Evidence map›Paper›PMID 35939162›Full record

ArticleClinical rheumatology2022

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

Takehiro Nakai, Sho Fukui, Genki Kidoguchi, Yukihiko Ikeda, Ayako Kitada, Atsushi Nomura, Hiromichi Tamaki, Mitsumasa Kishimoto, Masato Okada

Abstract read
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In one paragraph

Article in Clinical rheumatology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
1.2field-weighted citation impact, top 21% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 2 institutions in 1 country.

Takehiro NakaiImmuno-Rheumatology Center, St. Luke's International Hospital, 9-1 Akashi-cho, Chuo-ku, Tokyo, Japan. nowhereman1106@outlook.jp.ORCID http://orcid.org/0000-0003-0588-9518
Sho FukuiImmuno-Rheumatology Center, St. Luke's International Hospital, 9-1 Akashi-cho, Chuo-ku, Tokyo, Japan.
Genki KidoguchiImmuno-Rheumatology Center, St. Luke's International Hospital, 9-1 Akashi-cho, Chuo-ku, Tokyo, Japan.
Yukihiko IkedaImmuno-Rheumatology Center, St. Luke's International Hospital, 9-1 Akashi-cho, Chuo-ku, Tokyo, Japan.
Ayako KitadaImmuno-Rheumatology Center, St. Luke's International Hospital, 9-1 Akashi-cho, Chuo-ku, Tokyo, Japan.
Atsushi NomuraImmuno-Rheumatology Center, St. Luke's International Hospital, 9-1 Akashi-cho, Chuo-ku, Tokyo, Japan.
Hiromichi TamakiImmuno-Rheumatology Center, St. Luke's International Hospital, 9-1 Akashi-cho, Chuo-ku, Tokyo, Japan.
Mitsumasa KishimotoImmuno-Rheumatology Center, St. Luke's International Hospital, 9-1 Akashi-cho, Chuo-ku, Tokyo, Japan.
Masato OkadaImmuno-Rheumatology Center, St. Luke's International Hospital, 9-1 Akashi-cho, Chuo-ku, Tokyo, Japan.
St. Luke's International Hospital · JPKyorin University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

INTRODUCTION/

objectivesBelimumab 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.

methodPatients 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.

resultsThirty-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.

conclusionsIn 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.

Indexed as

Lupus Erythematosus, SystemicTacrolimusAntibodies, Monoclonal, HumanizedCalcineurin InhibitorsGlucocorticoidsHumansImmunosuppressive AgentsRetrospective StudiesSeverity of Illness IndexTreatment OutcomeAntibodies, Monoclonal, HumanizedbelimumabCalcineurin InhibitorsGlucocorticoidsImmunosuppressive AgentsTacrolimusBelimumabCalcineurin inhibitorRetrospective studySystemic lupus erythematosusTacrolimus

Identifiers

PMID35939162
OpenAlexW4290635059

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.