Clinical Practice Recommendations for the Prevention and Management of Intravesical Therapy–Associated Adverse Events

Background:In 2017, 2 Etanercept biosimilars became approved. Comparative studies performed in adult patients with rheumatoid arthritis, ankylosing spondylitis or psoriasis by extrapolation led to approval for juvenile idiopathic arthritis (JIA).Objectives:So far there is limited experience with Etanercept biosimilars in JIA: The large national data base of the BIKER-registry was used to describe experience with Etanercept biosimilars in clinical practice.Methods:In this retrospective analysis patients exposed to ETA were identified in the German BIKER-registry and grouped into cohorts according to initiation of treatment after 2017, use of the originator and of biosimilars. The course of JADAS10, Physician global assessment VAS 0–100-mm, Parent/patient global assessment VAS 0–100-cm, Active joint count 0-71, truncated at 10, ESR and CHAQ-DI was analyzed. Descriptive statistics was used for demographic, clinical data, drug exposure, adverse events (AEs) and events of special interest (ESI).Results:Until 31.10.2020, 2917 JIA patients were reported to have received Etanercept. Since January 1 2017, in 39 centres treatment with Etanercept was started in 439 patients (377 (85.9%) started with the originator and 62 (14.1%) started a Biosimilar). Biosimilars were prescribed n 17 centres (44%). In 12 centres (31%), Etanercept biosimilars were used first line in 62 patients. In 17 centres (44%), 63 patients switched for the originator to a biosimilar. 3 patients reswitched from the biosimilar to the originator. 4 patient switched from a biosimilar to the originator). 22 centres (56%) had not prescribed a biosimilars so far.In not a single centre, initiation of a biosimilar was more frequent than of the originator.The patients’ characteristics and disease activity parameters were widely comparanble. Patients receiving biosimilar first line were slightly older at disease onset and had a longer disease duration. Patients receiving biosimilar first line had more often rheumatoid factor (RF) negative polyarthritis while extended oligoarthritis was more frequent in the originator cohort. In the switching cohort, more patients had extended oligoarthritis and fewer had RF negative polyarthritis and ERA JIA.No difference in disease activity parameters was noted, neither at baseline, during the course of treatment nor at last observation upon treatment. A decrease of the JADAS10 indicates improvement in both groups (Figure 1). At the time of switching, 68% had JADAS minimal disease activity (MDA) and 43% were in JASDAS remission. At month 6 and 12 these numbers increased to 74%/65% and 62%/50%.In total, 66 adverse events (AE) were reported in 45 patients upon biosimilar treatment.33 patients had 1, 5 patients 2, 5 patients had 3 and 2 reported 4 events. Adverse event of special interest were hypersensitivity n=1, injection site reaction n=1, new onset of psoriasis n=1, celiac disease n=1, Crohn‘s diesease n=1, elevated transaminases n=2, depression n=1 and disease deterioration (arthritis flare) in n=21. In 20 patients, the etanercept biosimilar was discontinued.Conclusion:This analysis is the first attempt to present a large data sample on JIA patients exposed to Etanercept biosimilars. Biosimilar were used in a minority of patients and by a minority of centers although no difference in efficacy or safety was noted from our analysis. Until today, the use of the originator is by far exceeding the use of biosimilars. The prescription of a biosimilar either first line or by switching from the originator is limited to a part of centres. Differences in efficacy between first line biosimilar users and originator users could not be observed. Also, after switching, no loss of efficacy was observed.Disclosure of Interests:Gerd Horneff Speakers bureau: Pfizer, Daniel Windschall: None declared, Toni Hospach: None declared, Sonja Mrusek: None declared, Michael Rühlmann: None declared, Ariane Klein: None declared

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Clinical practice recommendations for recurrence of focal and segmental glomerulosclerosis/steroid‐resistant nephrotic syndrome

Pediatric Transplantation ◽

10.1111/petr.13955 ◽

2020 ◽

Author(s):

Lutz T. Weber ◽

Burkhard Tönshoff ◽

Ryszard Grenda ◽

Antonia Bouts ◽

Rezan Topaloglu ◽

...

Keyword(s):

Nephrotic Syndrome ◽

Clinical Practice ◽

Focal And Segmental Glomerulosclerosis ◽

Steroid Resistant ◽

Steroid Resistant Nephrotic Syndrome ◽

Practice Recommendations ◽

Segmental Glomerulosclerosis

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AB0249 SAFETY OF BARICITINIB IN JAPANESE PATIENTS WITH RHEUMATOID ARTHRITIS (RA): THE 2020 INTERIM REPORT FROM ALL-CASE POST MARKETING SURVEILLANCE IN CLINICAL PRACTICE

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.433 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 1150.1-1150

Author(s):

T. Fujii ◽

T. Atsumi ◽

N. Okamoto ◽

N. Takahashi ◽

N. Tamura ◽

...

Keyword(s):

Clinical Practice ◽

Adverse Events ◽

Aspiration Pneumonia ◽

Japanese Patients ◽

Research Support ◽

Serious Adverse Events ◽

Chugai Pharmaceutical ◽

Post Marketing Surveillance ◽

Otsuka Pharmaceutical ◽

Post Marketing

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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