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Article ; Online: Esketamine Nasal Spray versus Quetiapine for Resistant Depression.

Lan, Chiao-Hsin / Wei, James C-C

2024 Volume 390, Issue 1, Page(s) 93–94

MeSH term(s)	Humans ; Quetiapine Fumarate/therapeutic use ; Nasal Sprays ; Depression/drug therapy ; Antidepressive Agents/therapeutic use
Chemical Substances	Quetiapine Fumarate (2S3PL1B6UJ) ; Nasal Sprays ; Esketamine (50LFG02TXD) ; Antidepressive Agents
Language	English
Publishing date	2024-01-01
Publishing country	United States
Document type	Letter ; Comment
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMc2313230
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Article ; Online: Nirmatrelvir for Nonhospitalized Adults with Covid-19.

Chen, Brian S / Hung, Cheng-Hsien / Wei, James C-C

The New England journal of medicine

2022 Volume 387, Issue 5, Page(s) 474

MeSH term(s)	Adult ; COVID-19 ; Hospitalization ; Humans ; SARS-CoV-2
Language	English
Publishing date	2022-07-20
Publishing country	United States
Document type	Letter ; Comment
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMc2206277
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Article ; Online: Association between long-term opioid use and cancer risk in patients with chronic pain. Comment on Br J Anaesth 2022; 129: 84-91.

Chu, Wei-Min / Huang, Paul S-B / Wei, James C-C

British journal of anaesthesia

2022 Volume 129, Issue 4, Page(s) e104–e105

MeSH term(s)	Analgesics, Opioid/adverse effects ; Chronic Pain/drug therapy ; Humans ; Neoplasms/drug therapy ; Opioid-Related Disorders/complications ; Opioid-Related Disorders/drug therapy ; Risk
Chemical Substances	Analgesics, Opioid
Language	English
Publishing date	2022-08-12
Publishing country	England
Document type	Letter ; Comment
ZDB-ID	80074-0
ISSN	1471-6771 ; 0007-0912
ISSN (online)	1471-6771
ISSN	0007-0912
DOI	10.1016/j.bja.2022.07.007
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Article ; Online: Interleukin-17 inhibitor, is it safer than tumor necrosis factor inhibitor?

Huang, Jinxian / Zhang, Lijun / Wei, James C-C

International journal of rheumatic diseases

2021 Volume 24, Issue 7, Page(s) 865–868

MeSH term(s)	Arthritis/therapy ; Humans ; Interleukin-17/therapeutic use ; Osteoarthritis/therapy ; Tumor Necrosis Factor Inhibitors/therapeutic use
Chemical Substances	IL17A protein, human ; Interleukin-17 ; Tumor Necrosis Factor Inhibitors
Language	English
Publishing date	2021-11-30
Publishing country	England
Document type	Editorial
ZDB-ID	2426924-4
ISSN	1756-185X ; 1756-1841
ISSN (online)	1756-185X
ISSN	1756-1841
DOI	10.1111/1756-185X.14076
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Article ; Online: Suggested Considerations for the Treatment of Rheumatic Diseases in Adult Patients With COVID-19: Comment on the Article by Mikuls et al.

Hsu, Jeffrey / Liu, Chin-Hsiu / Wei, James C

Arthritis & rheumatology (Hoboken, N.J.)

2021 Volume 73, Issue 12, Page(s) 2355

MeSH term(s)	Adult ; COVID-19 ; Humans ; Rheumatic Diseases/drug therapy ; SARS-CoV-2
Language	English
Publishing date	2021-10-28
Publishing country	United States
Document type	Letter ; Comment
ZDB-ID	2756371-6
ISSN	2326-5205 ; 2326-5191
ISSN (online)	2326-5205
ISSN	2326-5191
DOI	10.1002/art.41889
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Article: Neoplasm Risk in Rheumatic Diseases Has No Correlation With Conventional Synthetic Disease-Modifying Anti-rheumatic Drugs Usage-A Population-Based Nested Case-Control Study.

Cai, Shaozhe / Perng, Wuu-Tsun / Huang, Jing Y / Chiou, Jeng-Yuan / Dong, Lingli / Wei, James C

Frontiers in medicine

2020 Volume 7, Page(s) 473

Abstract: Objectives: ...

