Showing papers by "Shigeki Momohara published in 2018"
TL;DR: GLM showed effectiveness in Japanese rheumatoid arthritis patients with an acceptable safety profile and concomitant MTX use was associated with higher probability of continuing therapy.
Abstract: Objectives: The purpose of this study was to evaluate the real-world safety and effectiveness of golimumab (GLM) in Japanese patients with rheumatoid arthritis.Methods: A postmarketing surveillance...
27 citations
TL;DR: MTX and glucocorticoid use and doses in daily practice in rheumatoid arthritis patients were commonly reduced after the initiation of bDMARDs, with the dose adjustment varied depending on the b DMARD.
Abstract: Objectives: To evaluate usage patterns for methotrexate (MTX) and/or glucocorticoids in rheumatoid arthritis (RA) patients receiving biological disease-modifying antirheumatic drugs (bDMARDs) in da...
14 citations
TL;DR: To achieve physical activity goal, patients with rheumatoid arthritis should control pain VAS, and HAQ-DI to preserve activities of daily living in patients with RA.
Abstract: Objectives: We aimed to identify the relationship between achievement of a physical activity goal and the characteristics of patients with rheumatoid arthritis (RA).Methods: Overall, 137 patients w...
9 citations
TL;DR: This IA of tofacitinib PMS in Japan did not reveal any new or unexpected safety signals vs the tofacItinib RA clinical trials and the SIE IR was within the range reported in PMS of biologic treatments.
Abstract: Background Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Efficacy and safety of tofacitinib have been shown in patients (pts) with RA in global Phase (P)2, P3 and a long-term extension (LTE) study and in 2 P2 and 1 LTE study in Japanese pts. Objectives To evaluate safety of tofacitinib following drug approval in Japanese pts with RA using all-case post-marketing surveillance (PMS) data. Methods An interim analysis (IA) of safety data from an ongoing 3 year PMS study was conducted (5 Nov 2017 data-cut). All Japanese RA pts receiving tofacitinib were prospectively registered in the PMS study. All adverse events (AEs) were collected during tofacitinib treatment. Follow-up surveillance after discontinuation was conducted for serious infection events (SIEs; 1 year), malignancy and death (3 years). For all AEs and serious AEs, 6 month IA data was used. For AEs of special interest, all-period data (up to 36 months) was used to calculate cumulative incidence rates (IRs: pts with events/100 pt-years [yrs]) over time for herpes zoster (HZ) and SIEs during treatment +28 days and for malignancies during the full observation period. Results Overall, 3929 tofacitinib-treated pts with 1704.1 pt-yrs of exposure were included in the 6 month IA of safety: 80.5% were female, mean age was 62.7 years, with 32.6% of pts≥70 years. Of these, 892 pts (22.7%) discontinued treatment, mainly due to AEs (351 pts; 8.9%) or lack of effectiveness (335 pts; 8.5%). At least one AE was observed in 1313 pts (33.4%); infections were observed in 493 pts (12.5%). The most frequent AEs were HZ (145 pts; 3.7%) and abnormal hepatic function (72 pts; 1.8%). SAEs occurred in 287 pts (7.3%); the most frequent SAEs were HZ (24 pts; 0.6%) and pneumonia/bacterial pneumonia (33 pts; 0.8%). SIEs occurred in 130 pts (3.3%). Malignancy (all causality) was reported in 25 pts (0.6%); lymphoma/lymphoproliferative disorder occurred in 5 pts (0.1%) and breast cancer in 3 pts (0.08%). There were 21 deaths (0.5%) during the 6 month period. The most common causes of death (including pts with multiple causes listed) were infection (6 cases) and malignancy (5 cases). For AEs of special interest from all-period data the IR of HZ (serious and non-serious) was 6.81 (264 pts; 3876 pt-yrs), the IR of SIEs was 5.38 (212 pts; 3941 pt-yrs) and the IR of malignancy was 1.25 (61 pts; 4874 pt-yrs). Conclusions This IA of tofacitinib PMS in Japan did not reveal any new or unexpected safety signals vs the tofacitinib RA clinical trials. IRs for HZ and malignancy were similar to IRs in