ArticleDrugs in R&D2015
Evaluation of the Safety and Effectiveness of Add-On Tacrolimus in Patients with Rheumatoid Arthritis Who Failed to Show an Adequate Response to Biological DMARDs: The Interim Results of a Specific Drug Use-Results Survey of Tacrolimus.
Article in Drugs in R&D, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed, 13 citations in OpenAlex.
- Article
- Safety of Tacrolimus in Autoimmune Disease: Results From Post-marketing Surveillance in South Korea.Journal of rheumatic diseases · 2021Review
- Sustained Long-Term Retention Rates of Abatacept in Combination with Conventional Synthetic Disease-Modifying Antirheumatic Drugs in Elderly Patients with Rheumatoid Arthritis.Medicina (Kaunas, Lithuania) · 2021Observational
Corrections and comments
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Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTacrolimus (TAC) is an immunosuppressive macrolide that blocks T-cell activation by specifically inhibiting calcineurin. TAC was approved in Japan for the treatment of rheumatoid arthritis (RA) in 2005. However, the safety and effectiveness of TAC adding on to biological disease-modifying anti-rheumatic drugs (DMARDs) in the real clinical setting may not be clear enough.
objectivesWe report here the interim results of post marketing surveillance (PMS) of TAC adding on to biological DMARDs in RA patients who failed to show an adequate response to biological DMARDs.
methodsPatients who had an inadequate response to biological DMARDs were enrolled. An inadequate response to biological DMARDs was defined as that all of the following conditions were met: a Simplified Disease Activity Index (SDAI) score of >3.3 when TAC was started; both the tender joint count and swollen joint count were the same or increased compared with those at 4-8 weeks prior to TAC; and biological DMARDs were used for at least 8 weeks prior to TAC. This study was conducted in compliance with the ministerial ordinance on "Good Post-Marketing Study Practice" (GPSP).
resultsThe safety data collection and evaluation for 172 patients and effectiveness data collection and evaluation for 165 patients were reported. The mean age was 61.9 years. Adverse drug reactions occurred in 18 patients. The mean SDAI decreased from 20.1 at baseline to 11.7 at week 24.
conclusionsTAC is well tolerated and effective when added on to biological DMARDs in RA patients who failed to achieve an adequate response to biological DMARDs.
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