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Original Research

Risk of malignant lymphoma in patients with rheumatoid arthritis treated with biological disease-modifying antirheumatic drugs and methotrexate 

Ryo Inose, Kouichi Hosomi, Katsuyuki Takahashi, Satoshi Yokoyama, and Mitsutaka Takada

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Volume 57 (2019) p. 63 - 72

Abstract

Risk of malignant lymphoma in patients with rheumatoid arthritis treated with biological disease-modifying antirheumatic drugs and methotrexate 

Ryo Inose¹, Kouichi Hosomi², Katsuyuki Takahashi¹, Satoshi Yokoyama², and Mitsutaka Takada²

¹Department of Pharmacy, Osaka City University Hospital, and ²Division of Clinical Drug Informatics, School of Pharmacy, Kindai University, Osaka, Japan
Objective: This study investigated whether using biological disease-modifying antirheumatic drugs (bDMARDs) further increases the risk of malignant lymphoma in patients with rheumatoid arthritis undergoing methotrexate therapy using spontaneous adverse reaction databases in different countries. Materials and methods: Patient data were acquired from the US Food and Drug Administration’s Adverse Event Reporting System (FAERS), the Japanese Adverse Drug Event Report (JADER), and the Canada Vigilance Adverse Reaction Online Database (CVARD) from the first quarter of 2004 to the end of 2015. Data subset analysis was performed to investigate whether the use of bDMARDs further increased the risk of malignant lymphoma in patients receiving methotrexate therapy. Results: The FAERS subset data indicated a significant association between Hodgkin lymphoma and methotrexate with infliximab (reporting odds ratio (ROR): 8.28. 95% CI: 5.70 – 12.02; information component (IC): 2.04, 95% CI: 1.59 – 2.49). In addition, signal scores suggested that methotrexate with infliximab (ROR: 3.26. 95% CI: 2.68 – 3.98; IC: 1.31, 95% CI: 1.04 – 1.58) was significantly associated with non-Hodgkin lymphoma (NHL). The CVARD subset data also indicated a significant association between NHL and methotrexate with infliximab (ROR: 22.82. 95% CI: 5.02 – 103.78; IC: 1.77, 95% CI: 0.13 – 3.41). However, the JADER subset data revealed no significant associations. Conclusion: The present study shows that using infliximab further increases the risk of malignant lymphoma in patients receiving methotrexate therapy. Correspondence to:
Mitsutaka Takada, PhD
Division of Clinical Drug Informatics
Kindai University School of Pharmacy
3-4-1, Kowakae, Higashi-osaka, Osaka, 577-8502, Japan 
Email: takada@ phar.kindai.ac.jp

Original

Predictors of early discontinuation and therapeutic response to anamorelin in patients with cancer cachexia: A retrospective study 

Katsuyuki Takahashi, Minami Abe, Hirotake Yamase, Hideki Yoshino, Kayo Tsujii, Yuika Komatsu, Toru Otori, and Masahiko Kobayashi

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p. 0 - 10

Abstract

Katsuyuki Takahashi¹, Minami Abe¹, Hirotake Yamase², Hideki Yoshino², Kayo Tsujii², Yuika Komatsu¹, Toru Otori¹, and Masahiko Kobayashi²

¹Division of Social Pharmacy, Faculty of Pharmacy, Kindai University, and ²Department of Pharmacy, Japanese Red Cross Osaka Hospital, Osaka, Japan
Objective: Cancer cachexia is associated with poor tolerance to anticancer therapies and reduced survival rates. Anamorelin, a ghrelin receptor agonist, has been introduced for the management of cachexia; however, early discontinuation and variable therapeutic responses are frequently observed in clinical practice. We aimed to identify the real-world predictors of early discontinuation and therapeutic response to anamorelin. Materials and methods: We conducted a retrospective cohort study of 90 patients with cancer cachexia who received anamorelin therapy. Early discontinuation was defined as the cessation of treatment within 3 weeks. Therapeutic response was evaluated using changes in the modified Glasgow Prognostic Score (mGPS) in patients who continued treatment and had evaluable laboratory data. Nutritional and inflammatory indices, including the prognostic nutritional index (PNI), were assessed. Multivariate logistic regression analyses were performed to identify independent predictors. Results: 43 (47.8%) patients discontinued anamorelin treatment within 3 weeks. Multivariate analysis showed that high baseline white blood cell count, low baseline PNI, and gastrointestinal tumor type were independently associated with early discontinuation. Among 38 evaluable patients in the continuation group, 14 (36.8%) demonstrated improvement or stabilization of the mGPS. A high baseline PNI and the absence of concomitant nonsteroidal anti-inflammatory drug use were independently associated with a therapeutic response. Conclusion: Baseline nutritional and inflammatory statuses strongly influence both treatment continuation and response to anamorelin. The PNI is a practical predictor for identifying patients who are likely to benefit from therapy. Early intervention before severe nutritional deterioration may optimize the outcomes of patients with cancer cachexia. Correspondence to:
Katsuyuki Takahashi, PhD, Division of Social Pharmacy, Faculty of Pharmacy, Kindai University, Osaka, Japan, 3-4-1 Kowakae Higashi-Osaka, Osaka, 577-8502, Japan
Email: [email protected]

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