Asian Spine Journal (Feb 2022)

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

  • Takeshi Sainoh,
  • Sumihisa Orita,
  • Masayuki Miyagi,
  • Miyako Suzuki-Narita,
  • Yoshihiro Sakuma,
  • Yasuhiro Oikawa,
  • Go Kubota,
  • Jun Sato,
  • Yasuhiro Shiga,
  • Kazuki Fujimoto,
  • Yawara Eguchi,
  • Masao Koda,
  • Yasuchika Aoki,
  • Tsutomu Akazawa,
  • Takeo Furuya,
  • Junichi Nakamura,
  • Hiroshi Takahashi,
  • Satoshi Maki,
  • Masahiro Inoue,
  • Hideyuki Kinoshita,
  • Masaki Norimoto,
  • Takashi Sato,
  • Masashi Sato,
  • Masahiro Suzuki,
  • Keigo Enomoto,
  • Hiromitsu Takaoka,
  • Norichika Mizuki,
  • Takashi Hozumi,
  • Ryuto Tsuchiya,
  • Geundong Kim,
  • Takuma Otagiri,
  • Tomohito Mukaihata,
  • Takahisa Hishiya,
  • Seiji Ohtori,
  • Kazuhide Inage

DOI
https://doi.org/10.31616/asj.2020.0283
Journal volume & issue
Vol. 16, no. 1
pp. 99 – 106

Abstract

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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.

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