clinical trials of tofacitinib in Japanese RA pts and the SIE IR was within the range reported in PMS of biologic treatments. Continuous monitoring of SAEs is required until the final PMS results. Acknowledgements Study sponsored by Pfizer Inc. Medical writing support was provided by A MacLachlan of CMC and funded by Pfizer Inc. Disclosure of Interest N. Tamura Grant/research support from: AbbVie, Astellas, Bristol-Myers Squibb, Chugai, Eisai, Janssen, Mitsubishi-Tanabe, Takeda, Speakers bureau: AbbVie, Astellas, Bristol-Myers Squibb, Eisai, Janssen, Mitsubishi-Tanabe, M. Kuwana Grant/research support from: Ayumi, Chugai, Eisai, Mitsubishi-Tanabe, Ono, Pfizer Inc, Speakers bureau: Astellas, Chugai, Eisai, Janssen, Mitsubishi-Tanabe, Ono, Pfizer Inc, UCB, T. Atsumi Grant/research support from: Alexion, Astellas, Bristol-Myers Squibb, Chugai, Eisai, Janssen, Mitsubishi-Tanabe, Sanofi Scholarship donations from: Bayer, Daiichi-Sankyo, Takeda, Speakers bureau: AbbVie, Astellas, Chugai, Eisai, Mitsubishi-Tanabe, Takeda, Pfizer Inc, UCB Japan, S. Takei Grant/research support from: Chugai, Eisai, Mitsubishi-Tanabe, Takeda, Speakers bureau: Asahi-kasei, Ayumi, Chugai, Mitsubishi-Tanabe, Ono, M. Harigai Grant/research support from: Eisai, Takeda, Teijin, Consultant for: AbbVie, Ayumi, Bristol-Myers Squibb, Chugai, Janssen, Pfizer Inc, Paid instructor for: Takeda, T. Fujii Shareholder of: AbbVie, Ayumi, Bristol-Myers Squibb, Chugai, Janssen, Eisai, Mitsubishi-Tanabe, Ono, Grant/research support from: Eisai, Mitsubishi-Tanabe, Ono, Daiichi-Sankyo, Pfizer Japan Inc, Speakers bureau: AbbVie, Mitsubishi-Tanabe, Ono, Pfizer Japan Inc., H. Matsuno Consultant for: Ayumi, Meiji Seika, Mochida, Nichi-Iko, T. Mimori Grant/research support from: Astellas, Ayumi, Chugai, Daiichi-Sankyo, Eisai, MSD, Mitsubishi-Tanabe, Sanofi, Taisho Toyama, Speakers bureau: Astellas, Bristol-Myers Squibb, Chugai, Eisai, Mitsubishi-Tanabe, S. Momohara Speakers bureau: AbbVie, Bristol-Myers Squibb, Eisai, Janssen, Pfizer Japan Inc, Ono, Takeda, Mitsubishi-Tanabe, K. Yamamoto Grant/research support from: AbbVie, Astellas, Ayumi, Chugai, Eisai, Mitsubishi-Tanabe, Nippon Kayaku, Pfizer Inc, Takeda, Taisho Toyama, UCB, Teijin, Speakers bureau: Asahi-kasei, AstraZeneca, Ayumi, Boehringer Ingelheim, Bristol-Myers Squibb, Chugai, Eisai, Janssen, UCB, Mitsubishi-Tanabe, Pfizer Inc, Sanofi, Sumitomo Dainippon, Taisho-Toyama, Takeda, Teijin, K. Nomura Employee of: Pfizer Japan Inc, Y. Endo Employee of: Pfizer Japan Inc, N. Sugiyama Employee of: Pfizer Japan Inc, T. Hirose Employee of: Pfizer Japan Inc, Y. Morishima Employee of: Pfizer Japan Inc, N. Yoshii Employee of: Pfizer Japan Inc, M. Takagi Grant/research support from: Kaken, Taisho-Toyama, Eizai, Hisamitsu, Chugai, Pfizer Inc, Kyocera, Nihon Zoki, MSD, Astellas, AbbVie, Daiichi-Sankyo, Teijin, Takeda, Mitsubishi-Tanabe, Shionogi
7 citations
TL;DR: TCZ treatment in patients with RA may increase the risk of blood loss after TKA because of decreased fibrinogen levels, according to the Nadler formula.
Abstract: Objective: Since IL-6 has been associated with activation of the coagulation cascade and upregulation of fibrinogen transcription, we retrospectively tested the hypothesis that patients with rheumatoid arthritis (RA) treated with tocilizumab (TCZ) may lose more blood when undergoing total knee arthroplasty (TKA).Methods: This study included 115 RA patients who underwent primary TKA and were preoperatively tested for fibrinogen levels. The blood volume of each patient was calculated using the Nadler formula, and estimated blood loss after TKA was calculated as the change between pre-operative and post-operative hematocrits. If salvaged blood was reinfused, the volume was measured and added to the volume of the estimated blood loss.Results: We observed that patients treated with TCZ had significantly lower pre-operative fibrinogen levels than those not treated with TCZ (190.0 mg/dL versus 347.0 mg/dL, respectively; p = .00018). We also observed a statistically significant increase in mean total volu...
