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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
* Drug interaction
A 66-year-old woman developed Pneumocystis jirovecii pneumonia (PCP) during treatment with etanercept, iguratimod, prednisolone and methotrexate for rheumatoid arthritis (RA). The co-administration of methotrexate and iguratimod could have lead to increased immunosuppression.
The woman, who had a history of rheumatoid arthritis for 13 years, was transferred to a hospital in November 2015, due to dry cough, fever and dyspnoea at rest for 1 week. Since 8 years, she had been receiving methotrexate 4 mg/week and prednisolone 2 mg/day, along with SC etanercept 50 mg/week since 4 years. However, in August 2015, the medications showed limited efficacy, owning to the addition of iguratimod 25 mg/day [not all the routes stated]. Her laboratory findings at presentation...
- Arita Y, et al. Pneumocystis jirovecii pneumonia developed in a patient with rheumatoid arthritis after 14 weeks of iguratimod add-on to treatment with methotrexate and etanercept. Modern rheumatology / the Japan Rheumatism Association 28: 1041-1043, No. 6, May 2018. Available from: URL: http://doi.org/10.1080/14397595.2016.1181026 - Japan