Efficacy Of Certolizumab Pegol Research Articles

P092 Induction of clinical remission with certolizumab pegol in patients with ulcerative colitis who are not responders in Mexican population

BACKGROUND: The TNF alpha inhibitor have revolutionized the treatment of inflammatory bowel disease (IBD), both in ulcerative colitis (UC) and in Crohn's disease (CD), achieving not only clinical remission even the healing of the affected mucosa. In our population, 70% of patients with IBD are diagnosed as UC and 30% CD. Currently, there are only 2 biologics approved for UC: infliximab and adalimumab. One third of patients will not respond to anti-TNF after induction and up to 50% of them will lose efficacy in the first year. Certolizumab pegol (CZP) has shown therapeutic efficacy in CD. In our country there are no studies that evaluate its use in UC. The aim of this work is to assess the efficacy of CZP in patients with UC with secondary failure to 2 anti-TNF alpha. METHODS: Study proof of concept. Six patients with UC diagnosis referred to our hospital center due to secondary failure to 2 anti-TNF alpha were studied. The severity of the disease was staged according to the Mayo score. Prior authorization of the patient for treatment with CZP, we administered it, at a dose of 400 mg subcutaneously at week 0, 2 and every 4 weeks, for 12 weeks. Clinical response was reviewed at 8 and 12 weeks after the beginning of the application of the biological and also endoscopically at 8 and 12 weeks. RESULTS: 50% corresponded to female sex with a female: male 1 to 1. The median age was: 52.50 [23–63] years. Of the 6 patients, 5 had left colitis and 1 had pancolitis. 4 patients fulfilled criteria of Mayo for severe activity and 2 with moderate activity. 4 patients with an endoscopic subscore Mayo 2 and 2 patients with endoscopic subscore Mayo 3. At the baseline measurement, 50% (3) had a normal CRP and 100% had albumin within normal parameters. At 8 weeks of follow-up, 50% of patients entered clinical remission by Mayo score. 4 patients had an endoscopic subscore May 1 or lower. At 12 weeks of biological application, the same results were observed. By laboratory it was observed at 12 weeks that 83.3% had CRP within normal parameters and 66.7% had normal albumin. No secondary events were observed during the 12 weeks of treatment. CONCLUSION(S): In this work proof of concept, CZP seems to be an option in patients with UC who have had secondary failure to other anti-TNF; however, because of the small size of the sample, a prospective and randomized study is required to confirm these findings. The present work does not have conflict of interests.

Correction to: Efficacy of certolizumab pegol with and without concomitant use of disease-modifying anti-rheumatic drugs over 4years in psoriatic arthritis patients: results from the RAPID-PsA randomized controlled trial.

The above article originally published with an error present in Discussion section and presented correctly in this article. The original article was corrected.

Efficacy of certolizumab pegol with and without concomitant use of disease-modifying anti-rheumatic drugs over 4\xa0years in psoriatic arthritis patients: results from the RAPID-PsA randomized controlled trial

To report long-term efficacy of certolizumab pegol (CZP) treatment with and without concomitant DMARDs in patients with psoriatic arthritis (PsA). RAPID-PsA (NCT01087788) was double-blind and placebo-controlled to week 24, dose-blind to week 48, and open-label to week 216. Patients had active PsA with ≥ 1 failed DMARD. At baseline, patients were randomized 1:1:1 to CZP 200 mg every 2 weeks: CZP 400 mg every 4 weeks: placebo. CZP-randomized patients continued their dose into open-label. Observed case efficacy data are reported to week 216 for week 0 CZP-randomized patients (dose combined) with and without baseline DMARD use (DMARD+/DMARD−). Dactylitis (tenderness and ≥ 10% difference in swelling between affected and opposite digits) and enthesitis were measured using Leeds Dactylitis Index (LDI) and Leeds Enthesitis Index (LEI). 273/409 randomized patients received CZP from baseline: 199/273 (72.9%) DMARD+ and 74/273 (27.1%) DMARD− patients. 141/199 (70.9%) DMARD+ and 42/74 (56.8%) DMARD− patients completed Week 216. DMARD+ (79.7%) and 83.3% of DMARD− patients achieved ACR20 response at week 216; 79.2 and 78.1% achieved 75% improvement from baseline in Psoriasis Area and Severity Index (PASI75). High proportions of DMARD+/DMARD− patients with extra-articular manifestations at baseline reported total resolution at week 216; dactylitis 91.4% of DMARD+ and 93.3% of DMARD− patients, enthesitis 74.4% of DMARD+ and 87.5% of DMARD− patients. Long-term improvements in PsA symptoms were observed with CZP monotherapy or concomitant DMARDs, across important psoriatic disease domains, including joint disease, psoriasis, nail disease, dactylitis, and enthesitis.Trial registration: NCT01087788