Abstract	Objectives:
Language	English
Publishing date	2020-08-26
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2775999-4
ISSN	2296-858X
ISSN	2296-858X
DOI	10.3389/fmed.2020.00473
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Article ; Online: Liver-related long-term outcomes of thiazolidinedione use in persons with type 2 diabetes.

Yen, Fu-Shun / Yang, Yu-Cih / Hwu, Chii-Min / Wei, James C-C / Huang, Yi-Hsiang / Hou, Ming-Chih / Hsu, Chih-Cheng

Liver international : official journal of the International Association for the Study of the Liver

2020 Volume 40, Issue 5, Page(s) 1089–1097

Abstract: Background & aims: Studies have described prominent histologic improvement in patients with nonalcoholic steatohepatitis (NASH) using thiazolidinedione (TZD); however, these were all short term with moderate sample size, no liver-related long-term ... ...

Abstract	Background & aims: Studies have described prominent histologic improvement in patients with nonalcoholic steatohepatitis (NASH) using thiazolidinedione (TZD); however, these were all short term with moderate sample size, no liver-related long-term outcomes could be noted. Methods: This retrospective cohort study enrolled patients with newly diagnosed type 2 diabetes mellitus (T2DM) from Taiwan's National Health Insurance Research Database between 1 January 2000 and 31 December 2013. We matched TZD users and nonusers at a 1:1 ratio through propensity score matching. This study included 5095 paired TZD users and nonusers. Cox proportional hazard models were used to compare the risks of cirrhosis, hepatic decompensation, hepatic failure and all-cause mortality between TZD users and nonusers. The Kaplan-Meier method was used to compare the cumulative incidence of these main outcomes. Results: The incidence rates of cirrhosis, hepatic decompensation, hepatic failure and all-cause mortality during follow-up were 0.77 vs 1.95, 1.43 vs 1.75, 0.36 vs 0.70, and 4.89 vs 3.78 per 1000 person-years between TZD users and nonusers. The adjusted hazard ratios of cirrhosis, hepatic decompensation, hepatic failure and all-cause mortality were 0.39 (95% confidence interval [CI]: 0.21-0.72), 0.86 (95% CI: 0.52-1.44), 0.46 (95% CI: 0.18-1.17) and 1.18 (95% CI: 0.87-1.61) respectively. Conclusions: Our study demonstrated that TZD use could significantly lower the risk of cirrhosis. In clinical settings, TZD use might be able to improve liver-related long-term outcomes.
MeSH term(s)	Diabetes Mellitus, Type 2/drug therapy ; Diabetes Mellitus, Type 2/epidemiology ; Humans ; Hypoglycemic Agents/therapeutic use ; Liver ; Retrospective Studies ; Thiazolidinediones/therapeutic use
Chemical Substances	Hypoglycemic Agents ; Thiazolidinediones
Language	English
Publishing date	2020-02-10
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2102783-3
ISSN	1478-3231 ; 1478-3223
ISSN (online)	1478-3231
ISSN	1478-3223
DOI	10.1111/liv.14385
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Article ; Online: Efficacy and safety of secukinumab in Asian patients with active ankylosing spondylitis: 52-week pooled results from two phase 3 studies.

Wei, James C-C / Baeten, Dominique / Sieper, Joachim / Deodhar, Atul / Bhosekar, Vaishali / Martin, Ruvie / Porter, Brian

International journal of rheumatic diseases

2017 Volume 20, Issue 5, Page(s) 589–596

Abstract: Aim: To evaluate efficacy and safety of secukinumab in Asian patients with active ankylosing spondylitis (AS) via a pooled subgroup analysis from two phase 3 studies, MEASURE 1 (NCT01358175) and MEASURE 2 (NCT01649375).: Methods: In MEASURE 1, ... ...

