were reported. Seven patients experienced a treatment-emergent serious adverse event (all in sarilumab treatment groups). No deaths occurred.
conclusionsThe ALIGN study shows that IL-6Rα blockade with sarilumab was not an effective treatment for AS. Sarilumab was generally well tolerated with a manageable safety profile.
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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 OpenQuestion graph.