A pooled subanalysis of the efficacy of certolizumab pegol in patients with self-reported psoriatic arthritis in ongoing phase 3 psoriasis studies (CIMPASI-1, CIMPASI-2, and CIMPACT)

A pooled subanalysis of the efficacy of certolizumab pegol in patients with self-reported psoriatic arthritis in ongoing phase 3 psoriasis studies (CIMPASI-1, CIMPASI-2, and CIMPACT)

PGA×BSA: A Measure of Psoriasis Severity Tested in Patients with Active Psoriatic Arthritis and Treated with Certolizumab Pegol.

The product of physician's global assessment and body surface area (PGA×BSA) to assess psoriasis severity has previously been investigated in patients with psoriasis, with the aim of assessing PGA×BSA as an alternative to the time-consuming Psoriasis Area and Severity Index (PASI). Here, we investigate PGA×BSA as an alternative to PASI in patients with psoriatic arthritis (PsA). Analyses used data from the double-blind, placebo-controlled, RAPID-PsA trial (NCT01087788) that investigated the efficacy of certolizumab pegol (CZP) in patients with PsA. Outcomes assessed whether the PGA×BSA and PASI results were comparable, and whether these outcomes correlated with one another or with the Dermatology Life Quality Index (DLQI). For CZP-treated patients, both PGA×BSA and PASI demonstrated similar sensitivities to treatment between baseline and Week 24, with mean improvements of 77.4% and 69.0%, respectively. Similar improvements were also seen with placebo (PGA×BSA: 3.2%, PASI: 6.1%). Achievement of 75% response criterion in PGA×BSA and PASI was attained by similar proportions of patients with CZP (PGA×BSA75: 59.0%, PASI75: 61.4%) and placebo (PGA × BSA75: 15.1%, PASI75: 15.1%). Cross tabulations showed high concordance between achievement of response outcomes in PGA×BSA and PASI (79.6-95.2%). Spearman correlations revealed strong correlations between PGA×BSA and PASI at baseline (r = 0.78; n = 225) and percentage improvement to Week 24 (r = 0.85; n = 186). Both outcomes were only moderately correlated with DLQI (r = 0.41-0.50; n = 179-249). PGA×BSA is sensitive to changes in skin manifestations in patients with PsA treated with CZP. Further, PGA×BSA correlates strongly with PASI, and achievement of 75% improvement was similar for PGA×BSA and PASI.

Matrix metalloproteinase-3 and the 7-joint ultrasound score in the assessment of disease activity and therapeutic efficacy in patients with moderate to severe rheumatoid arthritis

