Evidence map›Paper›PMID 26917504›Full record

Trial reportBritish journal of clinical pharmacology2016

Pharmacokinetics, pharmacodynamics, short term efficacy and safety of RCT-18, a novel BLyS/APRIL fusion protein, in patients with rheumatoid arthritis.

Xia Chen, Qian Zhao, Yong Hou, Ji Jiang, Wen Zhong, Wenxiang Wang, Xuejing Yao, Lin Li, Jianmin Fang, Fengchun Zhang and 1 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in British journal of clinical pharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
–field-weighted citation impact
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

18 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Telitacicept as a New Therapeutic Avenue for Generalized Myasthenia Gravis and Thymoma-Associated Myasthenia Gravis.Journal of neuroimmune pharmacology : the official journal of the Society on NeuroImmune Pharmacology · 2026
    Article
  7. Article
  8. Article
  9. Article
  10. Review
  11. Article
  12. Review
  13. Article
  14. Role of telitacicept in the treatment of IgA nephropathy.European journal of medical research · 2023
    Review
  15. Telitacicept for autoimmune nephropathy.Frontiers in immunology · 2023
    Review
  16. Review
  17. Hydrogen Sulfide: a Novel Immunoinflammatory Regulator in Rheumatoid Arthritis.Advances in experimental medicine and biology · 2021
    Review
  18. 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.

Xia ChenClinical Pharmacology Research Center, Peking Union Medical College Hospital, Beijing.
Qian ZhaoClinical Pharmacology Research Center, Peking Union Medical College Hospital, Beijing.
Yong HouClinical Pharmacology Research Center, Peking Union Medical College Hospital, Beijing.
Ji JiangClinical Pharmacology Research Center, Peking Union Medical College Hospital, Beijing.
Wen ZhongClinical Pharmacology Research Center, Peking Union Medical College Hospital, Beijing.
Wenxiang WangRC Biotechnologies, Ltd., Yantai.
Xuejing YaoRC Biotechnologies, Ltd., Yantai.
Lin LiRC Biotechnologies, Ltd., Yantai.
Jianmin FangSchool of Life Science and Technology, Tongji University, Shanghai, China.
Fengchun ZhangDepartment of Rheumatology, Peking Union Medical College Hospital, Beijing.
Pei HuClinical Pharmacology Research Center, Peking Union Medical College Hospital, Beijing.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimRCT-18 is a recombinant fusion protein that interferes with the selection and survival of mature B-lymphocytes by inhibiting B-lymphocyte stimulator and a proliferation-inducing ligand.

methodsThis single blind, randomized, placebo controlled, clinical pharmacological study explored the short term efficacy and safety of RCT-18 in 21 rheumatoid arthritis (RA) patients with three different dosing regimens. The pharmacological behaviour of RCT-18 was also characterized through a six level biomarker cascade approach to identify potential predictors for clinical responses.

resultsNine out of 10 patients (>80%) experienced moderate to good EULAR response at the end of 3 months with once or twice weekly doses of 180 mg RCT-18, whereas weekly administration of 360 mg RCT-18 or placebo, however, only resulted in moderate improvement in one patient in each group. Absence of IgM-type rheumatoid factor reduction, recovery of IgM 2 weeks after drug cessation, lack of decrease in the count of CD27(+) B-lymphocytes and a DAS28 change from baseline <6 in 4-6 weeks after the treatment initiation may indicate poor clinical response. No anti-drug antibody of RCT-18 was detected. The active treatments were well tolerated, although more mild to moderate infections were reported in patients receiving RCT-18.

conclusionThe study results support further development of RCT-18 in RA patients and provide important information for future dose selection.

Indexed as

AdultAntirheumatic AgentsArthritis, RheumatoidBiomarkersB-LymphocytesDose-Response Relationship, DrugFemaleHumansImmunoglobulin Fc FragmentsImmunoglobulin MMaleMiddle AgedRecombinant Fusion ProteinsSingle-Blind MethodTime FactorsTransmembrane Activator and CAML Interactor ProteinAntirheumatic AgentsBiomarkersImmunoglobulin Fc FragmentsImmunoglobulin MRCT-18 fusion proteinRecombinant Fusion ProteinsTransmembrane Activator and CAML Interactor Proteinefficacyimmunogenicitypharmacodynamicspharmacokineticsrheumatoid arthritissafety

Identifiers

PMID26917504
PMCPMC4917793

What OpenQuestion holds

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Registered trials

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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.