CIMZIA Rx

Rheumatoid Arthritis - Studies RA-I, RA-II, RA-III, and RA-IV

• The efficacy and safety of Cimzia was based on data from 4 randomized, placebo-controlled, double-blind studies (RA-I, RA-II, RA-III, and RA-IV) in patients 18 years of age and older with moderately to severely active rheumatoid arthritis. 

• Studies RA-I (N=592) and RA-II (N=619) included patients who had received methotrexate (MTX) for at least 6 months prior to Cimzia. Patients were randomly assigned to receive a loading dose of Cimzia 400mg at Weeks 0, 2, and 4 (both treatment arms) or placebo, followed by either 200mg or 400mg of Cimzia or placebo every other week, in combination with MTX for 52 weeks in Study RA-I and for 24 weeks in Study RA-II.

• Study RA-III included 247 patients who had active disease despite receiving MTX for at least 6 months prior to study enrollment. Patients received Cimzia 400mg every 4 weeks for 24 weeks without a prior loading dose.

• Study RA-IV included 220 patients who had failed at least 1 DMARD use prior to receiving Cimzia. Patients received Cimzia 400mg or placebo every 4 weeks for 24 weeks.

• Results from Study RA-I showed that patients in the Cimzia 200mg + MTX every 2 weeks or Cimzia 200mg + MTX then placebo + MTX treatment arms achieved higher American College of Rheumatology (ACR) response rates vs the placebo + MTX arm, respectively:

• ACR20

• Week 24: 59% vs 45% vs 14%

• Week 52: 53% vs 40% vs 13%

• ACR50

• Week 24: 37% vs 30% vs 8%

• Week 52: 38% vs 30% vs 8%

• ACR70

• Week 24: 21% vs 18% vs 3%

• Week 52: 21% vs 18% vs 4%

• Major Clinical Response: 13% vs 12% vs 1%

• In Study RA-IV, patients in the Cimzia 400mg every 4 weeks or Cimzia 400mg + placebo arms achieved higher ACR response rates vs the placebo arm, respectively:

• ACR20

• Week 24: 46% vs 36% vs 9%

• ACR50

• Week 24: 23% vs 19% vs 4%

• ACR70

• Week 24: 6% vs 6% vs 0%

• The results in Study RA-II were similar to the results in RA-I at Week 24. The results in Study RA-III were similar to those seen in Study RA-IV.

• In all 4 studies, patients who received Cimzia achieved greater improvements at Week 24 (RA-II, RA-III, and RA-IV) and at Week 52 (RA-I) from baseline in physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) compared with those who received placebo.

Psoriatic Arthritis

• The efficacy and safety of Cimzia was assessed in the PsA001 trial which included 409 patients 18 years of age and older with active psoriatic arthritis despite DMARD therapy. 

• Patients were randomly assigned to receive either a loading dose of Cimzia 400mg at Weeks 0, 2, and 4 (for both treatment arms) or placebo, followed by either Cimzia 200mg every other week or Cimzia 400mg every 4 weeks or placebo every other week.

• Results showed that patients treated with either Cimzia 200mg every 2 weeks or Cimzia 400mg every 4 weeks achieved higher ACR response rates vs those treated with placebo, respectively:

• ACR20

• Week 12: 58% vs 52% vs 24%

• Week 24: 64% vs 56% vs 24%

• ACR50

• Week 12: 36% vs 33% vs 11%

• Week 24: 44% vs 40% vs 13%

• ACR70

• Week 12: 25% vs 13% vs 3%

• Week 24: 28% vs 24% vs 4%

• Patients who received either Cimzia 200mg every 2 weeks or Cimzia 400mg every 4 weeks achieved a reduction in enthesitis of 1.8 and 1.7, respectively, at week 12 compared with a reduction of 0.9 in patients who received placebo.

• Patients who received either Cimzia 200mg every other week achieved greater reduction in radiographic progression compared with those who received placebo at week 24.

• Cimzia-treated patients achieved improvement in physical function as assessed by the HAQ-DI at week 24 compared with placebo.

