Biologic and Oral DMARD Monotherapy in RA
Biologic and Oral DMARD Monotherapy in RA
Clinical evidence demonstrates coadministration of tumour necrosis factor inhibitor (TNFi) agents and methotrexate (MTX) is more efficacious than administration of TNFi agents alone in patients with rheumatoid arthritis, leading to the perception that coadministration of MTX with all biologic agents or oral disease-modifying antirheumatic drugs is necessary for maximum efficacy. Real-life registry data reveal approximately one-third of patients taking biologic agents use them as monotherapy. Additionally, an analysis of healthcare claims data showed that when MTX was prescribed in conjunction with a biologic agent, as many as 58% of patients did not collect the MTX prescription. Given this discrepancy between perception and real life, we conducted a review of the peer-reviewed literature and rheumatology medical congress abstracts to determine whether data support biologic monotherapy as a treatment option for patients with rheumatoid arthritis. Our analysis suggests only for tocilizumab is there evidence that the efficacy of biologic monotherapy is comparable with combination therapy with MTX.
Methotrexate (MTX), administered alone or with another conventional disease-modifying antirheumatic drug (DMARD), is the recommended first-line treatment for patients with rheumatoid arthritis (RA). MTX plus tumour necrosis factor inhibitor (TNFi) agents is the usual treatment for patients with RA with insufficient response to MTX/DMARDs (MTX-/DMARD-IR). TNFi agents plus MTX reduce disease activity, improve physical function and attenuate radiographic progression in MTX/DMARD-IR patients. When administered with MTX, enhanced efficacy has been observed for TNFi agents infliximab, etanercept, adalimumab and golimumab. The efficacy reported with certolizumab in combination with MTX is higher than that reported in separate studies with certolizumab monotherapy. The non-TNFi agent rituximab, which targets CD20 B cells, may also be more effective when combined with MTX. Despite the efficacy of TNFi agents plus conventional DMARDs and the limited approval of biologics (etanercept, adalimumab, certolizumab, tocilizumab) as monotherapy, biologic monotherapy for managing RA is widespread in clinical practice.
Review of the peer-reviewed published literature (2005–2012) and rheumatology medical congress abstracts (European League Against Rheumatism and American College of Rheumatology (ACR), 2009–2012) was conducted to determine potential reasons for, and evidence supporting, the use of biologics or oral DMARDs (tofacitinib) as monotherapy (Box 1). References in retrieved articles were reviewed to identify trials in which biologics alone were administered. Additional search strategies to identify potential reasons for use of biologics as monotherapy were conducted.
Abstract and Introduction
Abstract
Clinical evidence demonstrates coadministration of tumour necrosis factor inhibitor (TNFi) agents and methotrexate (MTX) is more efficacious than administration of TNFi agents alone in patients with rheumatoid arthritis, leading to the perception that coadministration of MTX with all biologic agents or oral disease-modifying antirheumatic drugs is necessary for maximum efficacy. Real-life registry data reveal approximately one-third of patients taking biologic agents use them as monotherapy. Additionally, an analysis of healthcare claims data showed that when MTX was prescribed in conjunction with a biologic agent, as many as 58% of patients did not collect the MTX prescription. Given this discrepancy between perception and real life, we conducted a review of the peer-reviewed literature and rheumatology medical congress abstracts to determine whether data support biologic monotherapy as a treatment option for patients with rheumatoid arthritis. Our analysis suggests only for tocilizumab is there evidence that the efficacy of biologic monotherapy is comparable with combination therapy with MTX.
Introduction
Methotrexate (MTX), administered alone or with another conventional disease-modifying antirheumatic drug (DMARD), is the recommended first-line treatment for patients with rheumatoid arthritis (RA). MTX plus tumour necrosis factor inhibitor (TNFi) agents is the usual treatment for patients with RA with insufficient response to MTX/DMARDs (MTX-/DMARD-IR). TNFi agents plus MTX reduce disease activity, improve physical function and attenuate radiographic progression in MTX/DMARD-IR patients. When administered with MTX, enhanced efficacy has been observed for TNFi agents infliximab, etanercept, adalimumab and golimumab. The efficacy reported with certolizumab in combination with MTX is higher than that reported in separate studies with certolizumab monotherapy. The non-TNFi agent rituximab, which targets CD20 B cells, may also be more effective when combined with MTX. Despite the efficacy of TNFi agents plus conventional DMARDs and the limited approval of biologics (etanercept, adalimumab, certolizumab, tocilizumab) as monotherapy, biologic monotherapy for managing RA is widespread in clinical practice.
Review of the peer-reviewed published literature (2005–2012) and rheumatology medical congress abstracts (European League Against Rheumatism and American College of Rheumatology (ACR), 2009–2012) was conducted to determine potential reasons for, and evidence supporting, the use of biologics or oral DMARDs (tofacitinib) as monotherapy (Box 1). References in retrieved articles were reviewed to identify trials in which biologics alone were administered. Additional search strategies to identify potential reasons for use of biologics as monotherapy were conducted.
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