Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Dec;41(12):3735-3745.
doi: 10.1007/s10067-022-06325-6. Epub 2022 Aug 8.

Effect and safety profile of belimumab and tacrolimus combination therapy in thirty-three patients with systemic lupus erythematosus

Takehiro Nakai  1 , Sho Fukui  2   3   4 , Genki Kidoguchi  2 , Yukihiko Ikeda  2 , Ayako Kitada  2 , Atsushi Nomura  2 , Hiromichi Tamaki  2 , Mitsumasa Kishimoto  2   5 , Masato Okada  2
Affiliations

Effect and safety profile of belimumab and tacrolimus combination therapy in thirty-three patients with systemic lupus erythematosus

Takehiro Nakai et al. Clin Rheumatol. 2022 Dec.

Abstract

Introduction/objectives: Belimumab combined with mycophenolate mofetil has been proven to be effective for treating systemic lupus erythematosus (SLE) in several randomized controlled trials. Calcineurin inhibitors are also useful in controlling the activity of SLE. However, the safety and effectiveness of belimumab-calcineurin inhibitor combination therapy have not been addressed. Therefore, the current single-center retrospective study aimed to analyze the safety/efficacy profile of belimumab-tacrolimus (B-T) combination therapy in patients with SLE.

Method: Patients with SLE administered tacrolimus and belimumab during treatment were included in the study. Samples were analyzed for the drug retention rate, SLE flare rate, infection incidence rate, and glucocorticoid-sparing effect of the B-T combination therapy.

Results: Thirty-three patients with SLE were treated with B-T combination therapy at our institution. Four patients discontinued treatment due to insufficient response or adverse events. The drug retention rate was over 90% at week 52 and approximately 80% at day 1000. Only one patient developed serious infection. The lupus low disease activity state (LLDAS) achievement ratio was 9.1% on the day of initiation and improved to 64.0% at 52 weeks after initiation. SLE flares were observed in three patients (9.1%) in the first 52 weeks after initiation, and in five patients (15.2%) throughout the study period. A glucocorticoid-reducing effect was also observed in patients treated with B-T combination therapy.

Conclusions: In most patients with SLE, B-T combination therapy is well tolerated with a good efficacy profile and glucocorticoid-reducing effect. Thus, B-T combination therapy represents a feasible option for patients with refractory lupus. Key Points • The safety and effectiveness of belimumab-calcineurin inhibitor combination therapy have not been addressed. • The drug retention rate of belimumab-tacrolimus combination therapy was over 90% at week 52 and around 80% on day 1000 • Almost none of the patients suffered from severe infection after the initiation of belimumab-tacrolimus combination therapy. • Belimumab-tacrolimus combination therapy is efficacious in suppressing lupus activity and achieving LLDAS.

Keywords: Belimumab; Calcineurin inhibitor; Retrospective study; Systemic lupus erythematosus; Tacrolimus.

PubMed Disclaimer

Similar articles

See all similar articles

Cited by

References

    1. Hahn BH (2013) Belimumab for systemic lupus erythematosus. N Engl J Med 368:1528–1535. https://doi.org/10.1056/NEJMct1207259 - DOI - PubMed
    1. Petri M, Stohl W, Chatham W, McCune WJ, Chevrier M, Ryel J, Recta V, Zhong J, Freimuth W (2008) Association of plasma B lymphocyte stimulator levels and disease activity in systemic lupus erythematosus. Arthritis Rheum 58:2453–2459. https://doi.org/10.1002/art.23678 - DOI - PubMed
    1. Stohl W (2013) Future prospects in biologic therapy for systemic lupus erythematosus. Nat Rev Rheumatol 9:705–720. https://doi.org/10.1038/nrrheum.2013.136 - DOI - PubMed
    1. Ruggenenti P, Fervenza FC, Remuzzi G (2017) Treatment of membranous nephropathy: Time for a paradigm shift. Nat Rev Nephrol 13:563–579. https://doi.org/10.1038/nrneph.2017.92 - DOI - PubMed
    1. Navarra SV, Guzmán RM, Gallacher AE, Hall S, Levy RA, Jimenez RE, Li EK-M, Thomas M, Kim H-Y, León MG, Tanasescu C, Nasonov E, Lan J-L, Pineda L, Zhong ZJ, Freimuth W, Petri MA, BLISS-52 Study Group (2011) Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial. Lancet 377:721–731. https://doi.org/10.1016/S0140-6736(10)61354-2 - DOI - PubMed

MeSH terms

LinkOut - more resources