Tumor necrosis factor-alpha monoclonal antibody, infliximab, used to manage severe sciatica.
METHODS
An open-label study was conducted.


OBJECTIVE
To evaluate the efficacy and safety of infliximab, a monoclonal chimeric antibody, against tumor necrosis factor-alpha (TNFalpha) for the treatment of severe sciatica.


BACKGROUND
Evidence from animal studies indicates that TNFalpha plays a role in the pathophysiology of sciatica. Anti-TNFalpha therapy has not been previously evaluated in sciatic patients.


METHODS
In this study, 10 patients with disc herniation-induced severe sciatica received infliximab (Remicade 3 mg/kg) intravenously over 2 hours. The outcome was assessed at 1 hour, 1 week, 2 weeks, 1 month, and 3 months after the infusion and compared to historical control subjects consisting of 62 patients who received saline in a trial of periradicular infiltration for sciatica. Leg pain was the primary outcome, with more than a 75% decrease from the baseline score constituting a painless state. Fisher's exact test and repeated measures analysis of variance were used for statistical analysis.


RESULTS
At 1 hour after the infusion, leg pain had decreased by 50%. At 2 weeks, 60% of the patients in the infliximab group were painless, as compared with 16% of the control patients (P = 0.006). The difference was sustained at 3 months (90% vs 46%; P = 0.014). Infliximab was superior over the whole follow-up period in terms of leg pain (P = 0.003) and back-related disability (P = 0.004). At 1 month, every patient in the infliximab group had returned to work, whereas 38% of the control subjects still were on sick leave (P = 0.02). None of the patients treated with infliximab underwent surgery during the follow-up period. No immediate or delayed adverse drug reactions and no adverse effects related to medication were observed.


CONCLUSIONS
Anti-TNFalpha therapy is a promising treatment option for sciatica. There is an urgent need for a randomized controlled trial to evaluate whether thesepromising early results can be confirmed.
Karppinen
Jaro
J
Department of Physical Medicine and Rehabilitation, Oulu University Hospital, Finland. jaro.karppinen@occuphealth.fi
Korhonen
Timo
T
Malmivaara
Antti
A
Paimela
Leena
L
Kyllönen
Eero
E
Lindgren
Karl-August
KA
Rantanen
Pekka
P
Tervonen
Osmo
O
Niinimäki
Jaakko
J
Seitsalo
Seppo
S
Hurri
Heikki
H
D000328:Adult; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000069285:Infliximab; D007262:Infusions, Intravenous; D007405:Intervertebral Disc Displacement / Q000150:complications; D008297:Male; D008875:Middle Aged; D012585:Sciatica / Q000188:drug therapy* / Q000209:etiology / Q000276:immunology*; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors / Q000276:immunology*
D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab