RAPID-PsA study design2:
RAPID-PsA was a randomized, multicenter, Phase 3 trial in patients with active PsA. The trial was double-blind and placebo-controlled through Week 24, followed by an extension study that was dose-blind through Week 48 and open-label through Week 216. In this study, 409 patients who had failed ≥1 DMARDs (nonbiologic or biologic) were randomized (1:1:1) to CIMZIA 200 mg Q2W (n=138), CIMZIA 400 mg Q4W (n=135) or placebo (n=136). Patients were stratified by prior TNFi exposure; primary non-responders were excluded.
CIMZIA delivered sustained joint improvements over 4 years
ACR20/50/70 response rates in CIMZIA 200 mg Q2W patients (n=138)1-3*†‡


Some CIMZIA patients achieved an ACR20 response as early as 1 to 2 weeks1,2
- Placebo (n=136) rates at Week 24—ACR20: 24%; ACR50: 13%; ACR70: 4%1,2
- ACR response criteria assess changes in swollen and tender joints, pain, functional ability, patient and physician global assessment, and acute phase reactant
- Limitation of OLE data: Potential bias due to open-label treatment and no long-term placebo comparator for ACR responder rates beyond Week 24
- Line graph to Week 216 represents patients who were randomized initially to CIMZIA 200 mg Q2W
*The same patients may not have responded at each time point.1-3
†Randomized set. Non-responder imputation.
‡P<0.001 vs. placebo.1-3
CIMZIA inhibited progression of structural damage
Mean change in mTSS at Week 241,2§||


Of those receiving CIMZIA 200 mg Q2W (n=98),
8 out of 10 x-rayed patients experienced no radiographic progression over 4 years3¶
X-rayed patients receiving CIMZIA 200 mg Q2W were analyzed using observed case analysis.
Radiographic data do not have long-term placebo comparison beyond 24 weeks
Patients treated with CIMZIA 400 mg Q4W did not demonstrate greater inhibition of radiographic progression compared with placebo-treated patients at Week 24.
- Limitations of OLE data include potential bias due to open-label treatment, lack of long-term placebo control beyond Week 24, and potential enrichment of population with responders
§Randomized set; for placebo patients who escaped early to CIMZIA, the Week 24 values were linearly extrapolated; ANCOVA model.3
||For placebo patients who escaped early to CIMZIA, the Week 24 values were linearly extrapolated. The P value of CIMZIA vs. placebo is based on analysis of covariance. For patients with two radiographs, but a missing Week 24 or baseline film, linear extrapolation was performed in all approaches.
¶“No progression” was defined as a change from baseline in mTSS of ≤0.5. When “no progression” was defined as a change from baseline in mTSS of ≤0, 63.3% of x-rayed patients experienced no progression.4
ACR: American College of Rheumatology; ANCOVA: analysis of covariance; DMARD: disease-modifying antirheumatic drug; mTSS: modified Total Sharp Score; OLE: open-label extension; PsA: psoriatic arthritis; Q2W: every 2 weeks; Q4W: every 4 weeks; TNFi: tumor necrosis factor inhibitor.
RAPID-PsA study design2:
RAPID-PsA was a randomized, multicenter, Phase 3 trial in patients with active PsA. The trial was double-blind and placebo-controlled through Week 24, followed by an extension study that was dose-blind through Week 48 and open-label through Week 216. In this study, 409 patients who had failed ≥1 DMARDs (nonbiologic or biologic) were randomized (1:1:1) to CIMZIA 200 mg Q2W (n=138), CIMZIA 400 mg Q4W (n=135) or placebo (n=136). Patients were stratified by prior TNFi exposure; primary non-responders were excluded.
CIMZIA delivered improvements in patients’ skin over 4 years
PASI75/90/100 response rate in a subpopulation of CIMZIA 200 mg Q2W patients with PsA (n=90)1,2*†