BackgroundThis study aimed to investigate the reliability and validity of serum matrix metalloproteinase-3 (MMP-3) levels and articular ultrasound (US) scores in assessing disease activity and therapeutic response in rheumatoid arthritis (RA) patients.MethodsA total of 151 RA patients were enrolled, of whom 22 were treated with certolizumab pegol (Cimzia, CZP). The RA patients were divided into the following four subgroups according to their disease activity score in 28 joints (DAS28): stable, mild activity, moderate activity, and high activity. Forty-three healthy controls were simultaneously studied. The serum MMP-3 levels and 7-joint US (US7) scores of all subjects were determined. The patients who were treated with CZP were subsequently followed for 6 months.ResultsThe serum MMP-3 levels of all the RA patients were significantly higher than those of healthy controls, and those of patients with moderate and severe RA were significantly higher than those of patients with stable RA. The US7 scores of patients with severe RA were significantly higher than those of patients in other groups. Using the DAS28 as a reference standard, the corresponding cutoff value of MMP-3 was 70.5 ng/ml. After CZP treatment, the MMP-3 levels and US7 scores were significantly decreased at week 2, and the mean changes in US7 scores at weeks 12 and 24 were significantly higher in both groups with American College of Rheumatology 50% positive response (ACR50) and ACR 70% positive response (ACR70) than in the negative groups.ConclusionSerum MMP-3 and the US7 scores could both effectively reflect disease activity and therapeutic responses in patients with moderate to severe RA.Trial registrationCTR20140405 (RA0044), CTR20140405: A phase 3, Multicenter, Double-blind, Placebo Controlled, Parallel Group, Randomized, 24-Week Study to Evaluate the Safety and Efficacy of Certolizumab Pegol as Additional Medication to Methotrexate in Chinese Subjects With Active Rheumatoid Arthritis Who Have an Incomplete Response to Methotrexate, Registered on 13 June 2014.CTR20140412 (RA0078), CTR20140412: A phase 3, Multicenter, Open-label Extension Study to Assess the Safety and Efficacy of Certolizumab Pegol as Additional Medication to Methotrexate in Chinese Subjects With Active Rheumatoid Arthritis Who Participated in RA0044, Registered on 02 July 2014.

Certolizumab Pegol in the Treatment of Psoriasis and Psoriatic Arthritis: Preliminary Real-Life Data.

IntroductionWe present the results of real-life tests conducted in adults affected by psoriatic arthritis (PsA) with mild cutaneous involvement to evaluate the efficacy of certolizumab pegol (CZP), an anti-tumor necrosis factor-alpha agent approved in Europe for the treatment of rheumatoid arthritis and PsA.MethodsAssessments included an evaluation of the Psoriasis Area and Severity Index (PASI) and the Disease Activity Score computed on 44 joints (DAS-44) correlated to the erythrocyte sedimentation rate (ESR) (DAS44-ESR). A total of 41 patients (16 men, 25 women; mean age 59.8 ± 8 years) completed the study. Of these, 36 patients were affected by both PsA and psoriasis, and five patients were affected only by PsA. A total of 32 patients (group A) completed 3 months of treatment (W12), and 12 patients completed 6 months of treatment (W24) (group B).ResultsThe clinical efficacy of CZP was consistent on both the cutaneous and rheumatic components of the treatment. The mean PASI score decreased from 4.4 ± 4.7 at baseline (BL) to 2.3 ± 3.7 at W12 (group A), and from 5.1 ± 5.7 at BL to 0.8 ± 1.2 at W24 (group B). The DAS44-ESR decreased from 4.4 ± 0.6 at BL to a mean of 2.2 ± 0.9 at W12 (group A) and from 4.1 ± 0.6 at BL to a mean of 1.9 ± 0.5 at W24 (group B). No adverse events were reported.ConclusionOur results demonstrate that CZP can be used safely and effectively to treat both the cutaneous and joint components of PsA. However, long-term data are needed to confirm our preliminary observations.

Long-Term Efficacy and Safety of Certolizumab Pegol in an Unselected Crohn's Disease Population: The FACTS III Survey

Background: Long-term data of certolizumab pegol (CZP) in Crohn's disease (CD) from pivotal registry trials are limited. We therefore aimed to evaluate the long-term efficacy of CZP in clinical practice in Switzerland. Methods: In the First Approved Certolizumab Therapeutic Experience in Switzerland-III phase IV multicenter cohort, patients receiving CZP were prospectively included all over Switzerland in (non-) academic hospitals and private practice. Results: We included 104 CD patients (52 male; only 22.1% anti-tumor necrosis factor (TNF) naïve, CZP as third anti-TNF agent in 46.2%) with follow-up time between 6 weeks up to 5 years. During treatment with CZP, we observed a significant decrease of the Harvey Bradshaw Index from a median of 7 at baseline (interquartile range 4-11) to 4, 5, 4, 3, 3, and 2 at weeks 6, 26, 52, 78, 104, and 156, respectively. While anti-TNF naïve patients showed a significantly better response at the end of induction, during CZP maintenance therapy response was similar as compared to anti-TNF experienced patients as well as between patients with a short (0-5 years) vs. long duration of disease (>5 years). Conclusions: CZP is an effective long-term treatment option, including CD patients with long disease duration and prior treatment with 1 or 2 anti-TNF agents.

