G.R. Burmester, MD, PhD, Berlin University Hospital, Berlin, Germany, presented data from 3 open-label trials that examined the effectiveness of adalimumab treatment in patients with ankylosing spondylitis (AS), rheumatoid arthritis (RA), or psoriatic arthritis (PsA) who had a history of anti-TNF therapy.

The objective of this post hoc analysis of data from the RHAPSODY (NCT00478660; AS), ReAct (NCT00650026; RA), and STEREO (NCT00235885; PsA) trials was to investigate the effectiveness and safety of adalimumab treatment in patients who had received prior anti-TNF therapy with etanercept or infliximab but did not have a satisfactory response. Patients who had prior TNF experience could enroll in the original studies only if infliximab had been discontinued ≥2 months before baseline and/or if etanercept had been discontinued ≥3 weeks before baseline in RHAPSODY and STEREO or ≥2 months before entry in ReAct. Subjects in these studies received adalimumab 40 mg subcutaneously every other week in addition to their current antirheumatic treatment regimens for 12 weeks.

Patients who had failed prior anti-TNF therapy with etanercept and/or infliximab achieved a significant clinical response with adalimumab, which was similar to the response of patients who were naïve to anti-TNF therapy.

After 12 weeks of treatment with adalimumab, patients with AS who previously were treated with etanercept and/or infliximab had a mean reduction in the BASDAI of 2.6 versus 3.5 for patients who had no prior anti-TNF therapy. Patients with RA who had previously received treatment with etanercept and/or infliximab had a mean reduction of 1.9 in DAS28 score versus 2.2 in patients who were not previously treated with a TNF inhibitor. Baseline disease characteristics and effectiveness data are shown in Table 1.

Adalimumab was well tolerated by patients with and without a history of prior anti-TNF therapy. Although the rate of serious adverse events was lower in anti-TNF-naïve patients (Table 2), the investigators suggested that this may have been due to the somewhat greater disease activity and level of disability in patients with prior anti-TNF therapy.

Prof. Burmester commented, “An increasing number of patients with rheumatic diseases, such as ankylosing spondylitis, rheumatoid arthritis, or psoriatic arthritis, are experiencing an inadequate response to, or are intolerant of, treatment with existing anti-TNFs, including etanercept or infliximab. The results of our study show that adalimumab offers new hope for those who have tried but have not responded well to other treatment options for their diseases.”