Abstract	Aim: To evaluate efficacy and safety of secukinumab in Asian patients with active ankylosing spondylitis (AS) via a pooled subgroup analysis from two phase 3 studies, MEASURE 1 (NCT01358175) and MEASURE 2 (NCT01649375). Methods: In MEASURE 1, patients were randomized to intravenous secukinumab 10 mg/kg or placebo at baseline, Weeks 2 and 4, followed by subcutaneous (s.c.) secukinumab 150 mg, 75 mg or placebo every 4 weeks (q4w) at Week 8. In MEASURE 2, patients were randomized to s.c. secukinumab 150 mg, 75 mg or placebo at baseline, Weeks 1, 2 and 3, and q4w starting at Week 4. Efficacy outcomes were SpondyloArthritis International Society (ASAS) 20/40, high-sensitivity C-reactive protein (hsCRP), ASAS5/6, Bath Ankylosing Spondylitis Disease Activity Index, Short Form-36 physical component summary, AS quality of life (QoL), ASAS partial remission, and Ankylosing Spondylitis Disease Activity Score - CRP at Weeks 16 and 52. Due to lack of efficacy, the secukinumab 75 mg dose in MEASURE 2 was excluded from this pooled Asian subgroup analysis. Safety analysis included patients who received ≥ 1 dose of study treatment. Results: Of 517 patients enrolled into the MEASURE studies, 69 (13.3%) were Asians: 46 in pooled secukinumab and 23 in placebo. At Week 16, ASAS20/40 responses in Asian patients were 69.6%/43.5% with pooled secukinumab versus 26.1%/17.4% with placebo, which were comparable with rates reported in the overall study population. Secukinumab improved predefined efficacy endpoints at Week 16, with responses sustained through Week 52. Secukinumab was well tolerated in Asian patients, with a safety profile consistent with that reported in the overall study population. Conclusion: Secukinumab improved signs and symptoms, physical function, and disease-specific QoL in Asian patients with active AS.
Language	English
Publishing date	2017-05
Publishing country	England
Document type	Journal Article
ZDB-ID	2426924-4
ISSN	1756-185X ; 1756-1841
ISSN (online)	1756-185X
ISSN	1756-1841
DOI	10.1111/1756-185X.13094
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Article: Long-term effects of interleukin-17A inhibition with secukinumab in active ankylosing spondylitis: 3-year efficacy and safety results from an extension of the Phase 3 MEASURE 1 trial.

Baraliakos, Xenofon / Kivitz, Alan J / Deodhar, Atul A / Braun, Jürgen / Wei, James C / Delicha, Eumorphia Maria / Talloczy, Zsolt / Porter, Brian

Clinical and experimental rheumatology

2017

Abstract: Objectives: Secukinumab, a fully human anti-IL-17A monoclonal antibody, provided rapid and sustained improvements in signs and symptoms of ankylosing spondylitis (AS) over 2 years in the Phase 3 MEASURE 1 trial. Here, we report efficacy and safety after ...

Abstract	Objectives: Secukinumab, a fully human anti-IL-17A monoclonal antibody, provided rapid and sustained improvements in signs and symptoms of ankylosing spondylitis (AS) over 2 years in the Phase 3 MEASURE 1 trial. Here, we report efficacy and safety after 3 years of treatment. Methods: AS subjects completing 2 years of treatment every 4 weeks with subcutaneous secukinumab 150 or 75 mg (following intravenous loading or initial placebo treatment to 16/24 weeks) entered a separate 3-year extension study (NCT01863732). Assessments included ASAS20/40, ASAS5/6, BASDAI, BASDAI 50, BASFI, BASMI, SF-36 physical component summary, ASAS partial remission and ASDAS-CRP. Results were also analysed by prior anti-TNF treatment status. Results: Among 290 subjects completing the core trial, 274 entered the extension study, with 260 subjects (94.9%) completing 156 weeks of treatment. ASAS20/40 response (observed) was 80.2%/61.6% in the IV→150 mg group and 75.5%/50.0% in the IV→75 mg group after 156 weeks. Sustained improvements were also seen in BASDAI, BASFI, BASMI and across all other endpoints regardless of previous exposure to anti-TNF agents. Mean secukinumab exposure was 964.3 days (137.8 weeks). Discontinuation rates were low, and secukinumab had a favourable safety profile, consistent with previous reports. Exposure-adjusted incidence rates for serious infections, Candida infections, Crohn's disease, ulcerative colitis, malignant/unspecified tumours, and adjudicated major adverse cardiac events were 1.1, 0.4, 0.5, 0.1, 0.5 and 0.7 per 100 subject-years, respectively. Conclusions: Secukinumab provided sustained efficacy in signs, symptoms and physical function in subjects with AS over 3 years. No new safety signals were observed.
Language	English
Publishing date	2017-05-15
Publishing country	Italy
Document type	Journal Article
ZDB-ID	605886-3
ISSN	1593-098X ; 0392-856X
ISSN (online)	1593-098X
ISSN	0392-856X
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Article ; Online: Tofacitinib as monotherapy following methotrexate withdrawal in patients with psoriatic arthritis previously treated with open-label tofacitinib plus methotrexate: a randomised, placebo-controlled substudy of OPAL Balance.