The efficacy of certolizumab pegol over 4 years in psoriatic arthritis patients with and without concomitant use of DMARDs

The efficacy of certolizumab pegol over 4 years in psoriatic arthritis patients with and without concomitant use of DMARDs

Long-Term Maintenance of Certolizumab Pegol Safety and Efficacy, in Combination with Methotrexate and as Monotherapy, in Rheumatoid Arthritis Patients

IntroductionThe safety and efficacy of certolizumab pegol (CZP) 400 mg every 4 weeks (Q4W) monotherapy (FAST4WARD/NCT00548834) and in combination with methotrexate (MTX) (014/NCT00544154) in active rheumatoid arthritis (RA) has been published previously. This report outlines final long-term outcomes from the open-label extension (OLE) study (015/NCT00160693), which enrolled patients from these randomized controlled trials (RCTs).MethodsPatients who withdrew from or completed the 24-week 014/FAST4WARD RCTs were enrolled and received CZP 400 mg Q4W with/without MTX. Exposure-adjusted event rates (ER) per 100 patient-years (PYs) of adverse events (AEs) and serious AEs (SAEs) were reported for all patients receiving ≥1 dose of CZP in RCTs or OLE (N = 427) between first CZP dose and up to 24 weeks after last CZP dose or study withdrawal. Efficacy assessments included clinical (ACR20/50/70 response rates, TJC, SJC) and patient-reported outcomes (HAQ-DI, PtGADA, pain, fatigue) to week 304 (5.8 years) in the CZP intent-to-treat population. SDAI and CDAI outcomes were analyzed post hoc. Outcomes for CZP monotherapy and CZP+MTX combination-therapy were compared.ResultsGlobally, ERs of AEs and SAEs were 408.1 and 25.2 per 100 PY, respectively. Eleven patients had AEs leading to death (ER 0.6). Improvements in clinical and patient-reported outcomes during the 24-week RCTs were maintained to week 304, and were similar between all subpopulations.ConclusionsThe longest exposure duration to date with CZP 400 mg Q4W treatment confirmed the safety profile observed in previous studies. Initial improvements in signs and symptoms of RA, including PROs, were maintained in both CZP monotherapy and CZP + MTX combination-therapy patients. Trial registration: ClinicalTrials.gov identifier, NCT00160693. Funding: UCB Pharma.Electronic supplementary materialThe online version of this article (doi:10.1007/s40744-017-0060-8) contains supplementary material, which is available to authorized users.

Certolizumab pegol for treating axial spondyloarthritis

ABSTRACTIntroduction: Axial spondyloarthritis (axSpA) is a chronic inflammatory disease of the spine and sacroiliac (SI) joints. The spectrum of axSpA includes ankylosing spondylitis (AS) and non-radiographic axSpA (nr-axSpA). Evidence has supported the use of TNF alpha inhibitors (TNFi) in treating these diseases, with good efficacy and tolerable safety profiles. Certolizumab pegol (CZP) is an anti-TNF alpha (TNFa) agent with data to support its use in both AS and nr-axSpA.Areas covered: The pharmacologic properties of CZP were reviewed. Data regarding the use and efficacy of CZP in axSpA were reviewed. Quality of life outcomes and safety profiles of CZP in axSpA patients were discussed as well.Expert opinion: While there are several biologics with evidence for improved outcomes in AS, there is less evidence for biologic medications that have good efficacy in nr-axSpA. CZP has good evidence of improved outcomes in terms of clinical efficacy, patient reported outcomes and imaging outcomes in both conditions, with a tolerable safety profile.