- Placebo rates at Week 24—PASI90: 6%; PASI100: 2%2
- Baseline psoriatic skin involvement ≥3% of body surface area (62% overall) and median PASI at baseline was 7.1 for placebo and 7.0 for CIMZIA2
- Limitations of OLE data include potential bias due to open-label treatment and lack of long-term placebo control beyond Week 24
*RS-NRI: randomized set non-responder imputation.
†PASI75 response rate at Week 24 in patients with baseline psoriatic skin involvement ≥3% body surface area was a prespecified secondary end point for the combined dose CIMZIA group.
‡Nominal P value.
DMARD: disease-modifying antirheumatic drug; OLE: open-label extension; PASI: Psoriasis Area and Severity Index; PsA: psoriatic arthritis; Q2W: every 2 weeks; Q4W: every 4 weeks; TNFi: tumor necrosis factor inhibitor.
RAPID-PsA study design2:
RAPID-PsA was a randomized, multicenter, Phase 3 trial in patients with active PsA. The trial was double-blind and placebo-controlled through Week 24, followed by an extension study that was dose-blind through Week 48 and open-label through Week 216. In this study, 409 patients who had failed ≥1 DMARDs (nonbiologic or biologic) were randomized (1:1:1) to CIMZIA 200 mg Q2W (n=138), CIMZIA 400 mg Q4W (n=135) or placebo (n=136). Patients were stratified by prior TNFi exposure; primary non-responders were excluded.
Total resolution of enthesitis over 4 years (post hoc analysis of combined doses from 4-year OLE of RAPID-PsA)3,4


~7 out of every 10 patients with baseline involvement went on to achieve total resolution of enthesitis over 4 years3,4
Post hoc analysis: Total resolution of enthesitis defined as the percent of patients with baseline involvement defined by LEI >0 achieving complete clearance (LEI=0).
- 63% of CIMZIA patients and 67% of placebo patients had enthesitis at baseline2
- Pre-specified secondary end point was “Change from baseline in the LEI at Weeks 12 and 24 (other timepoints were exploratory)”
- Limitations of OLE data include potential bias due to open-label treatment and lack of long-term placebo control beyond Week 24
- This subgroup analysis is a post hoc analysis. The RAPID-PsA study was not powered for this subgroup analysis, nor was the analysis error controlled. Therefore, these results should be interpreted with caution, and the data observed in this subgroup cannot be regarded as statistically significant
Total resolution of dactylitis over 4 years (RS, LOCF) (post hoc analysis from 4‑year OLE of RAPID-PsA)3,4


>8 out of every 10 patients with baseline involvement achieved total resolution of dactylitis3,4
Post hoc analysis, RS, LOCF, (n=35 patients with LDI >0 at baseline): Total resolution defined as LDI=0 in patients who at baseline had at least 1 digit affected and with a difference in circumference ≥10% compared with the opposite digit LDI >0.
- 34% of CIMZIA patients and 33% of placebo patients had dactylitis at baseline4
- Pre-specified secondary end point was “Change from baseline in LDI at Weeks 12 and 24 (other timepoints were exploratory)”
- Limitations of OLE data include potential bias due to open-label treatment and lack of long-term placebo control beyond Week 24
- This subgroup analysis is a post hoc analysis of the CZP 200 mg study arm of RAPID-PsA. The RAPID-PsA study was not powered for this subgroup analysis, nor was the analysis error controlled. Therefore, these results should be interpreted with caution, and the data observed in this subgroup cannot be regarded as statistically significant
Total resolution of nail psoriasis in the most severe nail of the hand over 4 years (LOCF) (post hoc analysis from 4-year OLE of RAPID-PsA)3,4


~6 out of every 10 patients with baseline involvement went on to achieve total resolution of nail psoriasis over 4 years3,4
Post hoc analysis: Total resolution rates for nail psoriasis in the most severe nail of the hand are presented for patients affected by this condition at baseline. This condition was defined at baseline as modified (mNAPSI) >0 for nail psoriasis.3,4
- Change from baseline in mNAPSI score in the subgroup of subjects with psoriatic nail disease at baseline was a pre-specified other efficacy variable
- Limitations of OLE include potential for enrichment of long-term data in the remaining patient population, as those who remain in the study generally fare better than those who discontinue. This subgroup analysis is a post hoc analysis. The RAPID-PsA study was not powered for this subgroup analysis, nor was the analysis error controlled. Therefore, these results should be interpreted with caution, and the data observed in this subgroup cannot be regarded as statistically significant
*92 patients of the 138 patients in the CIMZIA 200 mg Q2W arm had baseline nail disease and were evaluated through Week 216.
CZP: certolizumab pegol; DMARD: disease-modifying antirheumatic drug; LDI: Leeds Dactylitis Index; LEI: Leeds Enthesitis Index; LOCF: last observation carried forward; mNAPSI: Nail Psoriasis Severity Index; OLE: open-label extension; PsA: psoriatic arthritis; Q2W: every 2 weeks; Q4W: every 4 weeks; RS: randomized set; TNFi: tumor necrosis factor inhibitor.
RAPID-PsA study design2:
RAPID-PsA was a randomized, multicenter, Phase 3 trial in patients with active PsA. The trial was double-blind and placebo-controlled through Week 24, followed by an extension study that was dose-blind through Week 48 and open-label through Week 216. In this study, 409 patients who had failed ≥1 DMARDs (nonbiologic or biologic) were randomized (1:1:1) to CIMZIA 200 mg Q2W (n=138), CIMZIA 400 mg Q4W (n=135) or placebo (n=136). Patients were stratified by prior TNFi exposure; primary non-responders were excluded.
Improvement in signs and symptoms regardless of prior TNFi experience3,4
ACR20/50/70 response at Year 43*


