| SHORT COMMUNICATION |
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| Year : 2016 | Volume
: 48
| Issue : 5 | Page : 591-594 |
Hepatic and hematological adverse effects of long-term low-dose methotrexate therapy in rheumatoid arthritis: An observational study
Lily Dubey1, Suparna Chatterjee1, Alakendu Ghosh2
1 Department of Pharmacology, Institute of Postgraduate Medical Education and Research and SSKM Hospital, Kolkata, West Bengal, India
2 Department of Rheumatology, Institute of Postgraduate Medical Education and Research and SSKM Hospital, Kolkata, West Bengal, India
Correspondence Address:
Dr. Lily Dubey
Department of Pharmacology, Institute of Postgraduate Medical Education and Research and SSKM Hospital, Kolkata, West Bengal
India
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/0253-7613.190761
Clinical trial registration CTRI/2015/05/005773
Objectives: Methotrexate (MTX) is the most commonly used cost-effective disease-modifying antirheumatoid drug (DMARD). Its main dose-limiting adverse effects are hepatic and hematopoietic. This cross-sectional, observational study evaluated the prevalence of hepatic and hematological adverse effects with long-term low-dose MTX therapy.
Materials and Methods: Rheumatoid arthritis (RA) patients taking ≤15 mg/week MTX for at least 2 years were enrolled from the rheumatology outpatient department. Demographic, disease, drug treatment profiles, and hematological and hepatic enzyme levels were noted.
Results: Of the 204 patients enrolled, the frequency of raised alanine transaminase level (≥3-fold rise above the upper limit of normal) was 6.37% (95% confidence interval of 3.76-10.59) including two biopsy-proven hepatic fibrosis cases. About 5.4% had severe anemia (<8 g/dl) and 4.4% had leukopenia.
Conclusion: Long-term low-dose MTX is safe in RA patients in the Indian population. The patterns of adverse effects were similar to those documented in earlier studies. However, our study results suggest that disease duration, cumulative MTX dose, concomitant DMARD intake are not risk factors associated with hepatic or hematological adverse effects.
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