Psoriatik artritte sertolizumab pegol kullanımı

Summary Certolizumab pegol is first pegylated anti-TNF drugs. In this review, safety and efficacy of certolizumab pegol evaluated in patients with psoriatic arthritis. RAPID-PSA is 24 week, double blind, placebo controlled study which assess certolizumab 200 mg/every two weeks and 400 mg/month in patients with psoriatic arthritis. At the end of 24th week, 58.0% and 51.9% of patients achieve ACR 20% response (primary clinical endpoint) for 200 mg/every two weeks and 400 mg/month dosage, respectively. Efficacy of certolizumab start 1 to 2 weeks later. These efficacy continue at least 96 weeks. Additionaly, certolizumab pegol improve functional capacity, fatigue, quality of life, dermatology quality of life index and work productivity. Radiological progression is lower with certolizumab pegol than placebo. Advers events are comperable with other anti-TNF drugs. According to this results, certolizumab pegol is a therapeutic option for DMARD resistant psoriatic arthritis patients.

The first double-blind, randomised, parallel-group certolizumab pegol study in methotrexate-naive early rheumatoid arthritis patients with poor prognostic factors, C-OPERA, shows inhibition of radiographic progression

ObjectivesTo evaluate efficacy and safety of combination therapy using certolizumab pegol (CZP) and methotrexate (MTX) as first-line treatment for MTX-naive, early rheumatoid arthritis (RA) with poor prognostic factors, compared with...

Tu1356 Efficacy of Certolizumab Pegol in an Unselected Crohn's Disease Population: Long-Term Data of the FACTS III Survey

Background: Certolizumab pegol (CTZ) is approved for the treatment of Crohn's disease (CD) in the United States and Switzerland. In view of the limited long-term data from pivotal registry trials we aimed to evaluate the efficacy and safety of CTZ in clinical long term practice in Switzerland.Methods: In the FACTS III (First Approved Certolizumab Therapeutic Experience in Switzerland) phase IV multicenter practice-based patient cohort patients receiving CTZ were prospectively included all over Switzerland in (non-) academic hospitals and private practice. Results: A total of 104 patients (52 male) were included with first CTZ dose between 11/2007-and 08/2013 with a currently ongoing follow-up of until present between 6 weeks up to 5 years (mean 67.5 weeks, CI 6-208) and baseline-characteristics as follows: mean age: 36.6 years; mean age at diagnosis: 29.4 years (Montreal A1: 8.7%, A2: 68.3%, A3: 20.2%, unknown 2.8%); disease localization L1: 13.5%, L2: 63.5%, L3: 22.1%, unknown: 1.9%; disease behavior B1: 25%, B2: 25%, B3: 47.1%, unknown: 3.9%; smokers: 33.7%; previous surgery: 44%; anti-TNF naive: 22.1%; previously received IFX, ADA orb both: 28.8%, 1.9% and 46.2%, respectively. During treatment with CTZ we observed a significant decrease of mean HBI from 8.4 at baseline to 6.1 (p=0.017), 6.1 (p= 0.063), 5.4 (p=0.002), 5.1 (p=0.009), 4.5 (p<0.001) and 3 (p<0.001) at week 6,26,52,78,104 and 156, respectively, corresponding to significantly increased rates of clinical remission at these points in time (41.4%, 40.7%, 51.9%, 58.1%, 53.6%, 73.3%; for all p<0.01). In addition, we found a sustained HBI decrease also in week 208 and 260 with mean HBI 5.6 and 5.2, respectively (however no significant difference to baseline due to small sample size), corresponding to a remission rate of 42.9% and 50% . Looking specifically at antiTNF naive, exposed, prior non-response and prior loss of response (LOR) we did not observe any differences in mean HBI during the whole period of CTZ treatment between these four groups of patients. However, at the end of induction (week 6), anti-TNF naive patients with a mean HBI of 2.6 showed a significantly better response than anti-TNF experienced (6.8, p<0.01), those with prior LOR (7.1, p<0.01) or those with prior non-response (8.5, p<0.01) to anti-TNF. In contrast to the published data regarding Adalimumab, we did not observe significant differences in mean HBI while on treatment between patients with these different intervals of disease duration (and also at baseline). Conclusions: CTZ is an effective longterm treatment in CD, including patients with long disease duration, prior treatment with 1-2 anti-TNF agents or previous LOR and non-response. Our findings underline, that there is both a place and a need for a third TNF-inhibiting agent in CD.

