Treatment of Rheumatoid Arthritis with Certolizumab Pegol: Results from PROACTIVE, a Non-Interventional Study in the UK and Ireland

Abstract

IntroductionThe objective of this non-interventional study was to investigate the long-term safety and effectiveness of certolizumab pegol (CZP) in patients with rheumatoid arthritis (RA) in the UK and Ireland.MethodsPatients were prescribed CZP at their physicians’ discretion and followed during routine clinical practice for up to 88 weeks. DAS28(ESR) response (defined as at least a 1.2-point reduction from baseline) was measured in the full analysis set (FAS) at week 12, and patients were categorized by week 12 responder status in all subsequent analyses. The primary outcome was DAS28(ESR) response at week 78. Secondary outcomes included change from baseline in DAS28(ESR), HAQ-DI, and RADAI scores at week 78, and EULAR response at week 78. Adverse drug reactions (ADRs) were recorded for all patients who received at least one dose of CZP.ResultsA total of 149 patients were enrolled, of whom 111 (74.5%) formed the FAS. At week 12, 80 patients (72.1%) were DAS28(ESR) responders and 31 (27.9%) non-responders. Compared to non-responders, a greater proportion of week 12 responders had a DAS28(ESR) response at week 78 (43.8% versus 22.6%). Improvements in DAS28(ESR), HAQ-DI, and RADAI scores were also greater on average among week 12 responders, as was the proportion of patients meeting EULAR criteria. Overall, 9 patients (6.1%) experienced 13 ADRs during the study.ConclusionThese data demonstrate the safety and effectiveness of CZP in adult patients with RA treated during routine clinical practice in the UK and Ireland.Trial RegistrationClinicalTrials.gov identifier, NCT01288287.FundingUCB Pharma.Electronic supplementary materialThe online version of this article (10.1007/s12325-018-0758-1) contains supplementary material, which is available to authorized users.

Effectiveness and safety of certolizumab pegol in rheumatoid arthritis patients in Canadian practice: 2-year results from the observational FαsT-CAN study

“…17 While, the PROACTIVE non-interventional study in the United Kingdom and Ireland had a higher retention rate, with 68.5% of patients completing the study to Week 88. 18 Within the present study, it was observed that similar proportions of patients achieved DAS28 < 2.6 at Week 104, whether they had <2 years or ⩾2 years RA duration. Greater improvements in disease activity (DAS28) were observed in anti-TNF-naïve patients, when compared to patients with prior anti-TNF experience.…”

Three-year clinical outcomes in patients with rheumatoid arthritis treated with certolizumab pegol: results from the observational ECLAIR study

“…The majority of patients achieved a EULAR response within 12 months (75.3%), which was sustained to 36 months among patients still in the study. Similar improvements in disease activity have been observed in previous observational studies into the long-term effec-tiveness of CZP (11)(12)(13). However, the EULAR response rate in ECLAIR was lower compared to the RAPID 1 study (96.2% at 12 months), which is likely due to higher baseline disease activity in the latter.…”

“…Long-term observational data in more representative populations are therefore necessary, and are frequently considered or requested by health authorities. Several observational studies have previously reported on the effectiveness and safety of CZP in real-world settings in Canada, Germany and the UK, but an observational study of an anti-TNF has yet to be conducted in France (11)(12)(13). To this end, the French National Authority for Health requested an observational study to assess the effectiveness and safety of CZP up to 36 months in patients with moderate-to-severe RA in a real-world setting in France.…”

Piggybacked by PEGylation?

“…In contrast, a study by Keystone et al [ 5 ] predicted the 52-week response of CZP after three injections. Due to the different dosing schedules, concomitant medications, and other confounding factors, prediction of the time point of the long-term treatment response to different bDMARDs is expected to vary [ 6 ]. Studies have also found that CZP provided rapid and sustained clinical improvement in RA patients regardless of prior TNFi use [ 7 ].…”