The long-term safety and tolerability of anifrolumab for patients with systemic lupus erythematosus in Japan: TULIP-LTE subgroup analysis

Author:

Tanaka Yoshiya1ORCID,Atsumi Tatsuya2,Okada Masato3,Miyamura Tomoya4,Ishii Tomonori5,Nishiyama Susumu6,Matsumura Ryutaro7,Kawakami Atsushi8,Hayashi Nobuya9,Abreu Gabriel10,Yavuz Sule11,Lindholm Catharina12,Al-Mossawi Hussein13,Takeuchi Tsutomu14

Affiliation:

1. First Department of Internal Medicine, University of Occupational and Environmental Health, Japan , Kitakyushu, Japan

2. Department of Rheumatology, Endocrinology, and Nephrology, Hokkaido University , Sapporo, Japan

3. Immuno-Rheumatology Center, St Luke’s International Hospital , Tokyo, Japan

4. Department of Internal Medicine and Rheumatology, National Hospital Organization Kyushu Medical Center , Fukuoka, Japan

5. Department of Hematology and Rheumatology, Tohoku University Hospital , Miyagi, Japan

6. Rheumatic Disease Center, Kurashiki Medical Center , Kurashiki, Japan

7. Department of Rheumatology, National Hospital Organization, Chiba-East Hospital , Chiba, Japan

8. Department of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences , Nagasaki, Japan

9. Japan R&D, AstraZeneca K.K. , Osaka, Japan

10. Biometrics, Late Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca , Gothenburg, Sweden

11. Clinical Development, Late Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca , Gaithersburg, United States of America

12. Clinical Development, Late Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca , Gothenburg, Sweden

13. Clinical Development, Late Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca , Cambridge, UK

14. Department of Internal Medicine, Keio University School of Medicine, Tokyo, and Saitama Medical University , Saitama, Japan

Abstract

ABSTRACT Objectives Evaluate the long-term safety and tolerability of anifrolumab 300 mg, alongside standard therapy, in patients from Japan with systemic lupus erythematosus (SLE) in the TULIP-LTE trial (NCT02794285). Methods TULIP-LTE was a 3-year, randomized, double-blind, placebo-controlled long-term extension (LTE) of the TULIP trials. The primary safety outcome included serious adverse events (SAEs) and AEs of special interest (AESIs) during the LTE period. Exploratory efficacy outcomes included SLE Disease Activity Index 2000 (SLEDAI-2 K) scores and glucocorticoid use. We performed a post hoc subgroup analysis of patients who enrolled in Japan. Results Exposure-adjusted incidence rates of SAEs during the LTE and follow-up for patients receiving anifrolumab 300 mg (n = 21) were 8.7 per 100 patient-years; AESIs included influenza (6.9) and herpes zoster (3.5). One of three patients receiving placebo had an SAE (13.9). One patient per group discontinued due to an AE. There were no deaths. During the TULIP + LTE period, patients receiving anifrolumab 300 mg (n = 24) had sustained reduction from baseline in mean SLEDAI-2 K scores and cumulative glucocorticoid dosage. Conclusions Anifrolumab 300 mg showed a favourable benefit-risk profile for the long-term treatment of adult patients with moderate to severe SLE from Japan, with safety, tolerability, and efficacy profiles consistent with the overall population.

Publisher

Oxford University Press (OUP)

Subject

Rheumatology

Reference29 articles.

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4. Factors associated with damage accrual in patients with systemic lupus erythematosus: results from the Systemic Lupus International Collaborating Clinics (SLICC) inception cohort;Bruce;Ann Rheum Dis,2015

5. The effect of ethnicity and genetic ancestry on the epidemiology, clinical features and outcome of systemic lupus erythematosus;Lewis;Rheumatology (Oxford),2017

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