Ayako Nakajima

Mie University Hospital

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Ayako Nakajima has a total of 141 co-authors. Here are the top co-authors by number of shared publications:

Atsuo Taniguchi
Institute of Rheumatology, Tokyo Women’s Medical University, Tokyo, Japan
5 shared publications
Eisuke Inoue
Department of Rheumatology, Tokyo Women’s Medical University School of Medicine, Tokyo, Japan
5 shared publications
Hisashi Yamanaka
Sanno Medical Center, Tokyo, Japan
5 shared publications
Eiichi Tanaka
Division of Rheumatology, Department of Internal Medicine, Tokyo Women’s Medical University School of Medicine , Tokyo
4 shared publications
Kumi Shidara
Institute of Rheumatology, Tokyo Women's Medical University, 10-22 Kawada-cho, Shinjuku-ku, Tokyo, 162-0054, Japan
4 shared publications
Masayoshi Harigai
Department of Rheumatology, International University of Health and Welfare School of Medicine, Chiba, Japan
4 shared publications

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Cited by 8
- 5 June 2025
- Published by Elsevier in Respiratory Investigation
Evaluation and management of rheumatoid arthritis-associated interstitial lung disease
by Yuhei Ito, Yoshiyuki Arinuma, Ayako Nakajima
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- 5 June 2025
- Published by Elsevier in Respiratory Investigation
Open Access
Evaluation and management of rheumatoid arthritis-associated interstitial lung disease
by Yuhei Ito, Yoshiyuki Arinuma, Ayako Nakajima
Cited by 8
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Cited by 9
- 7 March 2025
- Published by Oxford University Press (OUP) in Modern Rheumatology
Three-year safety and effectiveness of tofacitinib in patients with rheumatoid arthritis in Japan: Final analysis of an all-case postmarketing surveillance study
by Masataka Kuwana, Naonobu Sugiyama, Shigeki Momohara, Tatsuya Atsumi, Syuji Takei, Naoto Tamura, Masayoshi Harigai, Takao Fujii, Hiroaki Matsuno, Kazuhiko Yamamoto, et al.
Objective: To evaluate tofacitinib real-world safety/effectiveness in patients with rheumatoid arthritis (RA) in Japan in a 3-year all-case postmarketing surveillance study. Methods: All patients with RA who initiated tofacitinib (30 July 2013–03 December 2017) were registered in Japan. Serious infections/malignancy/mortality incidences were compared in patients with active RA after >8 mg methotrexate/week for ≥3 months who received tofacitinib or other drugs (control: methotrexate/other disease-modifying antirheumatic drugs/immunosuppressants). Disease activity was assessed over 3 years. Results: The adherent comparative safety analysis set included 3731/2419 (tofacitinib/control) patients. Baseline (tofacitinib/control) biologic disease-modifying antirheumatic drug history (53.3%/12.2%), methotrexate history (81.4%/98.6%), and RA stage (I–II: 45.3%/67.1%) and class (1–2: 76.5%/90.8%) varied between groups. For tofacitinib vs control, incidence rates [patients with event/100 patient-years (95% confidence interval)] were 6.86 (5.96–7.86) vs 1.42 (0.97–2.00) for serious infections (adjusted hazard ratios 3.25–3.80); 1.40 (1.18–1.66) vs 0.88 (0.66–1.15) for malignancies (adjusted hazard ratios 1.37–1.53); 0.89 (0.72–1.10) vs 0.26 (0.15–0.43) for mortality (unadjusted hazard ratio 3.29). Remission/low disease activity rates with tofacitinib increased over 3 years. Conclusions: Serious infection rates were higher, and malignancy rates were numerically higher with tofacitinib vs control. Results should be interpreted cautiously due to imbalanced groups and unmeasured confounders.
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- 7 March 2025
- Published by Oxford University Press (OUP) in Modern Rheumatology
Open Access
Three-year safety and effectiveness of tofacitinib in patients with rheumatoid arthritis in Japan: Final analysis of an all-case postmarketing surveillance study
by Masataka Kuwana, Naonobu Sugiyama, Shigeki Momohara, Tatsuya Atsumi, Syuji Takei, Naoto Tamura, Masayoshi Harigai, Takao Fujii, Hiroaki Matsuno, Kazuhiko Yamamoto, et al.
Objective: To evaluate tofacitinib real-world safety/effectiveness in patients with rheumatoid arthritis (RA) in Japan in a 3-year all-case postmarketing surveillance study. Methods: All patients with RA who initiated tofacitinib (30 July 2013–03 December 2017) were registered in Japan. Serious infections/malignancy/mortality incidences were compared in patients with active RA after >8 mg methotrexate/week for ≥3 months who received tofacitinib or other drugs (control: methotrexate/other disease-modifying antirheumatic drugs/immunosuppressants). Disease activity was assessed over 3 years. Results: The adherent comparative safety analysis set included 3731/2419 (tofacitinib/control) patients. Baseline (tofacitinib/control) biologic disease-modifying antirheumatic drug history (53.3%/12.2%), methotrexate history (81.4%/98.6%), and RA stage (I–II: 45.3%/67.1%) and class (1–2: 76.5%/90.8%) varied between groups. For tofacitinib vs control, incidence rates [patients with event/100 patient-years (95% confidence interval)] were 6.86 (5.96–7.86) vs 1.42 (0.97–2.00) for serious infections (adjusted hazard ratios 3.25–3.80); 1.40 (1.18–1.66) vs 0.88 (0.66–1.15) for malignancies (adjusted hazard ratios 1.37–1.53); 0.89 (0.72–1.10) vs 0.26 (0.15–0.43) for mortality (unadjusted hazard ratio 3.29). Remission/low disease activity rates with tofacitinib increased over 3 years. Conclusions: Serious infection rates were higher, and malignancy rates were numerically higher with tofacitinib vs control. Results should be interpreted cautiously due to imbalanced groups and unmeasured confounders.
