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Treatment with adalimumab (Humira) was unsuccessful in providing pain relief for hand osteoarthritis (OA), a randomized multicenter trial found.

Among patients with hand OA who had not previously responded to analgesics and nonsteroidal anti-inflammatory drugs, 35.1% of those given adalimumab experienced a 50% improvement in pain at week six, as did 27.3% of those given placebo, according to Xavier Chevalier, MD, of Henri Mondor Hospital in Creteil, France, and colleagues.

This gave a (95% CI 0.82-1.55, P=0.47), the researchers reported online in Annals of the Rheumatic Diseases.

Osteoarthritis of the hand is the most common type of OA, particularly among older women, and some patients experience erosive changes and significant pain and disability even with

"Therefore, there is a real need for an emerging effective therapy in hand OA where the impact on the patient's daily quality of life could be as severe as in rheumatoid arthritis," stated Chevalier and colleagues.

Targeting tumor necrosis factor (TNF) in this clinical circumstance was reasonable, according to the authors, because this proinflammatory cytokine has an important role in the degradation of cartilage in OA and upregulates neurotrophin nerve growth factor, which is involved in OA pain mediation.

In addition, TNF inhibition has proven highly successful in alleviating symptoms and preserving structure in rheumatoid and psoriatic arthritis.

Therefore, to assess the possibility that this strategy also could be helpful in hand OA, the researchers enrolled 78 patients whose mean age was 63 and whose mean body mass index was 25 kg/m².

A total of 85% were women, and baseline pain score on a 100-mm visual analog scale was 65, with a mean symptom duration of 13.5 years.

The treatment consisted of two 40-mg subcutaneous injections of the TNF inhibitor adalimumab or placebo, 2 weeks apart. Patients were then followed for 6 months.

By week six, the difference between the treatment and placebo groups on change in pain score was -2.5 mm (95% CI minus 14-9, P=0.67), which was "far below the level of clinical relevance," the researchers commented.

The difference in pain scores at week 26 was -1.4 mm (95% CI minus 13-10.1, P=0.80).

Among various other secondary endpoints, the only difference was in the number of swollen joints at week 26 among adalimumab-treated patients (-1.9, 95% CI minus 3.2-minus 0.6, P=0.006).

During the course of the study, 68% of patients receiving adalimumab required analgesics, as did 70% of those given placebo (P=0.85).

The researchers also evaluated the effects of treatment on biomarkers including C-reactive protein, interleukin (IL)-1, IL-6, and TNF alpha, and again found no differences in median change from baseline between the adalimumab and placebo groups at week six.

Adverse events were similar, occurring overall in 75.6% of the adalimumab group and 73% of the placebo group. Severe events occurred in 9.8% and 5.4% of the two groups, respectively.

"All these data strongly suggest that pain and disability in hand OA are not TNF alpha-dependent," the authors stated. Accordingly, other treatment targets for hand OA, such as IL-1 or IL-6, should be considered, they suggested.

"Though the current study is negative and does not support our initial expectation, we still need therapeutic solutions for these patients," the authors wrote.

This ongoing need is heightened by the observation in that patients with hand OA perceive inadequate appreciation of their pain and disability by clinicians.

A limitation of the study was the possibility that two injections of adalimumab were insufficient.

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