Publications

Long-term clinical outcomes of certolizumab pegol treatment in non-radiographic axial spondyloarthritis stratified by baseline MRI and CRP status

RMD Open 2024;10:e003884 doi: 10.1136/rmdopen-2023-003884 https://pubmed.ncbi.nlm.nih.gov/38724259/

Rudwaleit M,

Deodhar A,

Bauer L,

Gensler L,

Hoepken B,

Kumke T,

Auteri SE,

Kim M,

Maksymowych W

The safety follow-up extension of the C-axSpAnd trial showed that long-term clinical outcomes from certolizumab pegol treatment achieved after 1 year were generally sustained at 3 years across MRI+/CRP+, MRI−/CRP+ and MRI+/CRP− subgroups.

Keywords:

• ASAS,
• Efficacy,
• Remission,
• Phase 3

Certolizumab pegol for the treatment of chronic plaque psoriasis: results through 48 weeks from 2 Phase 3, multicenter, randomized, double-blinded, placebo-controlled studies (CIMPASI-1 and CIMPASI-2)

J Am Acad Dermatol 2018;79:302–14. doi: 10.1016/j.jaad.2018.04.012

Gottlieb A,

Blauvelt A,

Thac D,

Leonardi C,

Poulin Y,

Janice Drew J,

Luke Peterson L,

Arendt C,

Burge D,

Reich K

Treatment of moderate-to-severe chronic plaque PsO with either CZP 400 mg or 200 mg Q2W was associated with significant, clinically meaningful improvements in efficacy and quality of life that were maintained over time compared with placebo. Safety findings were in line with those expected of the therapy.

Keywords:

• Efficacy,
• Phase 3,
• Safety,
• Certolizumab

Certolizumab pegol for the treatment of chronic plaque psoriasis: Results through 48 weeks of a Phase 3, multicenter, randomized, double-blind, etanercept- and placebo-controlled study (CIMPACT)

J Am Acad Dermatol 2018;79:266–76. doi: 10.1016/j.jaad.2018.04.013

Lebwohl M,

Blauvelt A,

Paul C,

Sofen H,

Węgłowska J,

Piguet V,

Burge D,

Rolleri R,

Drew J,

Peterson L,

Augustin M

In this phase 3 study, both 200mg and 400mg certolizumab pegol doses improved psoriasis symptoms at Week 12 measured via PASI 75. Improvement was maintained, after rerandomisation, through Week 48, with a safety profile consistent with its drug class. This Phase 3 CIMPACT trial by Lebwohl et al., assessed the safety and efficacy of certolizumab pegol for the treatment of moderate-to-severe chronic plaque psoriasis.

Keywords:

• Efficacy,
• Phase 3,
• Safety,
• TNF

Certolizumab Pegol Efficacy in Patients with Non-Radiographic Axial Spondyloarthritis Stratified by Baseline MRI and C-Reactive Protein Status: An Analysis From the C-axSp And Study

ACR Open Rheumatol. 2022 doi: 10.1002/acr2.11469

Robinson PC,

Maksymowych WP,

Gensler LS,

Hall S,

Rudwaleit M,

Hoepken B,

Bauer L,

Kumke T,

Kim M,

de Peyrecave N,

Deodhar A

The results of this analysis indicated that certolizumab pegol (CZP) treatment benefits patients with nr-axSpA across all the MRI/CRP subgroups studied. To reach this conclusion, this study evaluated clinical responses to CZP in patients with nr-axSpA stratified by baseline MRI/CRP status.

Network Meta‐Analysis of Tofacitinib versus Biologic Treatments in Moderate‐to‐Severe Rheumatoid Arthritis Patients

J Clin Pharm Ther. 2019 Jun;44(3):384-396.

