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

• Sainoh T
• Sainoh T
• Orita S
• Orita S
• Miyagi M
• Miyagi M
• Suzuki-Narita M
• Suzuki-Narita M
• Sakuma Y
• Sakuma Y
• Oikawa Y
• Oikawa Y
• Kubota G
• Kubota G
• Sato J
• Sato J
• Shiga Y
• Shiga Y
• Fujimoto K
• Fujimoto K
• Eguchi Y
• Eguchi Y
• Koda M
• Koda M
• Aoki Y
• Aoki Y
• Akazawa T
• Akazawa T
• Furuya T
• Furuya T
• Nakamura J
• Nakamura J
• Takahashi H
• Takahashi H
• Maki S
• Maki S
• Inoue M
• Inoue M
• Kinoshita H
• Kinoshita H
• Norimoto M
• Norimoto M
• Sato T
• Sato T
• Sato M
• Sato M
• Suzuki M
• Suzuki M
• Enomoto K
• Enomoto K
• Takaoka H
• Takaoka H
• Mizuki N
• Mizuki N
• Hozumi T
• Hozumi T
• Tsuchiya R
• Tsuchiya R
• Kim G
• Kim G
• Otagiri T
• Otagiri T
• Mukaihata T
• Mukaihata T
• Hishiya T
• Hishiya T
• Ohtori S
• Ohtori S
• Inage K
• Inage K

• KMID: 2526585
• DOI: http://doi.org/10.31616/asj.2020.0283

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