Ankylosing Spondylitis

• The efficacy and safety of Cimzia was assessed in the AS-1 trial which included 325 patients 18 years of age and older with adult-onset active axial spondyloarthritis for at least 3 months and were intolerant to or had an inadequate response to at least 1 NSAID. Active disease was defined by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥4, and spinal pain ≥4 on a 0 to 10 Numerical Rating Scale (NRS).

• Patients were randomly assigned to receive either a loading dose of Cimzia 400mg at Weeks 0, 2, and 4 (for both treatment arms) or placebo, followed by either Cimzia 200mg every 2 weeks or 400mg every 4 weeks or placebo. Concomitant NSAIDs were received by 91% of the AS patients.

• Results showed that patients treated with either Cimzia 200mg every 2 weeks or 400mg every 4 weeks achieved higher ASAS response rates vs those treated with placebo, respectively:

• ASAS20

• Week 12: 57% vs 64% vs 37%

• Week 24: 68% vs 70% vs 33%

• ASAS40

• Week 12: 40% vs 50% vs 19%

• Week 24: 48% vs 59% vs 16%

Non-radiographic Axial Spondyloarthritis 

• The efficacy and safety of Cimzia was assessed in the nr-axSpA-1 trial which included 317 patients 18 years of age and older with adult-onset active axial spondyloarthritis for at least 12 months and were intolerant to or had an inadequate response to at least 2 NSAIDs. Active disease was defined by the BASDAI ≥4, and spinal pain ≥4 on a 0 to 10 Numerical Rating Scale (NRS).

• Patients were randomly assigned to receive either a loading dose of Cimzia 400mg at Weeks 0, 2, and 4 or placebo, followed by either Cimzia 200mg every 2 weeks or placebo. Patients were permitted to use concomitant medications (eg, NSAIDs, DMARDs, corticosteroids, opioids) at any time.

• Results showed that a greater proportion of patients treated with Cimzia achieved Ankylosing Spondylitis Disease Activity Score-Major Improvement (ASDAS-MI) responses vs those treated with placebo, respectively:

• ASDAS-MI

• Week 52: 47% vs 7% (odds ratio, 15.2 [95% CI, 7.3-31.6])

• ASAS-40

• Week 12: 48% vs 11% (odds ratio, 7.4 [95% CI, 4.1-13.4])

• Week 52: 57% vs 16% (odds ratio, 7.4 [95% CI, 4.3-12.6])

• In the nr-asSpA-1 study, Cimzia-treated patients achieved significantly grater improvement in the Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) score at week 12 compared with placebo-treated patients.

Crohn Disease - Study CD1

• The double-bind, randomized, placebo-controlled study included 662 patients 18 years of age and older with moderately to severely active Crohn disease. Patients were randomly assigned to receive either Cimzia or placebo at Weeks 0, 2, and 4, then every 4 weeks until Week 24.

• Clinical response was defined as at least a 100-point reduction in Crohn Disease Activity Index (CDAI) score compared to baseline, and clinical remission was defined as an absolute CDAI score of 150 points or lower.

• Results showed that a significantly greater proportion of Cimzia-treated patients achieved clinical response and clinical remission compared with placebo, respectively:

• Week 6 – Clinical Response: 35% (95% CI, 30-40) vs 27% (95% CI, 22-32) (P <.05)

• Week 6 – Clinical Remission: 22% (95% CI, 17-26) vs 17% (95% CI, 13-22)

• Week 26 – Clinical Response: 37% (95% CI, 32-42) vs 27% (95% CI, 22-31) (P <.05)

• Week 26 – Clinical Remission: 29% (95% CI, 25-34) vs 18% (95% CI, 14-22) (P <.05)

• Both Weeks 6 & 26 – Clinical Response: 23% (95% CI, 18-28) vs 16% (95% CI, 12-20) (P <.05)

Crohn Disease - Study CD2

• The randomized treatment-withdrawal study included patients 18 years of age and older with moderately to severely active Crohn disease. All patients received an initial dose of Cimzia 400mg at Weeks 0, 2, and 4 then assessed for clinical response at Week 6. Clinical response was defined as at least a 100-point reduction in CDAI score, and clinical remission was defined as CDAI less than or equal to 150 points.

