Evidence map›Paper›PMID 34344706›Full record

Trial reportAnnals of the rheumatic diseases2022

Olokizumab, a monoclonal antibody against interleukin 6, in combination with methotrexate in patients with rheumatoid arthritis inadequately controlled by methotrexate: efficacy and safety results of a randomised controlled phase III study.

Evgeniy Nasonov, Saeed Fatenejad, Eugen Feist, Mariana Ivanova, Elena Korneva, Diana G Krechikova, Aleksey L Maslyanskiy, Mikhail Samsonov, Rumen Stoilov, Elena V Zonova and 1 more

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Annals of the rheumatic diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 3 pooled it
8.7field-weighted citation impact, top 2% 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

29 citing papers in PubMed, 3 syntheses or guidelines pooled it, 67 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Article
  10. Review
  11. Article
  12. Article
  13. Article
  14. Review
  15. Review
  16. Review
  17. Article
  18. Review
  19. Article
  20. 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

11 authors at 7 institutions in 3 countries.

Evgeniy NasonovResearch Institute of Rheumatology of RAMS, Moskva, Russian Federation.ORCID 0000-0002-1598-8360
Saeed FatenejadSFC Medica, Charlotte, North Carolina, USA.ORCID 0000-0002-3005-9439
Eugen FeistDepartment for Rheumatology, HELIOS Specialist Hospital Vogelsang/Gommern Clinic for Rheumatology, Gommern, Germany.ORCID 0000-0002-9872-5282
Mariana IvanovaUniversity Hospital St Ivan Rilski Rheumatology Clinic, Sofia, Bulgaria.ORCID 0000-0002-0441-3043
Elena KornevaMedical, CJSC R-Pharm, Moskow, Russian Federation.ORCID 0000-0002-4085-5869
Diana G KrechikovaNon-state Healthcare Institution Regional Clinical Hospital at Smolensk Station, Smolensk, Russian Federation.ORCID 0000-0003-1207-6144
Aleksey L MaslyanskiyMedical Research Centre, Federal Almazov North West Medical Research Centre, Saint-Petersburg, Russian Federation.ORCID 0000-0003-2427-4148
Mikhail SamsonovMedical, CJSC R-Pharm, Moskow, Russian Federation.
Rumen StoilovUniversity Hospital St Ivan Rilski Rheumatology Clinic, Sofia, Bulgaria.ORCID 0000-0002-6340-9650
Elena V ZonovaNovosibirsk State Medical University, Novosibirsk, Russian Federation.
Mark GenoveseDivision of Immunology and Rheumatology, Stanford University, Stanford, California, USA genovese@stanford.edu.ORCID 0000-0001-5294-4503
R-Pharm (Russia) · RUUniversity Hospital St. Ivan Rilski · BGCarolinas Medical Center · USFederal Almazov North-West Medical Research Centre · RUHospital at Smolensk Station · RUNovosibirsk State Medical University · RUStanford University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the efficacy and safety of olokizumab (OKZ) in patients with active rheumatoid arthritis despite treatment with methotrexate (MTX).

methodsIn this 24-week multicentre, placebo-controlled, double-blind study, patients were randomised 1:1:1 to receive subcutaneously administered OKZ 64 mg once every 2 weeks, OKZ 64 mg once every 4 weeks, or placebo plus MTX. The primary efficacy endpoint was the proportion of patients achieving an American College of Rheumatology 20% (ACR20) response at week 12. The secondary efficacy endpoints included percentage of subjects achieving Disease Activity Score 28-joint count based on C reactive protein <3.2, Health Assessment Questionnaire Disability Index at week 12, ACR50 response and Clinical Disease Activity Index ≤2.8 at week 24. Safety and immunogenicity were assessed throughout the study.

resultsA total of 428 patients were randomised. ACR20 responses were more frequent with OKZ every 2 weeks (63.6%) and OKZ every 4 weeks (70.4%) than placebo (25.9%) (p<0.0001 for both comparisons). There were significant differences in all secondary efficacy endpoints between OKZ-treated arms and placebo. Treatment-emergent serious adverse events (TESAEs) were reported by more patients in the OKZ groups compared with placebo. Infections were the most common TESAEs. No subjects developed neutralising antidrug antibodies.

conclusionsTreatment with OKZ was associated with significant improvement in signs, symptoms and physical function of rheumatoid arthritis without discernible differences between the two regimens. Safety was as expected for this class of agents. Low immunogenicity was observed.

Indexed as

Antirheumatic AgentsArthritis, RheumatoidAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedDouble-Blind MethodDrug Therapy, CombinationHumansInterleukin-6MethotrexateTreatment OutcomeAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntirheumatic AgentsInterleukin-6Methotrexateolokizumabantirheumatic agentsarthritiscytokinesrheumatoid

Identifiers

PMID34344706
PMCPMC8921576
OpenAlexW3191857239

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.