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Arthritis Research and Therapy

, 14:R206

First Online: 04 October 2012Received: 28 March 2012Revised: 04 July 2012Accepted: 04 October 2012

Abstract

IntroductionInflammation associated with synovial expression of TNFα is a recognised feature of osteoarthritis OA, although no studies have yet reported beneficial effects of anti-TNFα therapy on clinical manifestations of inflammation in OA.

MethodsWe conducted an open-label evaluation of adalimumab over 12 weeks in 20 patients with OA of the knee and evidence of effusion clinically. Inclusion criteria included daily knee pain for the month preceding study enrolment and a summed pain score of 125 to 400 mm visual analogue scale on the Western Ontario and McMaster University Osteoarthritis Index WOMAC pain subscale. The primary outcome was the Osteoarthritis Research Society International-Outcome Measures in Rheumatology Clinical Trials OARSI-OMERACT response criterion at week 12. Secondary outcomes included the WOMAC pain score 20% and 50% improvement, WOMAC stiffness and function scores, patient and physician global visual analogue scale, as well as target joint swelling.

ResultsTreatment was well tolerated and completed by 17 patients with withdrawals unrelated to lack of efficacy or adverse events. By intention to treat, an OARSI-OMERACT response was recorded in 14 70% patients. WOMAC pain 20% and 50% responses were recorded in 14 70% patients and eight 40% patients, respectively. Significant improvement was observed in mean WOMAC pain, stiffness, function, physician and patient global, as well as target joint swelling at 12 weeks P < 0.0001 for all. After treatment discontinuation, 16 patients were available for assessment at 22 weeks and OARSI-OMERACT response compared with baseline was still evident in 10 50% patients.

ConclusionTargeting TNFα may be of therapeutic benefit in OA and requires further evaluation in controlled trials.

Trial registrationClinicalTrials.gov: NCT00686439.

AbbreviationsILinterleukin

MRImagnetic resonance imaging

NSAIDnonsteroidal anti-inflammatory drug

OAosteoarthritis

OARSI-OMERACTOsteoarthritis Research Society International-Outcome Measures in Rheumatology Clinical trials

SDstandard deviation

TNFtumour necrosis factor

VASvisual analogue scale

WOMACWestern Ontario and McMaster University Osteoarthritis Index.

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Author: Walter P Maksymowych - Anthony S Russell - Peter Chiu - Alex Yan - Niall Jones - Tracey Clare - Robert GW Lambert

Source: https://link.springer.com/







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