Evidence map›Paper›PMID 22772328›Full record

Trial reportAnnals of the rheumatic diseases2013

Efficacy and safety of adalimumab in patients with non-radiographic axial spondyloarthritis: results of a randomised placebo-controlled trial (ABILITY-1).

Joachim Sieper, Désirée van der Heijde, Maxime Dougados, Philip J Mease, Walter P Maksymowych, Matthew A Brown, Vipin Arora, Aileen L Pangan

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02709694 (Imaging Biomarkers in Crohn's Associated Spondyloarthritis), which is not on this map. Cited by 220 papers, 19 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
220citing papers in PubMed, 19 pooled it
39.8field-weighted citation impact, top 1% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT02709694 completednot on this mapstarted 2016, after this paper: background citation

Imaging Biomarkers in Crohn's Associated Spondyloarthritis

TypeobservationalSponsorHospital for Special Surgery, New YorkRan2016 to 2021Enrolled33ConditionsCrohn's Disease, SpondyloarthritisArmsNo intervention
3 · Its place in the literature

Who cites it

220 citing papers in PubMed, 19 syntheses or guidelines pooled it, 530 citations in OpenAlex.

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  3. Tumor necrosis factor (TNF) inhibitors for psoriatic arthritis.The Cochrane database of systematic reviews · 2025
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160 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 7 institutions in 6 countries.

Joachim SieperDepartment of Gastroenterology and Rheumatology, Charité Universitätsmedizin Berlin, Berlin, Germany. joachim.sieper@charite.de
Désirée van der Heijde
Maxime Dougados
Philip J Mease
Walter P Maksymowych
Matthew A Brown
Vipin Arora
Aileen L Pangan
Abbott Fund · USCharité - Universitätsmedizin Berlin · DEDélégation Paris 5 · FRLeiden University Medical Center · NLPrincess Alexandra Hospital · AUSwedish Medical Center · USUniversity of Alberta · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo evaluate the efficacy and safety of adalimumab in patients with non-radiographic axial spondyloarthritis (nr-axSpA).

methodsPatients fulfilled Assessment of Spondyloarthritis international Society (ASAS) criteria for axial spondyloarthritis, had a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of ≥ 4, total back pain score of ≥ 4 (10 cm visual analogue scale) and inadequate response, intolerance or contraindication to non-steroidal anti-inflammatory drugs (NSAIDs); patients fulfilling modified New York criteria for ankylosing spondylitis were excluded. Patients were randomised to adalimumab (N=91) or placebo (N=94). The primary endpoint was the percentage of patients achieving ASAS40 at week 12. Efficacy assessments included BASDAI and Ankylosing Spondylitis Disease Activity Score (ASDAS). MRI was performed at baseline and week 12 and scored using the Spondyloarthritis Research Consortium of Canada (SPARCC) index.

resultsSignificantly more patients in the adalimumab group achieved ASAS40 at week 12 compared with patients in the placebo group (36% vs 15%, p<0.001). Significant clinical improvements based on other ASAS responses, ASDAS and BASDAI were also detected at week 12 with adalimumab treatment, as were improvements in quality of life measures. Inflammation in the spine and sacroiliac joints on MRI significantly decreased after 12 weeks of adalimumab treatment. Shorter disease duration, younger age, elevated baseline C-reactive protein or higher SPARCC MRI sacroiliac joint scores were associated with better week 12 responses to adalimumab. The safety profile was consistent with what is known for adalimumab in ankylosing spondylitis and other diseases.

conclusionsIn patients with nr-axSpA, adalimumab treatment resulted in effective control of disease activity, decreased inflammation and improved quality of life compared with placebo. Results from ABILITY-1 suggest that adalimumab has a positive benefit-risk profile in active nr-axSpA patients with inadequate response to NSAIDs.

Indexed as

AdalimumabAdultAntibodies, Monoclonal, HumanizedAntirheumatic AgentsDouble-Blind MethodFemaleHumansMagnetic Resonance ImagingMaleMiddle AgedRadiographySacroiliac JointSpineSpondylarthritisTreatment OutcomeAdalimumabAntibodies, Monoclonal, HumanizedAntirheumatic Agents

Identifiers

PMID22772328
PMCPMC3664374
OpenAlexW2147791981

What OpenQuestion holds

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Read underepoch 390

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 OpenQuestion graph.