- Primary efficacy variable of ACR20 response at Week 12 (P<0.001). ACR20 responses for CIMZIA 200 mg Q2W and placebo were 58% and 24%, respectively1,4
- 20% of patients had prior TNFi exposure, primary non-responders excluded1,4
- Limitations of open-label extension data include potential bias due to open-label treatment and lack of long-term placebo control beyond Week 24
*Randomized set—NRI.
†CIMZIA combined dose included patients receiving CIMZIA 200 mg Q2W and patients receiving CIMZIA 400 mg Q4W.
ACR: American College of Rheumatology; DMARD: disease-modifying antirheumatic drug; NRI: non-responder imputation; PsA: psoriatic arthritis; Q2W: every 2 weeks; Q4W: every 4 weeks; TNFi: tumor necrosis factor inhibitor.
RAPID-PsA study design2:
RAPID-PsA was a randomized, multicenter, Phase 3 trial in patients with active PsA. The trial was double-blind and placebo-controlled through Week 24, followed by an extension study that was dose-blind through Week 48 and open-label through Week 216. In this study, 409 patients who had failed ≥1 DMARDs (nonbiologic or biologic) were randomized (1:1:1) to CIMZIA 200 mg Q2W (n=138), CIMZIA 400 mg Q4W (n=135) or placebo (n=136). Patients were stratified by prior TNFi exposure; primary non-responders were excluded.
CIMZIA helped patients achieve a reduction in pain that lasts
Change from baseline in patients’ global assessment of arthritis pain through Year 43,4*†


50% reduction in pain score at Year 4 with CIMZIA 200 mg Q2W3,4
- Baseline pain score was 60 (VAS: 0=no pain and 100=most severe pain) for both the placebo arm and the CIMZIA 200 mg Q2W arm3,4†
- Limitations of OLE data include potential bias due to open label treatment and lack of long-term placebo control beyond Week 24
*Pain assessment is a part of the ACR score. Pain assessment is done by the patient, hence individual assessment/score may vary from patient to patient. Patient assessment of arthritis pain, VAS: 0=no pain and 100=most severe pain.
†Randomized set. LOCF is used for missing data, early withdrawals, or placebo escape.
Help patients get back to daily life with CIMZIA
Mean improvement from baseline in physical function—PsA HAQ-DI improvement through Week 241,2,4‡


8 meaningful measures for patients: HAQ-DI


- Change from baseline in HAQ-DI scores represents improvements in patients’ ability to perform certain activities of daily living in the RAPID-PsA study. Physical function was a prespecified end point
- MCID was defined as a reduction in HAQ-DI from baseline of ≥0.3
‡ITT-LOCF: intent-to-treat last observation carried forward.
ACR: American College of Rheumatology; DMARD: disease-modifying antirheumatic drug; HAQ-DI: Health Assessment Questionnaire Disability Index; LOCF: last observation carried forward; MCID: minimum clinically important difference; OLE: open-label extension; PsA: psoriatic arthritis; Q2W: every 2 weeks; Q4W: every 4 weeks; TNFi: tumor necrosis factor inhibitor; VAS: visual analog scale.
Safety profile through 24 weeks in RAPID-PsA1,2
Incidence of TEAEs through Week 242


*Placebo escape at Week 16; data not adjusted for exposure.2
†Myocardial infarction. Considered unrelated to study medication by investigators.2
TEAEs with an incidence of >3% of patients (CIMZIA 200 mg) through Week 241,4


- Most AEs were mild to moderate in severity
‡Not adjusted for exposure.
§Placebo escape at Week 16.2
AE: adverse event; CPK: creatine phosphokinase; PsA: psoriatic arthritis; TEAE: treatment-emergent adverse event.

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Fc: fragment crystallizable; PEG: polyethylene glycol; TNF: tumor necrosis factor.