Camean‐Castillo M,

Gimeno‐Ballester V,

Rios‐Sanchez E,

Fenix‐Caballero S,

Vázquez‐Real M,

Alegre‐del Rey E

This study suggests that many bDMARDs and tsDMARDs can be considered equivalent therapeutic alternatives in bDMARD-naïve RA patients, with inadequate response to csDMARDs.In the absence of randomised controlled trials comparing drugs, indirect comparisons and network meta-analysis may provide information to help select an optimal treatment alternative. In this network meta-analysis, 27 randomized controlled trials were analysed to assess the possibility that some drugs on the market may be consi...

Keywords:

• JAK,
• Tildrakizumab,
• Efficacy,
• Safety,
• Meta Analysis

Efficacy of Monotherapy with Biologics and JAK inhibitors for the Treatment of Rheumatoid Arthritis: A Systematic Review

ADV Ther 2018; 35(10):1525–63 DOI: 10.1007/s12325-018-0757-2

Emery P,

Pope JE,

Kruger K,

Lippe R,

DeMasi R,

Lula S,

Kola B

The b/tsDMARDs evaluated in this systematic literature review (SLR) were shown to be efficacious as monotherapies, although combination therapies usually achieved better treatment outcomes.Current treatment guidelines recommend combining b/tsDMARDs with MTX in the treatment of RA; however, up to a third of patients are treated with monotherapy. While previous SLRs1–3 have compared the efficacy of b/tsDMARD mono- versus MTX combination therapy they covered a limited number of randomised controlle...

Keywords:

• JAK,
• Review

Biologic or Tofacitinib Monotherapy for Rheumatoid Arthritis in People with Traditional Disease-modifying Anti-rheumatic Drug (DMARD) Failure: a Cochrane Systematic Review and Network meta-analysis (NMA)

Cochrane Database Syst Rev 2016;11:CD012437.

Singh JA,

Hossain A,

Tanjong Ghogomu E,

Mudano AS,

Tugwell P,

Wells GA

Treatment options for RA patients who are MTX/DMARD incomplete responders (IR) include other DMARDs, biologics or tofacitinib (TOF). However, there is a lack of direct head-to-head comparator trials of biologics in people with RA. This review provides an update of the 2009 Cochrane overview, ‘Biologics for rheumatoid arthritis’,1 and provides comparisons and estimates for biologic or TOF monotherapy in MTX/DMARD-IR people with RA.The benefits and harms of biologic monotherapy (TNFis: adalimumab,...

Keywords:

• JAK,
• Tofacitinib,
• Meta Analysis

Biologics or Tofacitinib for Rheumatoid Arthritis in Incomplete Responders to Methotrexate or Other Traditional Disease-Modifying Anti-Rheumatic Drugs: A Systematic Review and Network Meta-Analysis

Cochrane Database of Systematic Reviews 2016 Issue 5. Art. No.: CD012183 [DOI: 10.1002/14651858.CD012183].

Singh et al

Treatment options for RA patients who are MTX/DMARD incomplete responders (IR) include other DMARDs, biologics or tofacitinib (TOF). However, there is a lack of head-to-head studies to show any important differences between these options in terms of benefits and harms. This review provides an update of the 2009 Cochrane overview and network meta-analysis (NMA) of biologics for RA.1Nine biologics (abatacept, adalimumab, anakinra, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, a...

Keywords:

• JAK,
• Tofacitinib,
• Meta Analysis

Efficacy and Safety of Tofacitinib as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis: A 12-Week, Randomized, Phase 2 Study

Mod Rheumatol. 2014 Dec 11:1–25. [Epub ahead of print]

Tanaka Y,

Takeuchi T,

Yamanaka H,

Nakamura H,

Toyoizumi S,

Zwillich S.

In Japan, the biologic DMARDs infliximab, etanercept, adalimumab, golimumab and certolizumab pegol, as well as tocilizumab and abatacept are approved for use in patients with active RA and an inadequate response to existing therapies. However, not all patients respond to these therapies adequately, creating an unmet need for therapeutic options with alternative mechanisms of action.

The oral JAK inhibitor tofacitinib has demonstrated efficacy as monotherapy or in combination with DMARDs ...

Keywords:

• JAK,
• Tofacitinib,
• Phase 2