scholarly journals A rheumatoid arthritis patient with delivery who started certolizumab pegol and tacrolimus during pregnancy

2021 ◽  
Author(s):  
Satoshi Ito ◽  
Hajime Ishikawa ◽  
Ryuta Kato
Keyword(s):  
Rheumatoid Arthritis ◽  
Rheumatoid Arthritis Patient ◽  
Polyethylene Glycol ◽  
Disease Activity ◽  
Joint Pain ◽  
Placental Transfer ◽  
Certolizumab Pegol ◽  
Normal Delivery

ABSTRACT We experienced a patient in her 30s with rheumatoid arthritis (RA) who achieved delivery with the use of certolizumab pegol (CZP) and tacrolimus (TAC) during pregnancy. She developed RA in X - 3 year and was treated with salazosulfapyridine (SASP). In X - 2 year, she became pregnant and discontinued SASP and had a normal delivery despite joint pain during pregnancy. She restarted SASP in X - 1 year and became pregnant again in X year. She experienced a flare-up of RA and was referred to our rheumatic centre. We introduced CZP and TAC, and she discontinued these agents and started prednisolone just before delivery. There is reportedly minimal placental transfer of CZP because of its Fc-free structure, since the Fc part of CZP is replaced by polyethylene glycol. TAC was contraindicated during pregnancy until 2018, but its usage in such patients is now approved. Despite the flare-up of RA during pregnancy, we were able to reduce the disease activity by introducing CZP and TAC during pregnancy. We believe that the present findings support the efficacy of this approach for treating RA flare during pregnancy.

scholarly journals Plasma interferon-alpha is associated with double-positivity for autoantibodies but is not a predictor of remission in early rheumatoid arthritis—a spin-off study of the NORD-STAR randomized clinical trial

2021 ◽  
Vol 23 (1) ◽  
Author(s):  
Marit Stockfelt ◽  
Anna-Carin Lundell ◽  
Merete Lund Hetland ◽  
Mikkel Østergaard ◽  
Till Uhlig ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trial ◽  
Disease Activity ◽  
Randomized Clinical Trial ◽  
Early Rheumatoid Arthritis ◽  
Treatment Initiation ◽  
Certolizumab Pegol ◽  
Type I ◽  
Protein Levels ◽  
Early Ra

Abstract Background The type I interferon (IFN) gene signature is present in a subgroup of patients with early rheumatoid arthritis (RA). Protein levels of IFNα have not been measured in RA and it is unknown whether they associate with clinical characteristics or treatment effect. Methods Patients with early untreated RA (n = 347) were randomized to methotrexate combined with prednisone, certolizumab-pegol, abatacept, or tocilizumab. Plasma IFNα protein levels were determined by single molecular array (Simoa) before and 24 weeks after treatment initiation and were related to demographic and clinical factors including clinical disease activity index, disease activity score in 28 joints, swollen and tender joint counts, and patient global assessment. Results IFNα protein positivity was found in 26% of the patients, and of these, 92% were double-positive for rheumatoid factor (RF) and anti-citrullinated protein antibodies (ACPA). IFNα protein levels were reduced 24 weeks after treatment initiation, and the absolute change was similar irrespective of treatment. IFNα protein positivity was associated neither with disease activity nor with achievement of CDAI remission 24 weeks after randomization. Conclusion IFNα protein positivity is present in a subgroup of patients with early RA and associates with double-positivity for autoantibodies but not with disease activity. Pre-treatment IFNα positivity did not predict remission in any of the treatment arms, suggesting that the IFNα system is distinct from the pathways of TNF, IL-6, and T-cell activation in early RA. A spin-off study of the NORD-STAR randomized clinical trial, NCT01491815 (ClinicalTrials), registered 12/08/2011, https://clinicaltrials.gov/ct2/show/NCT01491815.

Disease activity assessment in rheumatoid arthritis

2020 ◽  
pp. 161-168
Author(s):  
Josef Smolen
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Joint Pain ◽  
Joint Stiffness ◽  
Treat To Target ◽  
Therapeutic Decision ◽  
Activity Assessment ◽  
Disease Modifying ◽  
Therapeutic Decision Making ◽  
Disease Activity Assessment

The major clinical hallmarks of rheumatoid arthritis (RA) are articular swelling, joint pain, and morning joint stiffness. Disease activity assessment is pivotal when following patients with RA throughout the course of their disease, and especially when assessing improvement or deterioration upon institution of the necessary therapies. To prevent an adverse outcome, it is essential to diagnose the disease early and to start treatment with disease-modifying antirheumatic drugs (DMARDs) immediately after diagnosis. Adhering to the treat-to-target approach, which is a central strategy irrespective of the type of treatment available and the therapy applied, requires consistency in using validated composite measures of disease activity. Rather than a mere matter of using specific therapies, it is also a matter of using tools for disease activity assessment to guide therapeutic decision-making. This enables offering and achieving the best possible outcomes for RA patients.

scholarly journals Efficacy and safety of bimekizumab as add-on therapy for rheumatoid arthritis in patients with inadequate response to certolizumab pegol: a proof-of-concept study

2019 ◽  
Vol 78 (8) ◽  
pp. 1033-1040 ◽  
Author(s):  
Sophie Glatt ◽  
Peter C Taylor ◽  
Iain B McInnes ◽  
Georg Schett ◽  
Robert Landewé ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Certolizumab Pegol ◽  
Inadequate Response ◽  
Proof Of Concept ◽  
Efficacy And Safety ◽  
Open Label ◽  
Double Blind ◽  
Reactive Protein ◽  
Dual Inhibition

ObjectiveEvaluate the efficacy and safety of dual neutralisation of interleukin (IL)-17A and IL-17F with bimekizumab, a monoclonal IgG1 antibody, in addition to certolizumab pegol (CZP) in patients with rheumatoid arthritis (RA) and inadequate response (IR) to certolizumab pegol.MethodsDuring this phase 2a, double-blind, proof-of-concept (PoC) study (NCT02430909), patients with moderate-to-severe RA received open-label CZP 400 mg at Weeks 0, 2 and 4, and 200 mg at Week 6. Patients with IR at Week 8 (Disease Activity Score 28-joint count C-reactive protein (DAS28(CRP))>3.2) were randomised 2:1 to CZP (200 mg every 2 weeks (Q2W)) plus bimekizumab (240 mg loading dose then 120 mg Q2W) or CZP plus placebo. The primary efficacy and safety variables were change in DAS28(CRP) between Weeks 8 and 20 and incidence of treatment-emergent adverse events (TEAEs).ResultsOf 159 patients enrolled, 79 had IR at Week 8 and were randomised to CZP plus bimekizumab (n=52) or CZP plus placebo (n=27). At Week 20, there was a greater reduction in DAS28(CRP) in the CZP-IR plus bimekizumab group compared with the CZP-IR plus placebo group (99.4% posterior probability). The most frequent TEAEs were infections and infestations (CZP plus bimekizumab, 50.0% (26/52); CZP plus placebo, 22.2% (6/27)).ConclusionsPoC was confirmed based on the rapid decrease in disease activity achieved with 12 weeks of CZP plus bimekizumab. No unexpected or new safety signals were identified when neutralising IL-17A and IL-17F in patients with RA concomitantly treated with CZP, but the rate of TEAEs was higher with dual inhibition.

scholarly journals Active conventional treatment and three different biological treatments in early rheumatoid arthritis: phase IV investigator initiated, randomised, observer blinded clinical trial

BMJ ◽  
2020 ◽  
pp. m4328
Author(s):  
Merete Lund Hetland ◽  
Espen A Haavardsholm ◽  
Anna Rudin ◽  
Dan Nordström ◽  
Michael Nurmohamed ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Early Rheumatoid Arthritis ◽  
Conventional Treatment ◽  
Certolizumab Pegol ◽  
Biological Treatments ◽  
Remission Rates ◽  
Treatment Naïve ◽  
Secondary Outcomes ◽  
Citrullinated Protein

Abstract Objective To evaluate and compare benefits and harms of three biological treatments with different modes of action versus active conventional treatment in patients with early rheumatoid arthritis. Design Investigator initiated, randomised, open label, blinded assessor, multiarm, phase IV study. Setting Twenty nine rheumatology departments in Sweden, Denmark, Norway, Finland, the Netherlands, and Iceland between 2012 and 2018. Participants Patients aged 18 years and older with treatment naive rheumatoid arthritis, symptom duration less than 24 months, moderate to severe disease activity, and rheumatoid factor or anti-citrullinated protein antibody positivity, or increased C reactive protein. Interventions Randomised 1:1:1:1, stratified by country, sex, and anti-citrullinated protein antibody status. All participants started methotrexate combined with (a) active conventional treatment (either prednisolone tapered to 5 mg/day, or sulfasalazine combined with hydroxychloroquine and intra-articular corticosteroids), (b) certolizumab pegol, (c) abatacept, or (d) tocilizumab. Main outcome measures The primary outcome was adjusted clinical disease activity index remission (CDAI≤2.8) at 24 weeks with active conventional treatment as the reference. Key secondary outcomes and analyses included CDAI remission at 12 weeks and over time, other remission criteria, a non-inferiority analysis, and harms. Results 812 patients underwent randomisation. The mean age was 54.3 years (standard deviation 14.7) and 68.8% were women. Baseline disease activity score of 28 joints was 5.0 (standard deviation 1.1). Adjusted 24 week CDAI remission rates were 42.7% (95% confidence interval 36.1% to 49.3%) for active conventional treatment, 46.5% (39.9% to 53.1%) for certolizumab pegol, 52.0% (45.5% to 58.6%) for abatacept, and 42.1% (35.3% to 48.8%) for tocilizumab. Corresponding absolute differences were 3.9% (95% confidence interval −5.5% to 13.2%) for certolizumab pegol, 9.4% (0.1% to 18.7%) for abatacept, and −0.6% (−10.1% to 8.9%) for tocilizumab. Key secondary outcomes showed no major differences among the four treatments. Differences in CDAI remission rates for active conventional treatment versus certolizumab pegol and tocilizumab, but not abatacept, remained within the prespecified non-inferiority margin of 15% (per protocol population). The total number of serious adverse events was 13 (percentage of patients who experienced at least one event 5.6%) for active conventional treatment, 20 (8.4%) for certolizumab pegol, 10 (4.9%) for abatacept, and 10 (4.9%) for tocilizumab. Eleven patients treated with abatacept stopped treatment early compared with 20-23 patients in the other arms. Conclusions All four treatments achieved high remission rates. Higher CDAI remission rate was observed for abatacept versus active conventional treatment, but not for certolizumab pegol or tocilizumab versus active conventional treatment. Other remission rates were similar across treatments. Non-inferiority analysis indicated that active conventional treatment was non-inferior to certolizumab pegol and tocilizumab, but not to abatacept. The results highlight the efficacy and safety of active conventional treatment based on methotrexate combined with corticosteroids, with nominally better results for abatacept, in treatment naive early rheumatoid arthritis. Trial registration EudraCT2011-004720-35, NCT01491815 .

scholarly journals Case Report: Reactive Perforating Collagenosis in Rheumatoid Arthritis Patient After Use of Certolizumab Pegol

2021 ◽  
Author(s):  
ELIZANDRA TOMAZELA LAURENTI POLITO ◽  
BRUNA SCARDINI SALAROLI ◽  
LUIZ FELLIPE FAVORETO GENELHU ◽  
THAYS ZANON CASAGRANDE ◽  
ANA PAULA ESPINDULA GIANORDOLI ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Case Report ◽  
Rheumatoid Arthritis Patient ◽  
Certolizumab Pegol ◽  
Reactive Perforating Collagenosis

scholarly journals Exposure–Response Relationship of Certolizumab Pegol and Achievement of Low Disease Activity and Remission in Patients With Rheumatoid Arthritis

2020 ◽  
Vol 13 (4) ◽  
pp. 743-751
Author(s):  
Stéphane Paul ◽  
Hubert Marotte ◽  
Arthur Kavanaugh ◽  
Philippe Goupille ◽  
Tore K. Kvien ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Certolizumab Pegol ◽  
Response Relationship ◽  
Low Disease Activity ◽  
Exposure Response ◽  
Relationship Of

Timing and Magnitude of Initial Change in Disease Activity Score 28 Predicts the Likelihood of Achieving Low Disease Activity at 1 Year in Rheumatoid Arthritis Patients Treated with Certolizumab Pegol: A Post-hoc Analysis of the RAPID 1 Trial

2012 ◽  
Vol 39 (7) ◽  
pp. 1326-1333 ◽  
Author(s):  
DÉSIRÉE VAN DER HEIJDE ◽  
EDWARD C. KEYSTONE ◽  
JEFFREY R. CURTIS ◽  
ROBERT B. LANDEWÉ ◽  
MICHAEL H. SCHIFF ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Disease Activity Score ◽  
Certolizumab Pegol ◽  
Activity Score ◽  
Clinical Trial Registration ◽  
Low Disease Activity ◽  
Post Hoc Analysis ◽  
Link Type ◽  
Post Hoc

Objective.To determine the relationship between timing and magnitude of Disease Activity Score [DAS28(ESR)] nonresponse (DAS28 improvement thresholds not reached) during the first 12 weeks of treatment with certolizumab pegol (CZP) plus methotrexate, and the likelihood of achieving low disease activity (LDA) at 1 year in patients with rheumatoid arthritis.Methods.In a post-hoc analysis of the RAPID 1 study, patients achieving LDA [DAS28(ESR) ≤ 3.2] at Year 1 were assessed according to DAS28 nonresponse at various timepoints within the first 12 weeks.Results.Seven-hundred eighty-three patients were included (CZP 200 mg, n = 393; CZP 400 mg, n = 390). A total of 86.9% of patients in the CZP 200 mg group had a DAS28 improvement of ≥ 1.2 by Week 12. Of the 13.1% of patients with DAS28 improvement < 1.2 by Week 12, only 2.0% had LDA at Year 1. Failure to achieve LDA at Year 1 depended on timing of nonresponse — 22.3%, 8.4%, and 2.0% of patients with DAS28 improvement < 1.2 by Weeks 1, 6, and 12, respectively, had LDA at Year 1 — and magnitude of initial lack of DAS28 improvement; for example, compared with the patients with DAS28 < 1.2 improvement, fewer patients with DAS28 < 0.6 had LDA at Year 1 (17.4%, 2.4%, and 0.0% at Weeks 1, 6, and 12, respectively).Conclusion.Failure to achieve improvement in DAS28 within the first 12 weeks of therapy was predictive of a low probability of achieving LDA at Year 1. Moreover, the accuracy of the prediction was found to be strongly dependent on the magnitude and timing of the lack of the response. (Clinical Trial Registration Nos. NCT00152386 and NCT00175877).

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