SAT0351 Long-Term Safety and Efficacy of Certolizumab Pegol in Patients with Axial Spondyloarthritis, Including Ankylosing Spondylitis and Non-Radiographic Axial Spondyloarthritis: 96-Week Outcomes of the Rapid-Axspa Trial

BackgroundPrevious reports of RAPID-axSpA (NCT01087762) demonstrated efficacy and safety of certolizumab pegol (CZP) in patients (pts) with axial spondyloarthritis (axSpA) including pts with ankylosing spondylitis (AS) and pts with non-radiographic...

OP0077 Long-Term Safety and Efficacy of Certolizumab Pegol in Patients with Psoriatic Arthritis with and without Prior Anti-Tumor Necrosis Factor Exposure: 96-Week Outcomes from the Rapid-Psa Trial

BackgroundPrevious reports of RAPID-PsA (NCT01087788) demonstrated efficacy and safety of certolizumab pegol (CZP) over 48 weeks (wks) in psoriatic arthritis (PsA) patients (pts), including pts with prior anti-TNF therapy.1ObjectivesTo report...

THU0162 Multiple Approaches for Implementation of Long-Term Efficacy Interpretation of Certolizumab Pegol Data: RAPID1 and RAPID2 CASE Study

BackgroundUse of imputed data vs observed data in long-term studies, as well as patient (pt) population evaluated (those completing randomized controlled trials [RCTs] vs all pts initiating treatment), can have...

FRI0246 Magnetic Resonance Imaging-Assessment of Early Response to Certolizumab Pegol in Rheumatoid Arthritis: A Randomized, Double-Blind, Placebo-Controlled Phase Iiib Study Applying Magnetic Resonance Imaging at Weeks 0, 1, 2, 4, 8 and 16

BackgroundThe OMERACT rheumatoid arthritis (RA) magnetic resonance imaging (MRI) scoring system (RAMRIS) is a validated system for assessment of synovitis, bone edema and bone erosion. Previous studies have reported that...

Efficacy and Safety of Certolizumab Pegol in Rheumatoid Arthritis: Meeting Rheumatologists’ Requirements in Routine Clinical Practice

Certolizumab pegol, a pegylated Fab' anti-tumour necrosis factor (TNF)-α agent, has shown efficacy in patients with rheumatoid arthritis (RA) unresponsive to previous treatment. In key randomised controlled trials involving patients with moderate to severe RA and an inadequate response to methotrexate or one or more disease-modifying antirheumatic drug (DMARD), the efficacy of certolizumab pegol, as monotherapy or with methotrexate, was similar to that reported in other anti-TNF clinical studies, with 60% or fewer of patients achieving American College of Rheumatology 20% improvement in RA. Rapid clinical response was also seen, with significant differences evident at week 1, and efficacy maintained at study end and in open-label extensions. Adding certolizumab pegol to non-biological DMARDs is efficacious in other RA populations. In the CERTAIN study, certolizumab increased remission rates, prevented disease worsening and improved work productivity and daily activity in patients with low to moderate RA. In the REALISTIC study, rapid and consistent clinical responses were observed in a diverse group of anti-TNF-eligible RA patients representing those seen in clinical practice. In the RAPID studies, rapid and sustained reduction in RA signs and symptoms, inhibition of structural joint damage progression, and improved physical function were seen with certolizumab pegol plus methotrexate versus methotrexate alone in RA patients with an incomplete response to methotrexate. Certolizumab pegol was generally well-tolerated in clinical trials, although long-term observational data are not yet available. Current data suggest that certolizumab pegol suits a 'treat to target' approach, providing rapid and sustained improvements in RA signs and symptoms, and beneficial effects on workplace and home productivity in patients with RA.

103. Long-Term Safety and Efficacy of Certolizumab Pegol in Combination with Methotrexate in the Treatment of Rheumatoid Arthritis: 5-Year Results from a 52-Week Randomized Controlled Trial and Open-Label Extension Study

103. Long-Term Safety and Efficacy of Certolizumab Pegol in Combination with Methotrexate in the Treatment of Rheumatoid Arthritis: 5-Year Results from a 52-Week Randomized Controlled Trial and Open-Label Extension Study