Cited by 9
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Cited by 6
- 13 September 2024
- Published by Oxford University Press (OUP) in Rheumatology
Novel deep-learning analysis for connective tissue disease—related interstitial lung disease extent assessment on CT: a preliminary cross-sectional study
by Yuhei Ito, Yasutaka Ichikawa, Shuichi Murashima, Hajime Sakuma, Tae Iwasawa, Yoshiyuki Arinuma, Ayako Nakajima
Physician’s evaluation of interstitial lung disease (ILD) extension with high-resolution computed tomography (HRCT) has limitations such as lack of objectivity and reproducibility. This study aimed to investigate the utility of computer-based deep-learning analysis using QZIP-ILD® software (DL-QZIP) compared with conventional approaches in connective tissue disease (CTD) -related ILD. Patients with CTD–ILD visiting our Rheumatology Centre between December 2020 and April 2024 were recruited. Quantitative scores, including the percentage of lung involvement in ground-glass opacity (QGG), total fibrotic lesion (QFIB), and overall ILD extension encompassing both QGG and QFIB (QILD), calculated by DL-QZIP, were compared with semiquantitative visual method, employing intraclass correlation coefficients (ICC). We compared the capability of QILD scores to distinguish patients with forced vital capacity (FVC) % p < 0.01). QZIP-ILD® demonstrates superior capability in distinguishing patients with a radiological scenario correlated to severe physiological impairment, while showing relatively good correlations in quantifying the extent on HRCT compared with conventional method in CTD–ILD.
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- 13 September 2024
- Published by Oxford University Press (OUP) in Rheumatology
Novel deep-learning analysis for connective tissue disease—related interstitial lung disease extent assessment on CT: a preliminary cross-sectional study
by Yuhei Ito, Yasutaka Ichikawa, Shuichi Murashima, Hajime Sakuma, Tae Iwasawa, Yoshiyuki Arinuma, Ayako Nakajima
Physician’s evaluation of interstitial lung disease (ILD) extension with high-resolution computed tomography (HRCT) has limitations such as lack of objectivity and reproducibility. This study aimed to investigate the utility of computer-based deep-learning analysis using QZIP-ILD® software (DL-QZIP) compared with conventional approaches in connective tissue disease (CTD) -related ILD. Patients with CTD–ILD visiting our Rheumatology Centre between December 2020 and April 2024 were recruited. Quantitative scores, including the percentage of lung involvement in ground-glass opacity (QGG), total fibrotic lesion (QFIB), and overall ILD extension encompassing both QGG and QFIB (QILD), calculated by DL-QZIP, were compared with semiquantitative visual method, employing intraclass correlation coefficients (ICC). We compared the capability of QILD scores to distinguish patients with forced vital capacity (FVC) % p < 0.01). QZIP-ILD® demonstrates superior capability in distinguishing patients with a radiological scenario correlated to severe physiological impairment, while showing relatively good correlations in quantifying the extent on HRCT compared with conventional method in CTD–ILD.
Cited by 6
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Cited by 17
- 9 August 2024
- Published by Oxford University Press (OUP) in Modern Rheumatology
Safety of baricitinib in Japanese patients with rheumatoid arthritis in clinical use: 3-year data of all-case postmarketing surveillance study
by Nami Okamoto, Tatsuya Atsumi, Michiaki Takagi, Nobunori Takahashi, Tsutomu Takeuchi, Naoto Tamura, Atsuo Nakajima, Ayako Nakajima, Takao Fujii, Hiroaki Matsuno, et al.
To assess safety of baricitinib in Japanese patients with rheumatoid arthritis in real-world clinical practice. This all-case post-marketing surveillance study included patients initiating baricitinib for rheumatoid arthritis from September 2017 to April 2019. Treatment duration was recorded. Safety data were collected for up to 3 years from baricitinib initiation (up to 4 weeks post discontinuation in discontinuing patients). Safety analyses included 4720 patients; 2580 (54.7%) were ≥65 years old. Baricitinib persistence rate was 45.4% (3 year Kaplan-Meier analysis); the most common discontinuation reason was insufficient effectiveness (n = 1005, 21.3%). Serious adverse events occurred in 600 patients (incidence rate 10.42/100 patient-years; 95% confidence interval, 9.76–11.09). There were 39 deaths (incidence rate 0.43 [0.30–0.57]/100 patient-years). Incidence rate per 100 patient-years for adverse events of special interest were herpes zoster 4.68 (4.22–5.14), serious infection 3.05 (2.68–3.41), malignancy 1.09 (0.87–1.30), major adverse cardiovascular events 0.35 (0.23–0.48) and venous thromboembolism 0.25 (0.15–0.36). Incidence rates did not increase with prolonged exposure. No new safety concerns were identified during this 3 year post-marketing surveillance study of baricitinib in Japanese patients with rheumatoid arthritis. Patients and clinicians should be cognizant of herpes zoster and other serious infection risks during baricitinib treatment, especially in the first 6 months.