• At Week 6, there were 428 clinical responders who were randomly assigned to receive either Cimzia 400mg or placebo every 4 weeks starting at Week 8 through Week 24.

• Results showed that 63% of Cimzia-treated patients achieved clinical response at Week 26 compared with 36% of placebo-treated patients (P <.05). Moreover, 48% of Cimzia-treated patients achieved clinical remission at Week 26 compared with 29% of placebo-treated patients (P <.05).

Plaque Psoriasis

• The efficacy and safety of Cimzia was assessed in 3 studies (Study PS-1, PS-2, and PS-3) which included patients 18 years of age and older with moderate to severe plaque psoriasis who were eligible for systemic therapy or phototherapy.

• In Studies PS-1 (N=234) and PS-2 (N=227), patients were randomly assigned to receive either Cimzia 200mg every other week (following a loading dose of Cimzia 400mg at Weeks 0, 2, and 4), or Cimzia 400mg every other week, or placebo. The coprimary endpoints was the proportion of patients who achieved a PASI 75 and PGA of “clear” or “almost clear” with at least a 2-point improvement at week 16.

• In Study PS-3 (N=559), patients were randomly assigned to receive either Cimzia 200mg every other week (following a loading dose of Cimzia 400mg at Weeks 0, 2, and 4), or Cimzia 400mg every other week up to Week 16, or a biologic comparator (up to Week 12). The primary endpoint was the proportion of patients who achieved PASI 75 at week 12.

• Findings from Study PS-1 showed that patients treated with Cimzia 200mg or 400mg achieved the following efficacy results at week 16 compared with those treated with placebo, respectively:

• PGA of 0 or 1: 45% vs 55% vs 4%

• PASI 75: 65% vs 75% vs 7%

• PASI 90: 36% vs 44% vs 0%

• In Study PS-2, patients treated with Cimzia 200mg or 400mg achieved the following efficacy results at week 16 compared with those treated with placebo, respectively:

• PGA of 0 or 1: 61% vs 65% vs 3%

• PASI 75: 81% vs 82% vs 13%

• PASI 90: 50% vs 52% vs 5%

• In Study PS-3, patients treated with Cimzia 200mg or 400mg achieved the following efficacy results at week 16 compared with those treated with placebo, respectively:

• PGA of 0 or 1: 52% vs 62% vs 4%

• PASI 75: 69% vs 75% vs 4%

• PASI 90: 40% vs 49% vs 0%

• Maintenance of Response

• In PS-1 and PS-2, among subjects who were PASI 75 responders at Week 16 and received Cimzia 400 mg every other week, the PASI 75 response rates at Week 48 were 94% and 81%, respectively. In subjects who were PASI 75 responders at Week 16 and received Cimzia 200 mg every other week, the PASI 75 response rates at Week 48 were 81% and 74%, respectively. 

• In PS-1 and PS-2, among subjects who were PGA clear or almost clear responders at Week 16 and received Cimzia 400 mg every other week, the PGA response rates at Week 48 were 79% and 73%, respectively. In subjects who were PGA clear or almost clear responders at Week 16 and received Cimzia 200 mg every other week, the PGA response rates at Week 48 were 79% and 76%, respectively. 

• In PS-3, subjects who achieved a PASI 75 response at Week 16 were re-randomized to either continue treatment with Cimzia or be withdrawn from therapy (i.e., receive placebo). At Week 48, 98% of subjects who continued on Cimzia 400 mg every other week were PASI 75 responders as compared to 36% of subjects who were re-randomized to placebo. Among PASI 75 responders at Week 16 who received Cimzia 200 mg every other week and were re-randomized to either Cimzia 200 mg every other week or placebo, there was also a higher percentage of PASI 75 responders at Week 48 in the Cimzia group as compared to placebo (80% and 46%, respectively).