The patient self-report instruments used in RAPID 1 and FAST4WARD to assess the impact of CIMZIA on PROs have been shown to be valid and reliable in prior studies involving patients with rheumatoid arthritis (RA).1 These instruments included1,2:
In RAPID 1 (52-week study), the SF-36 was completed at baseline, week 12, and every 12 weeks thereafter to study completion or patient withdrawal.1 All other PROs were measured at baseline, weeks 1 and 2, and then every 2 weeks until week 20, followed by every 4 weeks until study completion or patient withdrawal.1 In FAST4WARD (24-week monotherapy study), all PROs were assessed at baseline and at weeks 1, 2, 4, 8, 12, 16, 20, and 24.2
In all 4 CIMZIA RA pivotal trials, CIMZIA-treated patients achieved greater improvements compared with placebo in physical function as assessed by the HAQ-DI.3
Patients treated with CIMZIA 200 mg every 2 weeks in RAPID 1 experienced clinically significant reductions in pain, fatigue, and disability at week 24, with 57% of patients reporting reductions in pain, 55% reporting reductions in fatigue, and 52% reporting improvements in physical functioning. At week 52, 52% of patients reported reductions in pain, 49% reported reductions in fatigue, and 47% reported improvements in physical functioning.1
In the RAPID 1 study, patients’ self-assessed levels of disability, arthritis pain, and fatigue were obtained at baseline and throughout the study. Patients treated with CIMZIA plus methotrexate (MTX) reported clinically meaningful improvements in pain, fatigue, and disability as early as Week 1 and Week 4.4,5
At week 12, CIMZIA patients in RAPID 1 achieved statistically significant reductions in HRQoL measures.1 Improvements above the threshold of MCID (minimal clinically important difference) were evident in all SF-36 domains at 12 weeks and were sustained through the length of the 52-week study.1
Important Safety Information Use of TNF blockers, including CIMZIA, may increase the risk of reactivation of hepatitis B virus.
Treatment with TNF blockers, including CIMZIA, may rarely result in new onset or exacerbation of clinical symptoms and/or radiographic evidence of central or peripheral nervous system demyelinating disease, as well as the development of a lupus-like syndrome.
CIMZIA 400 mg every 4 weeks also produced significant and sustained improvement over placebo in PROs assessed in FAST4WARD, including pain, fatigue, and disability. Significant reductions in pain, fatigue, and disability were evident at week 1.2 These reductions were sustained out to week 24. Additionally, at week 24, a clinically meaningful improvement in disability was seen in 49% of patients treated with CIMZIA, 47% reported meaningful improvement in pain, and 46% reported meaningful improvement in fatigue.2
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