Biosimilar tumor necrosis factor inhibitors (TNFis) were given the thumbs up in the European League Against Rheumatism (EULAR) 2015 update of its psoriatric arthritis (PsA) pharmacologic treatment recommendations.1
The US patent protection for Humira (adalimumab), the primary TNFi used in PsA, will expire at the end of this year, and biosimilars are poised to potentially take a significant share of the PsA market when they are approved in the United States.
In the fifth of EULAR's 10 recommendations, the expert team stated that when patients have an inadequate response to at least one disease-modifying antirheumatic drug (DMARD) therapy, a biologic agent, usually a TNFi, should be used.
"...Biosimilar TNFis which are approved by FDA [US Food and Drug Administration] and/or EMA [European Medicines Agency] are regarded to be similar to the respective biological originator TNFis. Indeed, a biosimilar infliximab agent has been recently approved by the European Medicines Agency based on studies in RA [rheumatoid arthritis] and ankylosing spondylitis, and extrapolated to all other indications for which infliximab has been approved," the expert team wrote. They are referring to Inflectra, which is a biosimilar manufactured by Hospira and approved in Europe in September 2013. Inflectra has also been approved in Canada, while the FDA has been reviewing the data for more than a year.
"Biosimilars will indeed allow cost savings. Costs are important to consider–alongside efficacy, safety, and patient preference–as underlined in the overarching principles [of our recommendation paper]," Laure Gossec, MD, PhD, a professor of rheumatology at Sorbonne Universités' Institut Pierre Louis d'Epidémiologie et de Santé Publique and Pitié Salpêtrière Hospital, told Value-Based Care in Rheumatology. "This is why biosimilars are put as first-line biologics right up there with originator TNF inhibitors. We did not make a distinction between bo [originator] TNFi and bs [biosimilar] TNFi."
Indeed, 1 of the 4 "overarching principles" enunciated in the paper is that shared decision-making between the rheumatologist and patient should be the basis of care, and should take into account efficacy, safety, and costs. This principle was not present in the previous recommendations.2
However, the fifth recommendation was the only one of the 10 that mentioned biosimilars; there was more focus on the new agents golimumab and certolizumab pegol and another 3 drugs with new modes of action: ustekinumab, secukinumab, and apremilast.
The authors recommend "conventional synthetic" DMARDs–a term they use to signify traditional DMARDs–as an initial therapy after failure of nonsteroidal anti-inflammatory drugs (NSAIDs) and local therapy for active disease. This should be followed if necessary by a biologic DMARD–usually a TNFi–or a "targeted synthetic" DMARD (tsDMARD).They also noted that "b [biologic] DMARDs targeting interleukin (IL)-12/23 (ustekinumab) or IL-17 pathways (secukinumab) may be used in patients for whom TNF inhibitors are inappropriate and a tsDMARD such as a phosphodiesterase 4-inhibitor (apremilast) if bDMARDs are inappropriate. If the first bDMARD strategy fails, any other bDMARD or tsDMARD may be used."
Dr Gossec was a member of the steering group, which was in charge of the literature review and the overall recommendation formulation process. In addition, a 34-member task force-including 3 people with PsA–met with the steering group to arrive at a consensus regarding the proposed recommendations, overarching principles, and a treatment algorithm. There was a high level of agreement on all of the recommendations and principles.
Among other new elements of the recommendations are that:
- Treatment should be adjusted based on regular disease monitoring, to achieve remission or minimal/low disease activity
- Patients with predominantly axial PsA that is active and has not responded to NSAIDs can be given a TNFi
- Those who do not respond adequately to a bDMARD can be switched to another bDMARD, including to another TNFi.
All of the overarching principles and recommendations are reflected in the algorithm, which takes the complicated task of treating the various manifestations of PsA and puts it into an easy-to-follow diagram.
- Gossec L, Smolen JS, Ramiro S, et al. European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update [published online December 11, 2015]. Ann Rheum Dis. doi: 10.1136/annrheumdis-2015-208337.
- Gossec L, Smolen JS, Gaujoux-Viala C, et al; European League Against Rheumatism. European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies. Ann Rheum Dis. 2012;71:4-12.