Adalimumab did not provide significant relief of pain, synovitis in hand OA

Patients with erosive hand osteoarthritis treated with adalimumab experienced no significant alleviation of pain, synovitis or bone marrow lesions compared with patients treated with placebo, according to results presented at a meeting.

“The results from our trial showed that adalimumab was no different to placebo to alleviate pain, synovitis or [bone marrow lesions] BMLs in patients with erosive hand osteoarthritis presenting with MRI-detected synovitis,” Dawn Aitken, PhD, said.

Aitken and colleagues randomly assigned 43 patients (77% were women) with erosive hand osteoarthritis (OA) to receive for 12 weeks either 40 mg adalimumab every other week or placebo. This was followed by an 8-week washout period and a second period in which patients received the converse treatment.

She noted the primary outcome measure used was change in VAS hand pain score over 12 weeks and secondary outcomes were the change in Australian/Canadian pain, function and stiffness score at 4 weeks, 8 weeks and 12 weeks; change in VAS pain score at 4 weeks and 8 weeks; and change in MRI-detected synovitis and BMLs at 12 weeks using the Outcome Measures in Rheumatology hand OA MRI score or the thumb base OA MRI score.

Results showed the change in VAS pain score was no different for the adalimumab group and the placebo group.

“The adalimumab group had a decrease in VAS pain of 3 and the placebo [group] had a decrease of –0.7 with a mean treatment effect of –2.3, which was not clinically or statistically significant,” Aitken said.

The study had no placebo effect and the VAS pain score changes were small regardless of the order in which patients received the two treatments.

“There was no clinically or statistically significant difference found for any of our secondary outcomes, including patient-reported outcomes and our MRI findings,” Aitken said. “There are small changes in synovitis and bone marrow lesion scores in both groups.”

Missing data due to patients who withdrew from the study and the crossover study design are potential limitations to this work. However, supplementary analysis using the last observation carried forward for the patients with missing primary outcome data at 12 weeks supported the study findings, according to Aitken.

“While crossover trials can be problematic due to carry-over treatment effects, our trial did not show any carry-over treatment effects as there was no real difference between the placebo and the active group in either treatment period,” she said. – by Casey Tingle

Reference:

Aitken D, et al. Paper #3. Presented at: Osteoarthritis Research Society International World Congress; April 27-30, 2017; Las Vegas.

For more information:

Dawn Aitken, PhD, can be reached at Menzies Institute for Medical Research, Medical Science Precinct, 17 Liverpool St., Hobart Tasmania 7000 Australia; email: dawn.aitken@utas.edu.au.

Disclosure: The study was supported by AbbVie.