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- 9 August 2024
- Published by Oxford University Press (OUP) in Modern Rheumatology
Open Access
Safety of baricitinib in Japanese patients with rheumatoid arthritis in clinical use: 3-year data of all-case postmarketing surveillance study
by Nami Okamoto, Tatsuya Atsumi, Michiaki Takagi, Nobunori Takahashi, Tsutomu Takeuchi, Naoto Tamura, Atsuo Nakajima, Ayako Nakajima, Takao Fujii, Hiroaki Matsuno, et al.
To assess safety of baricitinib in Japanese patients with rheumatoid arthritis in real-world clinical practice. This all-case post-marketing surveillance study included patients initiating baricitinib for rheumatoid arthritis from September 2017 to April 2019. Treatment duration was recorded. Safety data were collected for up to 3 years from baricitinib initiation (up to 4 weeks post discontinuation in discontinuing patients). Safety analyses included 4720 patients; 2580 (54.7%) were ≥65 years old. Baricitinib persistence rate was 45.4% (3 year Kaplan-Meier analysis); the most common discontinuation reason was insufficient effectiveness (n = 1005, 21.3%). Serious adverse events occurred in 600 patients (incidence rate 10.42/100 patient-years; 95% confidence interval, 9.76–11.09). There were 39 deaths (incidence rate 0.43 [0.30–0.57]/100 patient-years). Incidence rate per 100 patient-years for adverse events of special interest were herpes zoster 4.68 (4.22–5.14), serious infection 3.05 (2.68–3.41), malignancy 1.09 (0.87–1.30), major adverse cardiovascular events 0.35 (0.23–0.48) and venous thromboembolism 0.25 (0.15–0.36). Incidence rates did not increase with prolonged exposure. No new safety concerns were identified during this 3 year post-marketing surveillance study of baricitinib in Japanese patients with rheumatoid arthritis. Patients and clinicians should be cognizant of herpes zoster and other serious infection risks during baricitinib treatment, especially in the first 6 months.
Cited by 17
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Cited by 1
- 6 August 2024
- Published by Oxford University Press (OUP) in Modern Rheumatology
Effects of cyclophosphamide administration on ovarian dysfunction in pediatric patients with connective tissue diseases: A systematic scoping review
by Ken-Ei Sada, Takako Miyamae, Kayoko Kaneko, Sakiko Isojima, Kunihiro Ichinose, Masakazu Matsushita, Kenji Oku, Yasunori Iwata, Keishi Fujio, Atsuko Murashima, et al.
Objective: This systematic scoping review assess the effect of cyclophosphamide (CY) administration during childhood on ovarian function in patients with juvenile-onset connective tissue diseases. Methods: A MEDLINE database search was conducted using terms related to CY, juvenile-onset connective tissue diseases, and ovarian function. Studies were included if they met specific criteria. Results: The search, conducted on 28 November 2023, yielded 3328 references. After a two-stage screening process, six observational studies on systemic lupus erythematosus patients were included. All studies had a high risk of confounding bias, as none adjusted for confounding variables. Two studies assessing clinical ovarian dysfunction found no clear difference between CY and non-CY groups. However, statistical differences were observed in hormonal profiles. Decreased ovarian reserve was more frequent in CY-exposed patients. Two studies showed significantly higher follicle-stimulating hormone (FSH) levels in the CY group, while one showed a trend towards higher FSH levels without statistical significance. Conclusion: This review suggested that CY use in childhood may not conclusively have clinically significant effects on ovarian function. Further investigation needed on CY’s effect on hormonal levels, fertility, and pregnancy outcomes.
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- 6 August 2024
- Published by Oxford University Press (OUP) in Modern Rheumatology
Open Access
Effects of cyclophosphamide administration on ovarian dysfunction in pediatric patients with connective tissue diseases: A systematic scoping review
by Ken-Ei Sada, Takako Miyamae, Kayoko Kaneko, Sakiko Isojima, Kunihiro Ichinose, Masakazu Matsushita, Kenji Oku, Yasunori Iwata, Keishi Fujio, Atsuko Murashima, et al.
Objective: This systematic scoping review assess the effect of cyclophosphamide (CY) administration during childhood on ovarian function in patients with juvenile-onset connective tissue diseases. Methods: A MEDLINE database search was conducted using terms related to CY, juvenile-onset connective tissue diseases, and ovarian function. Studies were included if they met specific criteria. Results: The search, conducted on 28 November 2023, yielded 3328 references. After a two-stage screening process, six observational studies on systemic lupus erythematosus patients were included. All studies had a high risk of confounding bias, as none adjusted for confounding variables. Two studies assessing clinical ovarian dysfunction found no clear difference between CY and non-CY groups. However, statistical differences were observed in hormonal profiles. Decreased ovarian reserve was more frequent in CY-exposed patients. Two studies showed significantly higher follicle-stimulating hormone (FSH) levels in the CY group, while one showed a trend towards higher FSH levels without statistical significance. Conclusion: This review suggested that CY use in childhood may not conclusively have clinically significant effects on ovarian function. Further investigation needed on CY’s effect on hormonal levels, fertility, and pregnancy outcomes.
