Evidence map›Paper›PMID 38228361›Full record

Trial reportAnnals of the rheumatic diseases2024

Comparison of the effect of treatment with NSAIDs added to anti-TNF therapy versus anti-TNF therapy alone on the progression of structural damage in the spine over 2 years in patients with radiographic axial spondyloarthritis from the randomised-controlled CONSUL trial.

Fabian Proft, Murat Torgutalp, Burkhard Muche, Valeria Rios Rodriguez, Joachim Listing, Mikhail Protopopov, Judith Rademacher, Hildrun Haibel, Laura Spiller, Anne-Katrin Weber and 7 more

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Annals of the rheumatic diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
13.6field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 19 citations in OpenAlex.

  1. Trial
  2. Article
  3. Year in Review: Axial Spondyloarthritis.Mediterranean journal of rheumatology · 2026
    Review
  4. Review
  5. Article
  6. Article
  7. Review
  8. Article
  9. Article
  10. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 3 institutions in 1 country.

Fabian ProftDepartment of Gastroenterology, Infectiology and Rheumatology (including Nutrition Medicine), Charite Universitatsmedizin Berlin, Berlin, Germany Fabian.Proft@charite.de.ORCID http://orcid.org/0000-0003-4306-033X
Murat TorgutalpDepartment of Gastroenterology, Infectiology and Rheumatology (including Nutrition Medicine), Charite Universitatsmedizin Berlin, Berlin, Germany.ORCID http://orcid.org/0000-0003-4600-9484
Burkhard MucheDepartment of Gastroenterology, Infectiology and Rheumatology (including Nutrition Medicine), Charite Universitatsmedizin Berlin, Berlin, Germany.ORCID http://orcid.org/0000-0003-4104-5080
Valeria Rios RodriguezDepartment of Gastroenterology, Infectiology and Rheumatology (including Nutrition Medicine), Charite Universitatsmedizin Berlin, Berlin, Germany.ORCID http://orcid.org/0000-0001-5612-043X
Joachim ListingGerman Rheumatism Research Center Berlin, Berlin, Germany.
Mikhail ProtopopovDepartment of Gastroenterology, Infectiology and Rheumatology (including Nutrition Medicine), Charite Universitatsmedizin Berlin, Berlin, Germany.ORCID http://orcid.org/0000-0003-4840-5069
Judith RademacherDepartment of Gastroenterology, Infectiology and Rheumatology (including Nutrition Medicine), Charite Universitatsmedizin Berlin, Berlin, Germany.ORCID http://orcid.org/0000-0001-7442-2570
Hildrun HaibelDepartment of Gastroenterology, Infectiology and Rheumatology (including Nutrition Medicine), Charite Universitatsmedizin Berlin, Berlin, Germany.
Laura SpillerDepartment of Gastroenterology, Infectiology and Rheumatology (including Nutrition Medicine), Charite Universitatsmedizin Berlin, Berlin, Germany.
Anne-Katrin WeberDepartment of Gastroenterology, Infectiology and Rheumatology (including Nutrition Medicine), Charite Universitatsmedizin Berlin, Berlin, Germany.
Maryna VerbaDepartment of Gastroenterology, Infectiology and Rheumatology (including Nutrition Medicine), Charite Universitatsmedizin Berlin, Berlin, Germany.
Jan Brandt-JuergensRheumatology, Private Practice, Berlin, Germany.
Uta KiltzRheumazentrum Ruhrgebiet, Herne, Germany.ORCID http://orcid.org/0000-0001-5668-4497
Maren SieburgRheumatologische Facharztpraxis, Magdeburg, Germany.
Swen JackiRheumatologische Schwerpunktpraxis, Tübingen, Germany.
Joachim SieperDepartment of Gastroenterology, Infectiology and Rheumatology (including Nutrition Medicine), Charite Universitatsmedizin Berlin, Berlin, Germany.ORCID http://orcid.org/0000-0003-0285-9890
Denis PoddubnyyDepartment of Gastroenterology, Infectiology and Rheumatology (including Nutrition Medicine), Charite Universitatsmedizin Berlin, Berlin, Germany.ORCID http://orcid.org/0000-0002-4537-6015
Charité - Universitätsmedizin Berlin · DEGerman Rheumatism Research Centre · DERheumazentrum Ruhrgebiet · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe study aimed to evaluate the effect of adding a non-steroidal anti-inflammatory drug (NSAID), celecoxib (CEL), to a tumour necrosis factor inhibitor (TNFi), golimumab (GOL), compared with TNFi monotherapy on radiographic spinal progression in patients with radiographic axial spondyloarthritis (r-axSpA) over 2 years.

methodsR-axSpA patients, having risk factors for radiographic progression (high disease activity plus C reactive protein >5 mg/L and/or ≥1 syndesmophyte(s)), underwent a 12-week run-in phase with GOL 50 mg every 4 weeks. In the core phase (96 weeks), only patients with a good clinical response at week 12 were randomised (1:1) to GOL+CEL 200 mg two times per day (combination therapy) or GOL monotherapy. The primary endpoint was radiographic progression assessed by modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) change at week 108 in the intent-to-treat population.

resultsA total of 128 patients were enrolled in the run-in phase; and 109 patients were randomised at week 12 to monotherapy (n=55) or combination therapy (n=54). At week 108, 97 (52 vs 45) patients completed the study. The change in mSASSS at week 108 was 1.7 (95% CI 0.8 to 2.6) in the monotherapy vs 1.1 (95% CI 0.4 to 1.8) in the combination therapy groups (p=0.79). New syndesmophytes occurred in 25% of patients in the monotherapy vs 11% of patients in the combination therapy groups (p=0.12). During the study, no significant differences in adverse events and serious adverse events were observed between the groups.

conclusionsCombination therapy with GOL+CEL did not demonstrate statistically significant superiority over GOL monotherapy in retarding radiographic spinal progression over 2 years in r-axSpA.

Indexed as

SpondylarthropathiesSpondylitis, AnkylosingAnti-Inflammatory Agents, Non-SteroidalCelecoxibDisease ProgressionHumansRadiographySpineTumor Necrosis Factor InhibitorsAnti-Inflammatory Agents, Non-SteroidalCelecoxibTumor Necrosis Factor InhibitorsAnti-Inflammatory Agents, Non-SteroidalBiological TherapySpondylitis, AnkylosingTumor Necrosis Factor Inhibitors

Identifiers

PMID38228361
PMCPMC11041582
OpenAlexW4390908055

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.