5 citations
TL;DR: This study divided the consecutive patients into two groups and indicated that abatacept for RA treatment was effective for 104 weeks, and clinically analyzed the change in disease activity from baseline by Mann–Whitney U-test.
Abstract: To the Editor,Abatacept is a biologic agent for treating rheumatoid arthritis (RA). It inhibits T-cell activation by binding to CD80/86 and modulating its interaction with CD28. In a postmarketing ...
2 citations
TL;DR: This case of necrotizing fasciitis in a patient with rheumatoid arthritis treated with abatacept highlights the need for suspicion of severe bacterial infection for early diagnosis and effective treatment.
Abstract: Herein, we present a case of necrotizing fasciitis (NF) in a patient with rheumatoid arthritis (RA) treated with abatacept. Cultures of the patient's leg effusion revealed group A Streptococcus. Treatment included antibiological drugs, repeat debridement, negative pressure wound therapy (NPWT), and skin grafting. This case highlights the need for suspicion of severe bacterial infection for early diagnosis and effective treatment. NF with RA can be treated effectively with repeat debridement and NPWT.
TL;DR: Compared with csDMARDs and/or steroid without ABT, adding ABT to the treatment does not appear to increase the incidence rates of postoperative adverse events in rheumatoid arthritis patients undergoing orthopaedic surgery.
Abstract: Background: Abatacept (ABT) is clinically used as the only T-cell modifier available for rheumatoid arthritis treatment and has shown similar efficacy as tumour necrosis factor inhibitors and a safer profile, especially a lower infection ratio in registry data. Latourte et al. recently published the results of perioperative complications of orthopaedic and other types of surgery in patients using ABT. However, they did not compare the complication rates with those in patients who received csDMARDs. It remains unknown whether ABT is associated with more postoperative complications than conventional synthetic DMARDs (csDMARDs). Objectives: The aims of this study were to investigate whether ABT is associated with more adverse events after orthopaedic surgery compared with csDMARDs and, if so, to identify significant risk factors for those events. Methods: A retrospective multicenter nested case–control study was performed in 18 institutions. Patients receiving ABT were matched individually with patients receiving csDMARDs and/or steroid. Serious adverse events were defined as surgical site infection, delayed wound healing, deep vein thrombosis or pulmonary embolism, flare-up, serious infection in other organs. The incidence rates of serious adverse events in both groups were compared with Mantel-Haenzel test. Risk factors for serious adverse events in the ABT group were analyzed by logistic regression model. Results: A total of 3358 cases were collected. After inclusion and exclusion, 2651 patients were selected for matching, and 194 patients in 97 pairs were chosen for subsequent comparative analyses between the ABT and control groups. No between-group differences were detected in the incidence rates of each adverse event or in the combined incidence rate of adverse events. The odds ratio of the history of serious infection for serious adverse events was 12.6 (95%CI 1.12–141, P=0.04) in patients who received ABT and underwent orthopaedic surgery. Conclusions: Compared with csDMARDs and/or steroid without ABT, adding ABT to the treatment does not appear to increase the incidence rates of postoperative adverse events in rheumatoid arthritis patients undergoing orthopaedic surgery. A history of serious infection is a significant risk factor for both infection and other serious adverse events, and such patients should be treated with particular caution. Reference [1]Latourte A, et al. Safety of surgery in patients with rheumatoid arthritis treated by abatacept: data from the French Orencia in Rheumatoid Arthritis Registry. Rheumatology (Oxford)2017Apr 1;56(4):629–637. Disclosure of Interest: H. Ito Grant/research support from: BMS, ONO Pharmaceutical, S. Tsuji: None declared, M. Nakayama: None declared, Y. Mochida: None declared, K. Nishida: None declared, H. Ishikawa: None declared, T. Kojima: None declared, T. Matsumoto: None declared, A. Kubota: None declared, T. Mochizuki: None declared, K. Sakuraba: None declared, I. Matsushita: None declared, A. Nakajima: None declared, R. Hara: None declared, A. Haraguchi: None declared, T. Matsubara: None declared, K. Kanbe: None declared, N. Nakagawa: None declared, M. Haraguchi: None declared, S. Momohara: None declared