Cited by 1
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Cited by 2
- 15 May 2023
- Published by Japanese Society of Internal Medicine in Internal Medicine
Subcutaneous Panniculitis-like T-cell Lymphoma with a HAVCR2 Mutation Diagnosed after 10 Years of Treatment with Glucocorticoids and Cyclosporine as Lupus Panniculitis
by Yoshiki Yamamoto, Asako Mitsui, Kentaro Noda, Yasuo Suzuki, Akihiko Sawaki, Toshihiko Shinoki, Hiroshi Imai, Kana Miyazaki, Isao Tawara, Ayako Nakajima
Subcutaneous panniculitis-like T cell lymphoma (SPTCL) is a very rare cutaneous T cell lymphoma that has been reported to be associated with autoimmune disorders but is most commonly associated with systemic lupus erythematosus. We herein report a 26-year-old man thought to have lupus panniculitis (LP) treated for 10 years with corticosteroids and cyclosporine. After several relapses with panniculitis, he was finally diagnosed with SPTCL, which was confirmed to have a HAVCR2 mutation for p.Tyr82Cys. We emphasize that rheumatologists should be aware of the possibility of SPTCL, despite its rare appearance, when making a diagnosis of LP or when encountering clinical manifestations that are not consistent with LP.
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- 15 May 2023
- Published by Japanese Society of Internal Medicine in Internal Medicine
Open Access
Subcutaneous Panniculitis-like T-cell Lymphoma with a HAVCR2 Mutation Diagnosed after 10 Years of Treatment with Glucocorticoids and Cyclosporine as Lupus Panniculitis
by Yoshiki Yamamoto, Asako Mitsui, Kentaro Noda, Yasuo Suzuki, Akihiko Sawaki, Toshihiko Shinoki, Hiroshi Imai, Kana Miyazaki, Isao Tawara, Ayako Nakajima
Subcutaneous panniculitis-like T cell lymphoma (SPTCL) is a very rare cutaneous T cell lymphoma that has been reported to be associated with autoimmune disorders but is most commonly associated with systemic lupus erythematosus. We herein report a 26-year-old man thought to have lupus panniculitis (LP) treated for 10 years with corticosteroids and cyclosporine. After several relapses with panniculitis, he was finally diagnosed with SPTCL, which was confirmed to have a HAVCR2 mutation for p.Tyr82Cys. We emphasize that rheumatologists should be aware of the possibility of SPTCL, despite its rare appearance, when making a diagnosis of LP or when encountering clinical manifestations that are not consistent with LP.
Cited by 2
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Cited by 8
- 15 February 2023
- Published by Japanese Society of Internal Medicine in Internal Medicine
A Woman with Rheumatoid Arthritis Who Successfully Delivered a Healthy Child with Continuous Administration of Sarilumab Throughout Pregnancy
by Satoshi Mizutani, Yuki Okunishi, Tatsuya Tamada, Hiroyuki Tanaka, Yuhei Ito, Yoshiki Yamamoto, Asa Kitamura, Hiroaki Tanaka, Tomoaki Ikeda, Ayako Nakajima
We herein report a patient with rheumatoid arthritis (RA) who successfully delivered a healthy child with continuous administration of sarilumab throughout pregnancy. She delivered her first child, a healthy boy, following in vitro fertilization-embryo transfer (IVF-ET) while using etanercept and low-dose prednisolone. Disease activity persisted after delivery, so etanercept was switched to sarilumab. She became pregnant by IVF-ET again. Because RA was still active, sarilumab was continued during pregnancy. She delivered a healthy girl at the 38th week of gestation by Caesarean section. No abnormalities were detected at or within 6 months after birth. Sarilumab was safe and effective in this pregnant woman with RA.
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- 15 February 2023
- Published by Japanese Society of Internal Medicine in Internal Medicine
Open Access
A Woman with Rheumatoid Arthritis Who Successfully Delivered a Healthy Child with Continuous Administration of Sarilumab Throughout Pregnancy
by Satoshi Mizutani, Yuki Okunishi, Tatsuya Tamada, Hiroyuki Tanaka, Yuhei Ito, Yoshiki Yamamoto, Asa Kitamura, Hiroaki Tanaka, Tomoaki Ikeda, Ayako Nakajima
We herein report a patient with rheumatoid arthritis (RA) who successfully delivered a healthy child with continuous administration of sarilumab throughout pregnancy. She delivered her first child, a healthy boy, following in vitro fertilization-embryo transfer (IVF-ET) while using etanercept and low-dose prednisolone. Disease activity persisted after delivery, so etanercept was switched to sarilumab. She became pregnant by IVF-ET again. Because RA was still active, sarilumab was continued during pregnancy. She delivered a healthy girl at the 38th week of gestation by Caesarean section. No abnormalities were detected at or within 6 months after birth. Sarilumab was safe and effective in this pregnant woman with RA.
