Dataset Information

Subcutaneous Tocilizumab May Be Effective in Refractory Fibromyalgia Patients.

ABSTRACT:

Introduction

Fibromyalgia (FM) is a chronic disorder characterized by widespread pain with an enormous symptom burden. Its treatment efficacy is limited. Its pathogenesis involves immune dysregulation, which includes interleukin-6 (IL-6) production.

Methods

We herein reported a case series of FM patients receiving subcutaneous tocilizumab at our institution. FM symptoms were evaluated by the revised Fibromyalgia Impact Questionnaire (FIQR), which included pain level, and the fibromyalgianess scale based on the 2016 criteria of the American College of Rheumatology (ACR). FM symptoms were compared using the Wilcoxon signed-rank test. Neutrophils from primary FM patients and matched healthy controls were also isolated for transcriptome analysis.

Results

We presented a total of two primary and four secondary FM patients who had received subcutaneous tocilizumab for a minimum of 12 weeks. All patients had severe symptoms despite standard treatments. Patients' FIQR and fibromyalgianess both dropped at 4 and 12 weeks. Four (67%) of them reached a pain reduction of ≥30% at 4 weeks, and three (50%) reached a pain reduction of ≥30% at 12 weeks. Possible differentially expressed genes were identified in primary FM patients when compared with controls and after tocilizumab treatment.

Conclusions

FM patients likely benefited from subcutaneous tocilizumab therapy. A randomized controlled trial is needed to verify its efficacy.

SUBMITTER: Tang KT

PROVIDER: S-EPMC10376766 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature

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Subcutaneous Tocilizumab May Be Effective in Refractory Fibromyalgia Patients.

Tang Kuo-Tung KT Liao Tsai-Ling TL Chen Yi-Hsing YH Chen Der-Yuan DY Lai Kou-Lung KL

Biomedicines 20230621 7

<h4>Introduction</h4>Fibromyalgia (FM) is a chronic disorder characterized by widespread pain with an enormous symptom burden. Its treatment efficacy is limited. Its pathogenesis involves immune dysregulation, which includes interleukin-6 (IL-6) production.<h4>Methods</h4>We herein reported a case series of FM patients receiving subcutaneous tocilizumab at our institution. FM symptoms were evaluated by the revised Fibromyalgia Impact Questionnaire (FIQR), which included pain level, and the fibro ...[more]

PMID: 37509414

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Project description:BackgroundWhile targeting the interleukin-6 receptor (IL-6R) through the use of sarilumab (SAR) or tocilizumab (TCZ) has become a major therapeutic approach for rheumatoid arthritis (RA), direct comparisons between IL-6R inhibitors (IL-6Ris) for treating RA have not been conducted. We aimed to compare the effectiveness of subcutaneous sarilumab (SAR-SC), subcutaneous tocilizumab (TCZ-SC), and intravenous TCZ (TCZ-IV) against RA in a multicenter cohort study.MethodsWithin the target trial emulation framework, an incident new-user and active-comparator cohort design was used. The source population was the entire cohort of a multicenter prospective study (the ANSWER cohort study) in Japan from 2009 to 2023. We consecutively included patients with IL-6Ri-naïve RA who initiated treatment with SAR-SC 200 mg biweekly, TCZ-SC 162 mg biweekly, or TCZ-IV 8 mg/kg every 4 weeks as the approved starting dose and dosing interval at baseline. The primary outcome of interest was the change in the clinical disease activity index (CDAI) at 24 weeks.ResultsIn total, 1001 IL-6Ri-naïve patients were included (SAR-SC 200 mg biweekly, 201 patients; TCZ-SC 162 mg biweekly, 546; TCZ-IV 8 mg/kg every 4 week, 254). The improvement in CDAI at 24 weeks (primary outcome) was statistically significantly greater in the SAR-SC group than in the TCZ-SC group (-2.53, 95% confidence interval (CI): -4.38 to -0.69, p = 0.007), but that in TCZ-IV was not significantly different from that in TCZ-SC (1.00, 95% CI: -0.68 to 2.69, p = 0.243). Similar results were noted regarding the changes in CDAI at weeks 4, 12, and 48. The retention rates at 48 weeks in SAR-SC and TCZ-IV did not significantly differ from that in TCZ-SC.ConclusionsSAR-SC 200 mg biweekly initiation was associated with a statistically significantly greater decrease in disease activity than TCZ-SC 162 mg biweekly in IL-6Ri-naïve patients with RA. In contrast, no statistically significant differences were identified between TCZ-IV 8 mg/kg every 4 week and TCZ-SC 162 mg biweekly. However, the effect size of our findings should necessitate careful consideration of the cost difference between TCZ-SC 162 mg biweekly including its biosimilars and SAR-SC 200 mg biweekly.

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Dataset Information

Subcutaneous Tocilizumab May Be Effective in Refractory Fibromyalgia Patients.

Introduction

Methods

Results

Conclusions

Publications

Subcutaneous Tocilizumab May Be Effective in Refractory Fibromyalgia Patients.

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