Post-marketing surveillance of high-dose methotrexate (>8 mg/week) in Japanese patients with rheumatoid arthritis: A post hoc sub-analysis of patients according to duration of prior methotrexate use.

OBJECTIVES: To explore whether the duration of prior low-dose methotrexate treatment (MTX; ≤8 mg/week) influences the safety and effectiveness of high-dose MTX (>8 mg/week) in Japanese patients with rheumatoid arthritis (RA). METHODS: This post hoc sub-analysis of a Japanese post-marketing surveillance study evaluated patients initiating high-dose MTX with ≥1 year or <1 year prior low-dose MTX use. Over 24 or 52 weeks, adverse drug reactions (ADRs) were monitored, and effectiveness was assessed using the Disease Activity Score in 28 joints, erythrocyte sedimentation rate [DAS28-4 (ESR)]. RESULTS: One thousand two hundred and ninety-two MTX ≥1 year and 1001 MTX <1 year patients were included. The incidence of ADRs during the 24- and 52-week follow-up period was significantly more frequent in MTX <1 year than ≥1 year patients and serious ADRs were significantly higher in MTX <1 year than ≥1 year patients during the 52-week follow-up period (all p < .05). Over both follow-up periods, the mean DAS28-4 (ESR) significantly decreased from baseline for all groups. Remission and low disease activity rates (DAS28-4 (ESR) <2.6 and <3.2, respectively) increased from baseline for all groups. CONCLUSION: High-dose MTX reduced disease activity regardless of prior treatment duration, but ADRs occurred more frequently among MTX <1 year patients compared to MTX ≥1 year patients.

Reduction of prostate motion by removal of gas in rectum during radiotherapy.

PURPOSE: To evaluate the prostate and seminal vesicle motion in patients during both simulation and radiotherapy by rectal gas removal. METHODS AND MATERIALS: A total of 34 patients were treated in a whole pelvic radiotherapy (WPRT) arm and 42 patients in a non-WPRT arm. Of the 76 patients, 42 (26 in the non-WPRT arm and 16 in the WPRT arm) were instructed to insert their index finger and wash their rectums to evacuate their rectal gas. In addition to the planning computed tomography scan, three subsequent computed tomography scans were obtained during RT. The organs were outlined on each computed tomography image. Changes in the position of the prostate and seminal vesicles were analyzed using the center of mass (COM) coordinate system. The time trend, overall variations, systematic variations, and random variations were analyzed. RESULTS: The average cross-sectional area in the rectal gas removal group was significantly smaller than in all patients and in the WPRT arm. The vector of the prostate and seminal vesicle displacement for the rectal gas removal group was significantly smaller than in all patients. With rectal gas removal, the 95% confidence limit of the prostate displacement vector was reduced by 2.3 mm in the non-WPRT arm and 2.9 mm in the WPRT arm. The 95% confidence limit of the seminal vesicle displacement vector was reduced by 0.3 mm in the non-WPRT arm and 4.4 mm in the WPRT arm. CONCLUSIONS: Using rectal gas removal, the cross-sectional area could be decreased, resulting in reduced motion and margins for the prostate and seminal vesicles. This is especially important for WPRT patients who require RT to the prostate, seminal vesicles, and pelvic lymph nodes.