Cited by 8
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Cited by 8
- 15 August 2022
- Published by The Journal of Rheumatology in The Journal of Rheumatology
Development of Pulmonary Alveolar Proteinosis in a Patient With Adult-Onset Still Disease Treated With Tocilizumab
by Yuhei Ito, Hiroki Nakahara, Ayako Nakajima
We report a patient with systemic adult-onset Still disease (AOSD) who developed anti–granulocyte-macrophage colony-stimulating factor (GM-CSF)–positive pulmonary alveolar proteinosis (PAP) while using tocilizumab (TCZ), diagnosed by milky white bronchoalveolar lavage fluid (BALF; Figure 1). To our knowledge, this is the first case of PAP in AOSD.
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- 15 August 2022
- Published by The Journal of Rheumatology in The Journal of Rheumatology
Development of Pulmonary Alveolar Proteinosis in a Patient With Adult-Onset Still Disease Treated With Tocilizumab
by Yuhei Ito, Hiroki Nakahara, Ayako Nakajima
We report a patient with systemic adult-onset Still disease (AOSD) who developed anti–granulocyte-macrophage colony-stimulating factor (GM-CSF)–positive pulmonary alveolar proteinosis (PAP) while using tocilizumab (TCZ), diagnosed by milky white bronchoalveolar lavage fluid (BALF; Figure 1). To our knowledge, this is the first case of PAP in AOSD.
Cited by 8
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Cited by 4
- 27 November 2021
- Published by Japanese Society of Internal Medicine in Internal Medicine
Pneumatosis Intestinalis Developed in a Patient with Giant Cell Arteritis While in a Clinically Sustained Remission Phase
by Kaya Aonuma, Yoshiki Yamamoto, Tatsuya Tamada, Yuhei Ito, Kentaro Noda, Yasuo Suzuki, Ayako Nakajima
We herein report a patient with giant cell arteritis (GCA) who developed pneumatosis intestinalis (PI) while she was in a clinically sustained remission phase. A 79-year-old woman with GCA involving the thoracic aorta and its first branches to the posterior tibial arteries had been treated with high-dose prednisolone. Nine weeks after initiating treatment and while in clinically sustained remission with a normal CRP level, PI and pneumoperitoneum were incidentally found during scheduled positron emission tomography-computed tomography, which also revealed slight residual inflammation of GCA. This is a very rare case of PI complicated by GCA, and we discuss the possible relationships.
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- 27 November 2021
- Published by Japanese Society of Internal Medicine in Internal Medicine
Open Access
Pneumatosis Intestinalis Developed in a Patient with Giant Cell Arteritis While in a Clinically Sustained Remission Phase
by Kaya Aonuma, Yoshiki Yamamoto, Tatsuya Tamada, Yuhei Ito, Kentaro Noda, Yasuo Suzuki, Ayako Nakajima
We herein report a patient with giant cell arteritis (GCA) who developed pneumatosis intestinalis (PI) while she was in a clinically sustained remission phase. A 79-year-old woman with GCA involving the thoracic aorta and its first branches to the posterior tibial arteries had been treated with high-dose prednisolone. Nine weeks after initiating treatment and while in clinically sustained remission with a normal CRP level, PI and pneumoperitoneum were incidentally found during scheduled positron emission tomography-computed tomography, which also revealed slight residual inflammation of GCA. This is a very rare case of PI complicated by GCA, and we discuss the possible relationships.
Cited by 4
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Cited by 6
- 1 June 2021
- Published by Elsevier in Annals of the Rheumatic Diseases
AB0249 SAFETY OF BARICITINIB IN JAPANESE PATIENTS WITH RHEUMATOID ARTHRITIS (RA): THE 2020 INTERIM REPORT FROM ALL-CASE POST MARKETING SURVEILLANCE IN CLINICAL PRACTICE
by T. Fujii, T. Atsumi, N. Okamoto, N. Takahashi, N. Tamura, A. Nakajima, H. Matsuno, N. Tsujimoto, A. Nishikawa, T. Ishii, et al.
