UCB published results from a post hoc analysis of the RAPID 2 study in the Annals of Rheumatic Diseases, which showed Cimzia, the only approved PEGylated anti-TNF, plus methotrexate (MTX) provided rapid relief from a broad range of symptoms associated with the burden of moderate to severe active rheumatoid arthritis (RA). Adult patients treated with Cimzia that achieved early responses were found to have an increased chance of achieving longer-term outcomes.
In the RAPID 2 study, patients with active RA with inadequate responses to MTX therapy were randomized to receive certolizumab pegol (400mg at weeks 0, 2 and 4 followed by 200mg or 400mg every two weeks) plus MTX, or placebo together with MTX for 24 weeks. The primary outcome measure was ACR 20 response at week 24.
At week 24, significantly more patients in the certolizumab pegol treatment groups reported improvements greater than or equal to MCID in all six PROs (pain, fatigue, patient's global assessment of disease (PtGA), physical function by HAQ, and HRQOL by SF-36 physical and mental component summary scores). The beneficial effects of certolizumab pegol were similar between the 200mg and 400mg dose levels with no significant difference between treatment groups in any PROs.
Furthermore, at week 24, 63% of certolizumab pegol 200mg treated patients reported clinically meaningful improvements in greater than or equal to 1 PRO compared with 13% in placebo groups, and approximately 23% of all certolizumab pegol treated patients reported clinically meaningful improvements in all six PROs compared with 3% in placebo groups.