RAPID-axSpA study design2,3:
The RAPID-axSpA trial (nr-axSpA and AS patients) was a 204-week, Phase 3, multicenter, randomized, double-blind, placebo-controlled study of 325 patients aged ≥18 years who had either nr-axSpA (n=147) or AS (n=178). Patients were randomized to CIMZIA 200 mg Q2W (n=111), CIMZIA 400 mg Q4W (n=107), or placebo (n=107). CIMZIA-treated patients were given a loading dose of 400 mg of CIMZIA at Weeks 0, 2, and 4. The 24-week, double-blind, placebo-controlled period was followed by a dose-blind phase. CIMZIA-treated patients continued to receive their original dose regimen after Week 24 (200 mg Q2W [n=105] or 400 mg Q4W [n=98]). Placebo-treated patients who did not achieve an ASAS20 response at Weeks 14 and 16 were re-randomized to CIMZIA 200 mg Q2W (n=27) or CIMZIA 400 mg Q4W (n=29), and those who completed therapy to Week 24 were re-randomized to CIMZIA 200 mg Q2W (n=20) or CIMZIA 400 mg Q4W (n=21). An open-label period followed at Week 48 and continued to Week 204. Note: At the conclusion of the RAPID-axSpA study, CIMZIA was not yet approved for treating patients with nr-axSpA.
Sustained improvement in signs and symptoms of AS over 4 years
ASAS20/40 response rates in an AS subpopulation through Year 41,2,4*†


Some experienced ASAS20 responses as early as 1 to 2 weeks after starting CIMZIA1,2
- Placebo rates at Week 242
- ASAS20: 33%
- ASAS40: 16%
- ASAS criteria measure improvements in pain, function, morning stiffness, and patients’ overall assessment of disease activity
- Limitations of OLE data include potential bias due to open-label treatment and lack of long-term placebo control beyond Week 24‖
*The same patients may not have responded at each time point.
†RS-NRI: randomized set non-responder imputation.
‡ASAS20 at Week 12 in the AS subpopulation was a pre-specified analysis of the primary efficacy endpoint. Nominal P value.
§ASAS20 and ASAS40 at Week 204 were pre-specified secondary endpoints.
‖Line graph to Week 204 represents patients who were randomized initially to CIMZIA 200 mg Q2W.
AS: ankylosing spondylitis; ASAS: Assessment of SpondyloArthritis international Society; OLE: open-label extension; Q2W: every 2 weeks.
RAPID-axSpA study design2,3:
The RAPID-axSpA trial (nr-axSpA and AS patients) was a 204-week, Phase 3, multicenter, randomized, double-blind, placebo-controlled study of 325 patients aged ≥18 years who had either nr-axSpA (n=147) or AS (n=178). Patients were randomized to CIMZIA 200 mg Q2W (n=111), CIMZIA 400 mg Q4W (n=107), or placebo (n=107). CIMZIA-treated patients were given a loading dose of 400 mg of CIMZIA at Weeks 0, 2, and 4. The 24-week, double-blind, placebo-controlled period was followed by a dose-blind phase. CIMZIA-treated patients continued to receive their original dose regimen after Week 24 (200 mg Q2W [n=105] or 400 mg Q4W [n=98]). Placebo-treated patients who did not achieve an ASAS20 response at Weeks 14 and 16 were re-randomized to CIMZIA 200 mg Q2W (n=27) or CIMZIA 400 mg Q4W (n=29), and those who completed therapy to Week 24 were re-randomized to CIMZIA 200 mg Q2W (n=20) or CIMZIA 400 mg Q4W (n=21). An open-label period followed at Week 48 and continued to Week 204. Note: At the conclusion of the RAPID-axSpA study, CIMZIA was not yet approved for treating patients with nr-axSpA.
CIMZIA demonstrated consistent improvements in disease activity through 4 years1,2,4
BASDAI improvement from baseline through Year 4 in AS1,2,4*†


BASDAI components of disease activity


Limitations of OLE data include potential bias due to open-label treatment and lack of long-term placebo control beyond Week 24 and potential enrichment of population with responders.
The BASDAI consists of a 0 to 10 numerical rating scale, which is used to answer questions pertaining to major symptoms of AS.5
Baseline BASDAI score was 6.52 for CIMZIA patients and 6.44 for patients treated with placebo.2,4
*RS-LOCF: randomized set last observation carried forward.
†Change from baseline in BASDAI scores in the AS subpopulation was a pre-specified endpoint. Nominal P value.
‡MCID was defined as a reduction of 1 unit on the NRS.4
CIMZIA provided AS patients with meaningful improvements in back pain
Total and nocturnal spine pain improvement from baseline through Week 244§||


- Total spine pain is a component of ASAS response criteria measured by a 10-point NRS6
- Results were similar for both total spine pain and nocturnal back pain through Week 244
- MCID was defined as a reduction of 1 unit on the NRS4
- Baseline total and nocturnal spine pain scores were 7.0 and 6.7 for CIMZIA patients and 7.3 and 7.3 for patients treated with placebo, respectively4
§FAS-LOCF: full analysis set last observation carried forward.
||Nocturnal back pain was evaluated by a 10-point numeric rating scale.
¶Change from baseline in total spine pain scores in the AS subpopulation was a prespecified endpoint. Nominal P value.
Significant clinical improvements in physical function in AS patients1,2,4
BASFI improvement through Week 241,2,4#


At 24 weeks, CIMZIA demonstrated a 2.7-fold greater percent improvement in functioning from baseline vs. placebo2
- Change from baseline in BASFI scores in the AS sub-population represents improvements in patients’ ability to perform certain activities of daily living, which was a pre-specified secondary endpoint. Nominal P value
- MCID was defined as a reduction from baseline of -1 unit on the BASFI NRS in RAPID-axSpA
#RS-LOCF: randomized set last observation carried forward.
AS: ankylosing spondylitis; ASAS: Assessment of SpondyloArthritis international Society; BASDAI: Bath Ankylosing Spondylitis Disease Activity Index; BASFI: Bath Ankylosing Spondylitis Functional Index; MCID: minimum clinically important difference; MTX: methotrexate; NRS: numeric rating scale; OLE: open-label extension; Q2W: every 2 weeks.
Safety profile through 24 weeks in the AS subpopulation of RAPID-axSpA1,4
Incidence of TEAEs through Week 241,4


*For the entire placebo group, CIMZIA data from placebo subjects are not utilized.
†Drug-related TEAEs are those with a relationship of “related,” “possibly related,” or those with missing responders.
Adverse events in ≥5% of patients (CIMZIA 200 mg) through Week 241,4


*For the entire placebo group, CIMZIA data from placebo subjects are not utilized.
AS: ankylosing spondylitis; TEAE: treatment-emergent adverse event.

CIMplicity can help provide ongoing support for your patients throughout their journey.
Take a closer look at the only
PEGylated Fc-Free anti-TNF1
See the CIMZIA mechanism of action.
Fc: fragment crystallizable; PEG: polyethylene glycol; TNF: tumor necrosis factor.