Background: An all-case post marketing surveillance (PMS) of baricitinib (Bari), that started in Sep 2017, collects safety and effectiveness for the first 24 wks of treatment and continues to collect serious adverse events (SAEs) for 3 yrs. Objectives: To evaluate Bari safety in RA patients (pt) in clinical practice. Methods: We report pt baseline demographics and adverse events (AEs) up to 24 wks for pts whose case report files for 24-wk data were completed as of Jun 2020. Results: Data from 3445 pts were analyzed (females=80%, mean age=64yr, mean RA duration 12yr). Bari dose regimen was as follows: 4mg, 60%, 2mg, 27%, 4mg→2mg, 5%, 2mg→4mg, 5%, and others, 2%. Concomitant use of MTX and glucocorticoid was 65% and 48%, respectively. 74% continued treatment for 24 wks. AE and SAE were recognized in 887 (26%) and 122 pts (4%), respectively. 6 pts died of pneumonia, aspiration pneumonia, bacterial pneumonia, cerebral infarction/ILD/aspiration pneumonia, adenocarcinoma, and colorectal cancer. Major AEs were as follows: herpes zoster=3%, liver dysfunction=3%, serious infection=1%, anemia=1%, hyperlipidemia=1%, malignancy=0.3%, interstitial pneumonia=0.2%, MACE=0.1%, and VTE=0.1%. Conclusion: Data do not show new safety concerns and encourage guideline-compliant use of Bari. Disclosure of Interests: Takao Fujii Speakers bureau: Chugai Pharmaceutical Co. Ltd.; Eisai Co. Ltd; Eli Lilly Japan K.K.; Janssen Pharmaceutical K.K.; Ono Pharmaceutical Co. Ltd., Consultant of: Asahikasei Pharma Corp, Grant/research support from: Asahikasei Pharma Corp; AbbVie Japan GK; Chugai Pharmaceutical Co. Ltd., Eisai Co. Ltd; Eli Lilly Japan K.K.; Mitsubishi-Tanabe Pharma Co.; Ono Pharmaceutical Co., Ltd., Tatsuya Atsumi Speakers bureau: AbbVie Japan GK; Astellas Pharma Inc.; Bristol-Myers Squibb Co. Ltd; Chugai Pharmaceutical Co. Ltd.; Daiichi Sankyo Co. Ltd.; Eisai Co. Ltd.; Eli Lilly Japan K.K.; Mitsubishi Tanabe Pharma Co.; Pfizer Japan Inc.; Takeda Pharmaceutical Co. Ltd., UCB Japan Co. Ltd., Consultant of: AbbVie Japan GK; AstraZeneca plc.; Boehringer Ingelheim Co. Ltd.; Medical & Biological Laboratories Co. Ltd.; Novartis Pharma K.K.; Ono Pharmaceutical Co. Ltd.; Pfizer Japan Inc., Grant/research support from: Astellas Pharma Inc., Alexion Inc.; Chugai Pharmaceutical Co. Ltd., Daiichi Sankyo Co. Ltd., Mitsubishi Tanabe Pharma Co., Otsuka Pharmaceutical Co., Ltd. Pfizer Japan Inc.; Takeda Pharmaceutical Co. Ltd., Nami Okamoto Speakers bureau: AbbVie Japan GK; Asahikasei Pharma Co.; AYUMI Pharmaceutical Co. Eisai Co. Ltd; Bristol-Myers Squibb Co. Ltd.; Eli Lilly Japan K.K.; Mitsubishi-Tanabe Pharma Co.; Pfizer Japan Inc. Sanofi K.K.; Chugai Pharmaceutical Co. Ltd.; Novartis Pharma Co.; Teijin Pharma Ltd.; Torii Pharmaceutical Co., Ltd., Nobunori Takahashi Speakers bureau: AbbVie Japan GK; Eisai Co. Ltd.; Mitsubishi Tanabe Pharma Co.; Pfizer Japan Inc.; Chugai Pharmaceutical Co., Ltd.; Eli Lilly Japan K.K.; Janssen Pharmaceutical K.K.; UCB Japan Co. Ltd.; Astellas Pharma Inc.; Bristol Myers Squibb Co. Ltd., Grant/research support from: Bristol Myers Squibb Co. Ltd., Naoto Tamura Speakers bureau: AbbVie Japan GK; Bristol Myers Squibb Co. Ltd.; Chugai Pharmaceutical Co. Ltd.; Eisai Co. Ltd.; Eli Lilly Japan K.K.; Glaxo Smith Kline K.K.; Janssen Pharmaceutical K.K.; Mitsubishi-Tanabe Pharma Co.; Novartis Pharma Co., Atsuo Nakajima: None declared, Ayako Nakajima Speakers bureau: AbbVie Japan GK; Actelion Pharmaceuticals Japan Ltd., Asahi Kasei Pharma Co., Astellas Pharma Inc., Ayumi Pharmaceutical Co., Bristol Myers Squibb Co., Ltd.,Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Eli Lilly Japan K.K., Glaxo Smith Kline K.K., Hisamitsu Pharmaceutical Co. Inc., Kyorin Pharmaceutical Co. Ltd., Mitsubishi Tanabe Pharma Co., Otsuka Pharmaceutical Co. Ltd., Pfizer Japan Inc., Teijin Pharma Ltd., Grant/research support from: Chugai Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Co., Pfizer Japan Inc., Hiroaki Matsuno Speakers bureau: Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Eli Lilly Japan K.K., Consultant of: Mochida Pharmaceutical Co., Ltd., Grant/research support from: Astellas Pharma Inc., Eli Lilly Japan K.K.; Janssen Pharmaceutical K.K, Naoto Tsujimoto Shareholder of: Eli