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Clinical trial data showed a rapid response to CIMZIA in patients with moderate to severe rheumatoid arthritis, with sustained response at 24 and 52 weeks.1,2

CIMZIA: Summary of pivotal phase 3 trial results in
rheumatoid arthritis

The efficacy and safety of CIMZIA were assessed in 4 randomized, placebo-controlled, double-blind studies in adult patients with moderately to severely active rheumatoid arthritis (RA).3 Three of these studies—RAPID 1, RAPID 2, and FAST4WARD—are described here.

RAPID 1 and RAPID 2 compared CIMZIA 200 mg or 400 mg every 2 weeks, following an induction dose of 400 mg at weeks 0, 2, and 4, plus methotrexate (MTX) to placebo plus MTX in patients with active RA and incomplete response to MTX alone.1,2 In RAPID 1, co-primary end points were the clinical response rate at week 24 according to the American College of Rheumatology 20% criteria for improvement (ACR20; 59% vs 14% for placebo) and change from baseline in modified total Sharp scores (mTSS) at week 52.1 The primary end point of the RAPID 2 study was ACR20 response at week 24.2

FAST4WARD compared CIMZIA 400 mg every 4 weeks monotherapy to placebo in patients with active RA and prior failure on 1 or more synthetic disease-modifying anti-rheumatic drugs (DMARDs).4 The primary end point was ACR20 response at week 24.4

In these 3 studies, patients treated with CIMZIA experienced:

RAPID 1 and RAPID 2 design and efficacy assessments

RAPID 1 was a 52-week, double-blind, randomized, placebo-controlled study that evaluated 2 doses of lyophilized CIMZIA administered every other week in combination with weekly MTX. Patients randomized to CIMZIA received CIMZIA 400 mg at weeks 0, 2, and 4 followed by CIMZIA 200 mg (n=393) or CIMZIA 400 (n=390) every 2 weeks plus weekly MTX.1 Patients randomized to placebo (n=199) received placebo every 2 weeks plus weekly MTX.1

In RAPID 1, the co-primary end points were the ACR20 response rate at week 24 and the mean change from baseline in mTSS at week 52, a composite measure of structural joint damage.1 Secondary end points included ACR50/70 response rates at weeks 24 and 52 and mean change from baseline in the following efficacy criteria1,5:

  • mTSS at week 24
  • Health Assessment Questionnaire Disability Index (HAQ-DI) at weeks 24 and 52
  • Swollen and tender joint counts
  • Arthritis pain (measured by Visual Analog Scale [VAS])

One objective of RAPID 1 was to assess the impact of CIMZIA on self-reported health outcome measures in patients with active RA. Thus, additional secondary efficacy end points included5:

  • Health-related quality of life (HRQoL; measured by SF-36 Physical and Mental Component Summaries [PCS and MCS] and domains)
  • Fatigue (measured by the Fatigue Assessment Scale [FAS] and SF-36 Vitality domain)
  • Productivity (measured by the RA-specific Work Productivity Survey)

RAPID 2 employed a similar study design and similar efficacy assessments as RAPID 1 but was a 24-week confirmatory study evaluating the liquid formulation of CIMZIA.2 Patients were randomized to CIMZIA 400 mg at weeks 0, 2, and 4 followed by CIMZIA 200 mg (n=246) or CIMZIA 400 (n=246) or to placebo every 2 weeks plus weekly MTX.2 The primary end point was ACR20 response rate at week 24.2 Secondary end points included ACR50/70 response and mean change from baseline in mTSS, ACR core set variables, physical function and HRQoL (SF-36 PCS and MCS), and disability (HAQ-DI) at week 24.2

FAST4WARD design and efficacy assessments

FAST4WARD was a 24-week, double-blind, randomized, placebo-controlled study that evaluated monotherapy with lyophilized CIMZIA 400 mg every 4 weeks (n=111) versus placebo (n = 109).4 The primary end point was the ACR20 response rate at week 24.4 Secondary end points included ACR50/70 response rates, ACR component scores, and patient-reported outcomes (pain [VAS], fatigue [FAS], disability [HAQ-DI], and physical function and HRQoL [SF-36 PCS and MCS]).4

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