Novel Therapies in Rheumatoid Arthritis

Early achievement of disease remission is critical to the successful management of rheumatoid arthritis (RA). A symposium presented at the Asembia Specialty Pharmacy Summit 2018 provided pharmacists a review of guideline-based RA management strategies, along with recent trial data on new and emerging agents. After providing an overview of the disease and diagnosis, the presentation reviewed the 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis and highlighted the upcoming release of new guidelines in 2019. Baseline assessment of RA should include complete blood count, serum creatinine, aminotransferases, erythrocyte sedimentation rate, C-reactive protein, hepatitis B and C, ophthalmologic screening, and tuberculosis screening.

Monitoring is critical during therapy and should include efficacy measures (ie, disease activity scale), adverse drug events, and patient-centered outcomes. In addition to these provisions, the American College of Rheumatology guidelines recommend initiation of a disease-modifying antirheumatic drug (DMARD) as soon as possible, with a treat-to-target of low or remission of disease activity. Choice of DMARD should depend on level of disease activity, presence of comorbid conditions, stage of therapy, regulatory restrictions, patient preference, and presence of adverse prognostic signs.

The first-line agent should be metho- trexate (MTX), with leflunomide, sulfasalazine, or hydroxychloroquine as an alternative. If monotherapy is not sufficient to reach the target goal, triple therapy or MTX plus a tumor necrosis factor-alpha (TNF-alpha) inhibitor should be considered. Patients with RA who fail MTX with 2 different TNF- alpha inhibitors should try MTX with abatacept, tocilizumab, rituximab, or tofacitinib. The presentation provided updated data on several major clinical trials, including triple therapy versus MTX/TNF-alpha, MTX/TNF-alpha versus MTX/abatacept, and rituximab versus TNF-alpha. Additional considerations for biologic and nonbiologic DMARDs were also addressed.

Emerging therapies included 2 Janus kinase inhibitors, tofacitinib and baricitinib, and anti—IL-6 agents tocilizumab and sarilumab. Both tofacitinib and baricitinib have shown superiority to MTX in DMARD-naïve patients. In late-stage clinical trials, tocilizumab monotherapy showed less radiographic change than traditional DMARDs at week 52 of therapy and was superior to MTX at all time points. Additionally, tocilizumab plus DMARD showed more positive response than DMARD alone at week 24 of treatment.

Sarilumab monotherapy showed less radiographic change than traditional DMARDs at week 52 of therapy. After reviewing emerging therapies, the presentation reviewed the biosimilar product landscape, the Biologics Price Competition and Innovation Act, the Purple Book, state regulations, and FDA-approved biosimilars. The symposium concluded with a section on patient-reported outcomes. Pharmacists were advised that appropriate disease management in RA focuses not just on minimizing disease progression but also on the patient’s ability to manage pain, physical function, and fatigue. Pharmacists must bear in mind that personal, subjective disease burdens affect the overall perspective of disease management and are critical to successful patient care.