Lilly, Employee of: Eli Lilly Japan K.K., Atsushi Nishikawa Shareholder of: Eli Lilly, Employee of: Eli Lilly Japan K.K., Taeko Ishii Shareholder of: Eli Lilly, Employee of: Eli Lilly Japan K.K., Tsutomu Takeuchi Speakers bureau: AbbVie Japan GK, Ayumi Pharmaceutical Co., Bristol Myers Squibb Co., Ltd., Chugai Pharmaceutical Co, Ltd. Daiichi Sankyo Co., Ltd. Eisai Co., Ltd. Eli Lilly Japan K.K.; Gilead Sciences, Inc. Janssen Pharmaceutical K.K.; Mitsubishi-Tanabe Pharma Co.; Novartis Pharma Co.; Pfizer Japan Inc.; Sanofi K.K.; UCB Japan Co., Ltd., Consultant of: AbbVie Japan GK, Astellas Pharma, Inc.; Chugai Pharmaceutical Co, Ltd.; Eli Lilly Japan K.K.; Eisai Co., Ltd.; Gilead Sciences, Inc.; Janssen Pharmaceutical K.K.; Mitsubishi-Tanabe Pharma Corp., Pfizer Japan Inc., Grant/research support from: AbbVie Japan GK, Asahikasei Pharma Corp., Chugai Pharmaceutical Co, Ltd., DNA Chip Research Inc.; Eisai Co., Ltd., Eli Lilly Japan K.K.; Mitsubishi-Tanabe Pharma Corp., UCB Japan Co., Ltd., Masataka Kuwana Speakers bureau: AbbVie Japan GK, Astellas Pharma Inc., Asahi Kasei Pharma Co., Boehringer-Ingelheim, Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Janssen Pharmaceutical K.K., Medical &Biological Laboratories Co., Ltd.; Mitsubishi Tanabe Pharma Co.; Mochida Pharmaceutical Co., Ltd., Nippon Shinyaku Co., Ltd.; Ono Pharmaceutical Co., Ltd.; Pfizer Japan Inc., Consultant of: Boehringer-Ingelheim, Chugai Pharmaceutical Co., Ltd., Corbus Pharmaceuticals Holdings, Inc.; Medical &Biological Laboratories Co., Ltd.; Mochida Pharmaceutical Co., Ltd., Grant/research support from: Boehringer-Ingelheim, Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Medical &Biological Laboratories Co., Ltd; Mitsubishi Tanabe Pharma Co., Ono Pharmaceutical Co., Ltd., Michiaki Takagi Speakers bureau: Yes, but sponsored lectures without COI in the academic meetings, only.
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- 1 June 2021
- Published by Elsevier in Annals of the Rheumatic Diseases
Open Access
AB0249 SAFETY OF BARICITINIB IN JAPANESE PATIENTS WITH RHEUMATOID ARTHRITIS (RA): THE 2020 INTERIM REPORT FROM ALL-CASE POST MARKETING SURVEILLANCE IN CLINICAL PRACTICE
by T. Fujii, T. Atsumi, N. Okamoto, N. Takahashi, N. Tamura, A. Nakajima, H. Matsuno, N. Tsujimoto, A. Nishikawa, T. Ishii, et al.
Background: An all-case post marketing surveillance (PMS) of baricitinib (Bari), that started in Sep 2017, collects safety and effectiveness for the first 24 wks of treatment and continues to collect serious adverse events (SAEs) for 3 yrs. Objectives: To evaluate Bari safety in RA patients (pt) in clinical practice. Methods: We report pt baseline demographics and adverse events (AEs) up to 24 wks for pts whose case report files for 24-wk data were completed as of Jun 2020. Results: Data from 3445 pts were analyzed (females=80%, mean age=64yr, mean RA duration 12yr). Bari dose regimen was as follows: 4mg, 60%, 2mg, 27%, 4mg→2mg, 5%, 2mg→4mg, 5%, and others, 2%. Concomitant use of MTX and glucocorticoid was 65% and 48%, respectively. 74% continued treatment for 24 wks. AE and SAE were recognized in 887 (26%) and 122 pts (4%), respectively. 6 pts died of pneumonia, aspiration pneumonia, bacterial pneumonia, cerebral infarction/ILD/aspiration pneumonia, adenocarcinoma, and colorectal cancer. Major AEs were as follows: herpes zoster=3%, liver dysfunction=3%, serious infection=1%, anemia=1%, hyperlipidemia=1%, malignancy=0.3%, interstitial pneumonia=0.2%, MACE=0.1%, and VTE=0.1%. Conclusion: Data do not show new safety concerns and encourage guideline-compliant use of Bari. Disclosure of Interests: Takao Fujii Speakers bureau: Chugai Pharmaceutical Co. Ltd.; Eisai Co. Ltd; Eli Lilly Japan K.K.; Janssen Pharmaceutical K.K.; Ono Pharmaceutical Co. Ltd., Consultant of: Asahikasei Pharma Corp, Grant/research support from: Asahikasei Pharma Corp; AbbVie Japan GK; Chugai Pharmaceutical Co. Ltd., Eisai Co. Ltd; Eli Lilly Japan K.K.; Mitsubishi-Tanabe Pharma Co.; Ono Pharmaceutical Co., Ltd., Tatsuya Atsumi Speakers bureau: AbbVie Japan GK; Astellas Pharma Inc.; Bristol-Myers Squibb Co. Ltd; Chugai Pharmaceutical Co. Ltd.; Daiichi Sankyo Co. Ltd.; Eisai Co. Ltd.; Eli Lilly Japan K.K.; Mitsubishi Tanabe Pharma