RAPID-PsA Study Showed That Cimzia® (Certolizumab Pegol) Improved Active Psoriatic Arthritis, In Patients Both With And Without Prior TNF Exposure
ACR20 response rates with certolizumab pegol were higher than placebo at weeks 12 and 24 with response observed as early as week 1 in some patients1
Last week the British Society of Rheumatology annual meeting UCB presented results from the RAPID™-PsA study. Data presented from this phase 3 study showed that compared to placebo, certolizumab pegol provided improvements in the signs and symptoms of psoriatic arthritis (PsA) in adult patients, both with and without prior anti-TNF (tumor necrosis factor) exposure1.
The data, taken from RAPID-PsA (a 158-week, Phase III, multicentre study in PsA patients) showed that ACR20 response at Week 12 was significantly higher in the certolizumab pegol 200 mg Q2W and certolizumab pegol 400 mg Q4W arms vs PBO. Response rates were observed as early as Week 1 and maintained to Week 24. The majority of the ACR response rate was achieved by Week 12. No new safety signal was observed using certolizumab pegol in PsA as compared with safety of certolizumab pegol in RA1.
“The study has produced informative clinical data. It has enabled us to observe rapid responses that may be maintained for extended periods and can positively impact on the patient’s quality of life” said Professor Ade Adebajo, Consultant Rheumatologist at Barnsley Hospital NHS Foundation Trust. “To have an additional effective therapy option for patients suffering with psoriatic arthritis would be welcomed by those of us treating patients with this chronic disease”.
At Week 24, ACR response rates were similar between certolizumab pegol arms and greater vs placebo irrespective of prior anti-TNF exposure. Treatment with certolizumab pegol resulted in statistically significant improvements in physical function compared to placebo, measured by mean change in HAQ-DI at week 24 (combined certolizumab pegol groups: -0.50 vs. placebo: -0.19, p<0.001); the difference between certolizumab pegol and placebo treated patients was seen by week 2 (-0.23 vs. -0.13, p=0.005)1.
Additionally, for patients with baseline nail disease, the mNAPSI change from baseline at week 24 was 1.6 with certolizumab pegol 200 mg Q2W and -2.0 with certolizumab pegol 400 mg Q4W vs. -1.1 with placebo (p=0.003 and p<0.001, respectively). Lastly, in patients with ≥3% BSA psoriasis involvement at baseline, PASI75 response occurred more frequently in the certolizumab pegol groups at weeks 12 and 24 compared to placebo1.
In RAPID-PsA adverse events occurred in 62% vs. 68% and serious adverse events in 7% vs. 4% in certolizumab pegol (combined dose) vs. placebo, respectively.1 The most common adverse events with >5% incidence in both certolizumab pegol dosing arms or placebo were nasopharyngitis and upper respiratory tract infections. The most common serious adverse events in both certolizumab pegol dosing arms or placebo groups were infections and infestations (1.2% in the certolizumab pegol combined group vs. 0.7% in the placebo group).2
Certolizumab pegol is not approved in the indication of psoriatic arthritis. UCB has filed certolizumab pegol in this indication with global regulatory authorities.
Certolizumab pegol is the first PEGylated anti-TNF (Tumour Necrosis Factor alpha) to be launched for the treatment of moderate to severe active RA, in combination with methotrexate (MTX), in adult patients when the response to disease-modifying antirheumatic drugs (DMARDs) including methotrexate, has been inadequate. Certolizumab pegol has also been approved for use alone as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate, in the same patient population.
Certolizumab pegol is a monoclonal antibody with high specificity for human TNF-alpha, selectively neutralising the pathophysiological effects of TNF-alpha. Over the past decade, TNF-alpha has emerged as a major target of basic research and clinical investigation. This cytokine plays a key role in mediating inflammation, and excess TNF-alpha production has been directly implicated in a wide variety of diseases. Cimzia® is a registered trademark of UCB PHARMA S.A.
The RAPID™-PsA study is an ongoing 158 week study that was double-blind and placebo controlled to week 24, dose-blind to week 48 and open label to week 158. The study randomized 409 patients (1:1:1) with active psoriatic arthritis to receive either certolizumab pegol 200 mg every 2 weeks or 400 mg every 4 weeks or placebo. In the certolizumab pegol arms, patients received a loading dose of 400 mg certolizumab pegol at weeks 0, 2 and 4. Patients enrolled in this study must have failed at least one prior disease-modifying anti-rheumatic drug (DMARD). Patients in the study could have received one previous anti-TNF, provided they were not primary non-responders, as determined by the investigator. At baseline, approximately 19% of patients had previously failed one anti-TNF. Within the placebo arm, patients who did not respond to treatment (response defined as ≥10% decrease in tender joint count and swollen joint count) at weeks 14 and 16 were re-randomized at Week 16 to receive certolizumab pegol 200 mg every 2 weeks or 400 mg every 4 weeks following the loading dose.1
1. Mease P. J., Fleischmann R., Deodhar A. et al. Effect of certolizumab pegol on signs and symptoms in patients with psoriatic arthritis: 24 week results of a phase 3 double blind randomized placebo-controlled study (RAPID-PSA). Presented at the British Society for Rheumatology congress 2013.
2. UCB data on file
April 2013 – UK/13CI0041