Asian Spine J.  2022 Feb;16(1):99-106. 10.31616/asj.2020.0283.

Improvements in Intractable Lumbar and LowerExtremity Symptoms after Systemic Administration of Tocilizumab, an Anti-interleukin-6 Receptor Antibody

Affiliations
  • 1Department of Orthopaedic Surgery, Sainou Hospital, Toyama, Japan
  • 1Department of Orthopaedic Surgery, Sainou Hospital, Toyama, Japan
  • 2Department of Orthopaedic Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan
  • 2Department of Orthopaedic Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan
  • 3Center for Frontier Medical Engineering, Chiba University, Chiba, Japan
  • 3Center for Frontier Medical Engineering, Chiba University, Chiba, Japan
  • 4Department of Orthopaedic Surgery, School of Medicine, Kitasato University, Sagamihara, Japan
  • 4Department of Orthopaedic Surgery, School of Medicine, Kitasato University, Sagamihara, Japan
  • 5Department of Environmental Medicine, Graduate School of Medicine, Chiba University, Chiba, Japan
  • 5Department of Environmental Medicine, Graduate School of Medicine, Chiba University, Chiba, Japan
  • 6Department of Orthopaedic Surgery, Kanazawa Hospital, Yokohama, Japan
  • 6Department of Orthopaedic Surgery, Kanazawa Hospital, Yokohama, Japan
  • 7Department of Orthopaedic Surgery, Chiba Children’s Hospital, Chiba, Japan
  • 7Department of Orthopaedic Surgery, Chiba Children’s Hospital, Chiba, Japan
  • 8Department of Orthopaedic Surgery, Chiba Prefectural Sawara Hospital, Katori, Japan
  • 8Department of Orthopaedic Surgery, Chiba Prefectural Sawara Hospital, Katori, Japan
  • 9Department of Orthopaedic Surgery, Kohnodai Hospital, Ichikawa, Japan
  • 9Department of Orthopaedic Surgery, Kohnodai Hospital, Ichikawa, Japan
  • 10Department of Orthopaedic Surgery, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan
  • 10Department of Orthopaedic Surgery, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan
  • 11Department of Orthopaedic Surgery, Eastern Chiba Medical Center, Togane, Japan
  • 11Department of Orthopaedic Surgery, Eastern Chiba Medical Center, Togane, Japan
  • 12Department of Orthopaedic Surgery, St. Marianna University School of Medicine, Kawasaki, Japan
  • 12Department of Orthopaedic Surgery, St. Marianna University School of Medicine, Kawasaki, Japan
  • 13Department of Orthopaedic Surgery, Chiba Cancer Center, Chiba, Japan
  • 13Department of Orthopaedic Surgery, Chiba Cancer Center, Chiba, Japan
  • 14Department of Orthopaedic Surgery, Toho University Sakura Medical Center, Sakura, Japan
  • 14Department of Orthopaedic Surgery, Toho University Sakura Medical Center, Sakura, Japan

Abstract

Study Design: Prospective cohort study (open-label, single-arm, and non-blinded). Purpose: This study aims to determine the effects of systemic administration of tocilizumab, an anti-interleukin-6 (IL-6) receptor antibody on refractory low back pain and leg symptoms. Overview of Literature: IL-6 overexpression is associated with neuropathic pain pathogenesis, which is potentially followed by chronic low back pain, including leg pain and numbness. This finding suggest that inhibition of IL-6 at the site of pain or in the transmission pathway could provide novel therapeutic targets for chronic low back pain.
Methods
This prospective, single-arm study included 11 patients (eight men; mean age, 62.7 years) with ≥3-months’ chronic pain history due to lumbar disease. Subcutaneous TCZ injections were administered twice, at a 2-week interval. We evaluated low back pain, leg pain, and leg numbness using numeric rating scales and the Oswestry Disability Index (ODI; baseline and 6 months postinjection); serum IL-6 and tumor necrosis factor-α levels (baseline and 1 month postinjection); and clinical adverse events.
Results
Intractable symptoms reduced after TCZ administration. Low back pain improved for 6 months. Improvements in leg pain and numbness peaked at 4 and 1 month, respectively. Improvements in ODI were significant at 1 month and peaked at 4 months. Serum IL-6 was increased at 1 month. IL-6 responders (i.e., patients with IL-6 increases >10 pg/mL) showed particularly significant improvements in leg pain at 2 weeks, 1 month, and 2 months compared with nonresponders. We observed no apparent adverse events.
Conclusions
Systemic TCZ administration improved symptoms effectively for 6 months, with peak improvements at 1–4 months and no adverse events. Changing serum IL-6 levels correlated with leg pain improvements; further studies are warranted to elucidate the mechanistic connections between lumbar disorders and inflammatory cytokines.

Keyword

Interleukin-6; Interleukin-6; Chronic pain; Chronic pain; Low back pain; Low back pain; Analgesic; Analgesic; Tocilizumab; Tocilizumab
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