Co.; Pfizer Japan Inc.; Takeda Pharmaceutical Co. Ltd., UCB Japan Co. Ltd., Consultant of: AbbVie Japan GK; AstraZeneca plc.; Boehringer Ingelheim Co. Ltd.; Medical & Biological Laboratories Co. Ltd.; Novartis Pharma K.K.; Ono Pharmaceutical Co. Ltd.; Pfizer Japan Inc., Grant/research support from: Astellas Pharma Inc., Alexion Inc.; Chugai Pharmaceutical Co. Ltd., Daiichi Sankyo Co. Ltd., Mitsubishi Tanabe Pharma Co., Otsuka Pharmaceutical Co., Ltd. Pfizer Japan Inc.; Takeda Pharmaceutical Co. Ltd., Nami Okamoto Speakers bureau: AbbVie Japan GK; Asahikasei Pharma Co.; AYUMI Pharmaceutical Co. Eisai Co. Ltd; Bristol-Myers Squibb Co. Ltd.; Eli Lilly Japan K.K.; Mitsubishi-Tanabe Pharma Co.; Pfizer Japan Inc. Sanofi K.K.; Chugai Pharmaceutical Co. Ltd.; Novartis Pharma Co.; Teijin Pharma Ltd.; Torii Pharmaceutical Co., Ltd., Nobunori Takahashi Speakers bureau: AbbVie Japan GK; Eisai Co. Ltd.; Mitsubishi Tanabe Pharma Co.; Pfizer Japan Inc.; Chugai Pharmaceutical Co., Ltd.; Eli Lilly Japan K.K.; Janssen Pharmaceutical K.K.; UCB Japan Co. Ltd.; Astellas Pharma Inc.; Bristol Myers Squibb Co. Ltd., Grant/research support from: Bristol Myers Squibb Co. Ltd., Naoto Tamura Speakers bureau: AbbVie Japan GK; Bristol Myers Squibb Co. Ltd.; Chugai Pharmaceutical Co. Ltd.; Eisai Co. Ltd.; Eli Lilly Japan K.K.; Glaxo Smith Kline K.K.; Janssen Pharmaceutical K.K.; Mitsubishi-Tanabe Pharma Co.; Novartis Pharma Co., Atsuo Nakajima: None declared, Ayako Nakajima Speakers bureau: AbbVie Japan GK; Actelion Pharmaceuticals Japan Ltd., Asahi Kasei Pharma Co., Astellas Pharma Inc., Ayumi Pharmaceutical Co., Bristol Myers Squibb Co., Ltd.,Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Eli Lilly Japan K.K., Glaxo Smith Kline K.K., Hisamitsu Pharmaceutical Co. Inc., Kyorin Pharmaceutical Co. Ltd., Mitsubishi Tanabe Pharma Co., Otsuka Pharmaceutical Co. Ltd., Pfizer Japan Inc., Teijin Pharma Ltd., Grant/research support from: Chugai Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Co., Pfizer Japan Inc., Hiroaki Matsuno Speakers bureau: Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Eli Lilly Japan K.K., Consultant of: Mochida Pharmaceutical Co., Ltd., Grant/research support from: Astellas Pharma Inc., Eli Lilly Japan K.K.; Janssen Pharmaceutical K.K, Naoto Tsujimoto Shareholder of: Eli Lilly, Employee of: Eli Lilly Japan K.K., Atsushi Nishikawa Shareholder of: Eli Lilly, Employee of: Eli Lilly Japan K.K., Taeko Ishii Shareholder of: Eli Lilly, Employee of: Eli Lilly Japan K.K., Tsutomu Takeuchi Speakers bureau: AbbVie Japan GK, Ayumi Pharmaceutical Co., Bristol Myers Squibb Co., Ltd., Chugai Pharmaceutical Co, Ltd. Daiichi Sankyo Co., Ltd. Eisai Co., Ltd. Eli Lilly Japan K.K.; Gilead Sciences, Inc. Janssen Pharmaceutical K.K.; Mitsubishi-Tanabe Pharma Co.; Novartis Pharma Co.; Pfizer Japan Inc.; Sanofi K.K.; UCB Japan Co., Ltd., Consultant of: AbbVie Japan GK, Astellas Pharma, Inc.; Chugai Pharmaceutical Co, Ltd.; Eli Lilly Japan K.K.; Eisai Co., Ltd.; Gilead Sciences, Inc.; Janssen Pharmaceutical K.K.; Mitsubishi-Tanabe Pharma Corp., Pfizer Japan Inc., Grant/research support from: AbbVie Japan GK, Asahikasei Pharma Corp., Chugai Pharmaceutical Co, Ltd., DNA Chip Research Inc.; Eisai Co., Ltd., Eli Lilly Japan K.K.; Mitsubishi-Tanabe Pharma Corp., UCB Japan Co., Ltd., Masataka Kuwana Speakers bureau: AbbVie Japan GK, Astellas Pharma Inc., Asahi Kasei Pharma Co., Boehringer-Ingelheim, Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Janssen Pharmaceutical K.K., Medical &Biological Laboratories Co., Ltd.; Mitsubishi Tanabe Pharma Co.; Mochida Pharmaceutical Co., Ltd., Nippon Shinyaku Co., Ltd.; Ono Pharmaceutical Co., Ltd.; Pfizer Japan Inc., Consultant of: Boehringer-Ingelheim, Chugai Pharmaceutical Co., Ltd., Corbus Pharmaceuticals Holdings, Inc.; Medical &Biological Laboratories Co., Ltd.; Mochida Pharmaceutical Co., Ltd., Grant/research support from: Boehringer-Ingelheim, Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Medical &Biological Laboratories Co., Ltd; Mitsubishi Tanabe Pharma Co., Ono Pharmaceutical Co., Ltd., Michiaki Takagi Speakers bureau: Yes, but sponsored lectures without COI in the academic meetings, only.
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