RCT TF Etanercept to Tx L/S HNP

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Randomized, Double-blind, Placebo-Controlled, Trial of Transforaminal Epidural Etanercept for the Treatment of Symptomatic Lumbar Disc Herniation[URL='http://www.ncbi.nlm.nih.gov/pubmed/24165696#']
Spine (Phila Pa 1976). 2013 Nov 1;38(23):1986-94.
Freeman BJ, Ludbrook GL, Hall S, Cousins M, Mitchell B, Jaros M, Wyand M, Gorman JR.[/URL]
Source
*Royal Adelaide Hospital, Adelaide, Australia †University of Adelaide, Adelaide, Australia ‡Cabrini Medical Centre, Melbourne, Australia §Royal North Shore Hospital, Sydney, Australia ¶Metro Spinal Clinic, Melbourne, Australia ‖Summit Analytical, Chicago, IL; and **BioAssets Development Corporation, Wellesley, MA.

Abstract
STUDY DESIGN:
Multicenter, randomized, double-blind, placebo-controlled trial.

OBJECTIVE:
To examine the safety and efficacy of three different doses of the tumor necrosis factor alpha (TNF-α) inhibitor etanercept versus placebo for the treatment of symptomatic lumbar disc herniation (LDH).

SUMMARY OF BACKGROUND DATA:
TNF-α is considered to be a major cause of radicular leg pain associated with symptomatic LDH. Systemic administration of TNF-α inhibitors for sciatica has indicated a trend toward efficacy.

METHODS:
Forty-nine subjects aged between 18 and 70 years, with persistent lumbosacral radicular pain secondary to LDH, and an average leg pain intensity of 5/10 or more were randomized to 1 of 4 groups: 0.5-mg, 2.5-mg, 12.5-mg etanercept, or placebo. Subjects received 2 transforaminal epidural injections, 2 weeks apart, and were assessed for efficacy up to 26 weeks after the second injection. The primary outcome measure was the change in mean daily worst leg pain (WLP). Secondary outcomes included average leg pain, worst back pain, average back pain, in-clinic pain, Oswestry Disability Index, patient global impression of change, and tolerability.

RESULTS:
Forty-three of the 49 randomized patients completed the study. Patients receiving 0.5-mg etanercept showed a clinically and statistically significant (P< 0.1) reduction in mean daily WLP compared with the placebo cohort from 2 to 26 weeks for both the per protocol population (-5.13 vs. -1.95; P= 0.066) and the intention-to-treat population (-4.40 vs. -1.84; P= 0.058). Fifty percent of these subjects reported a 100% reduction in WLP 4 weeks post-treatment compared with 0% of subjects in the placebo cohort. Improvements in all secondary outcomes were also observed in the 0.5-mg etanercept cohort. The overall incidence of adverse events was similar in placebo and all etanercept cohorts.

CONCLUSION:
Two transforaminal injections of etanercept provided clinically significant reductions in mean daily WLP and worst back pain compared with placebo for subjects with symptomatic LDH. Epidural etanercept may offer patients with sciatica a safe and effective nonoperative treatment.Level of Evidence: N/A.

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Ann Intern Med. 2012 Apr 17;156(8):551-9. doi: 10.7326/0003-4819-156-8-201204170-00002.
Epidural steroids, etanercept, or saline in subacute sciatica: a multicenter, randomized trial.
Cohen SP, White RL, Kurihara C, Larkin TM, Chang A, Griffith SR, Gilligan C, Larkin R, Morlando B, Pasquina PF, Yaksh TL, Nguyen C.
Source
Johns Hopkins School of Medicine, Baltimore, Maryland, USA. [email protected]

Abstract
BACKGROUND:
Perineural inhibitors of tumor necrosis factor have recently generated intense interest as an alternative to epidural steroid injections for lumbosacral radiculopathy.

OBJECTIVE:
To evaluate whether epidural steroids, etanercept, or saline better improves pain and function in adults with lumbosacral radiculopathy.

DESIGN:
A multicenter, 3-group, randomized, placebo-controlled trial conducted from 2008 to 2011. Randomization was computer-generated and stratified by site. Pharmacists prepared the syringes. Patients, treating physicians, and nurses assessing outcomes were blinded to treatment assignment. (ClinicalTrials.gov registration number: NCT00733096)

SETTING:
Military and civilian treatment centers.

PATIENTS:
84 adults with lumbosacral radiculopathy of less than 6 months' duration.

INTERVENTION:
2 epidural injections of steroids, etanercept, or saline, mixed with bupivacaine and separated by 2 weeks.

MEASUREMENTS:
The primary outcome measure was leg pain 1 month after the second injection. All patients had 1-month follow-up visits; patients whose condition improved remained blinded for the 6-month study period.

RESULTS:
The group that received epidural steroids had greater reductions in the primary outcome measure than those who received saline (mean difference, -1.26 [95% CI, -2.79 to 0.27]; P = 0.11) or etanercept (mean difference, -1.01 [CI, -2.60 to 0.58]; P = 0.21). For back pain, smaller differences favoring steroids compared with saline (mean difference, -0.52 [CI, -1.85 to 0.81]; P = 0.44) and etanercept (mean difference, -0.92 [CI,-2.28 to 0.44]; P = 0.18) were observed. The largest differences were noted for functional capacity, in which etanercept fared worse than the other treatments: steroids vs. etanercept (mean difference, -16.16 [CI, -26.05 to -6.27]; P = 0.002), steroids vs. saline (mean difference, -5.87 [CI, -15.59 to 3.85]; P = 0.23), and etanercept vs. saline (mean difference, 10.29 [CI, 0.55 to 20.04]; P = 0.04). More patients treated with epidural steroids (75%) reported 50% or greater leg pain relief and a positive global perceived effect at 1 month than those who received saline (50%) or etanercept(42%) (P = 0.09).

LIMITATION:
Short-term follow-up, small sample size, and a possibly subtherapeutic dose of etanercept.

CONCLUSION:
Epidural steroid injections may provide modest short-term pain relief for some adults with lumbosacral radiculopathy, but larger studies with longer follow-up are needed to confirm their benefits.

PRIMARY FUNDING SOURCE:
The John P. Murtha Neuroscience and Pain Institute, International Spinal Intervention Society, and Center for Rehabilitation Sciences Research.