Nash, Peter / Mease, Philip J / Fleishaker, Dona / Wu, Joseph / Coates, Laura C / Behrens, Frank / Gladman, Dafna D / Kivitz, Alan J / Wei, James C / Shirinsky, Ivan / Menon, Sujatha / Romero, Ana B / Fallon, Lara / Hsu, Ming-Ann / Wang, Cunshan / Kanik, Keith S

The Lancet. Rheumatology

2020 Volume 3, Issue 1, Page(s) e28–e39

Abstract: Background: Tofacitinib is an oral Janus kinase inhibitor for the treatment of psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis. This study evaluated the efficacy and safety of tofacitinib 5 mg twice daily monotherapy after methotrexate ...

Abstract	Background: Tofacitinib is an oral Janus kinase inhibitor for the treatment of psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis. This study evaluated the efficacy and safety of tofacitinib 5 mg twice daily monotherapy after methotrexate withdrawal. Methods: OPAL Balance was an open-label, long-term extension study of tofacitinib in patients with psoriatic arthritis who participated in the OPAL Broaden and OPAL Beyond phase 3 studies. This 12-month, randomised, double-blind, placebo-controlled, methotrexate withdrawal substudy (50 centres, 14 countries) included patients from OPAL Balance who completed tofacitinib treatment for 24 months or more (≥3 months' stable tofacitinib 5 mg twice daily) and were receiving methotrexate (7·5-20 mg/week). Patients were blindly randomised (1:1) using interactive response technology and received open-label tofacitinib 5 mg twice daily with either placebo (tofacitinib 5 mg twice daily plus placebo group) or continued methotrexate (tofacitinib 5 mg twice daily plus methotrexate group). Patients were masked to placebo or methotrexate, with identical capsules used. Coprimary endpoints were changes from substudy baseline in psoriatic arthritis disease activity score (PASDAS) and health assessment questionnaire-disability index (HAQ-DI) at month 6 in all randomised patients with one or more substudy drug dose. Safety was assessed throughout. No specific statistical hypothesis (either superiority or non-inferiority) was tested. The study (OPAL Balance) is registered with ClinicalTrials.gov (NCT01976364) and is complete. Findings: Between Oct 30, 2017, and May 20, 2019, 180 patients from OPAL Balance who were eligible for the substudy were randomly assigned to treatment (90 patients received tofacitinib 5 mg twice daily plus placebo and 89 patients assigned to tofacitinib plus methotrexate; one patient was not treated because of randomisation error). At month 6, least squares mean (LSM) changes in PASDAS were 0·23 (SE 0·08) for tofacitinib 5 mg twice daily plus placebo and 0·14 (0·08) for tofacitinib 5 mg twice daily plus methotrexate (treatment difference LSM 0·09 [95% CI -0·13 to 0·31]), and changes in HAQ-DI were 0·04 (0·03) and 0·02 (0·03), respectively (treatment difference 0·03 [-0·05 to 0·10]). Rates of adverse events, discontinuations because of adverse events, adverse events of special interest, and laboratory changes were generally similar between treatment groups, although liver enzyme elevations were more common with tofacitinib 5 mg twice daily plus methotrexate than tofacitinib 5 mg twice daily plus placebo. Flares of worsening symptoms was reported in one (1%) of 90 patients in the tofacitinib 5 mg twice daily plus placebo group (recorded as psoriatic arthropathy). Interpretation: Some patients with psoriatic arthritis who are stable on tofacitinib 5 mg twice daily with background methotrexate might be able to discontinue methotrexate without clinically meaningful changes in disease activity and safety. Funding: Pfizer Inc.
Language	English
Publishing date	2020-11-16
Publishing country	England
Document type	Journal Article
ISSN	2665-9913
ISSN (online)	2665-9913
DOI	10.1016/S2665-9913(20)30339-8
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