The recommendations on the use of non-biologic and biologic DMARDs in RA address five key areas: indications for use; monitoring for side effects; assessing clinical response; screening for tuberculosis (a risk factor associated with biologic DMARDs); and under certain circumstances (i.e. high disease activity) the roles of cost and patient preference in choosing biologic agents.
The recommendations, published in the June issue of the journal Arthritis Care & Research, also take into account RA disease duration, disease severity, and prognostic features.
‘These recommendations were developed for specialist clinicians familiar with assessing RA disease activity and disease severity,’ project co-leader Dr. Kenneth Saag, professor of medicine and epidemiology at the University of Alabama at Birmingham, said in a prepared statement.
‘Applying these recommendations to clinical practice requires individualized patient assessment and clinical decision-making. The recommendations developed are not intended to be used in a ‘cookbook’ or prescriptive manner or to limit a physician's clinical judgment, but rather to provide guidance based on clinical evidence and expert panel input,’ Saag said.
The recommendations include:
- Methotrexate or leflunomide therapy is recommended for most RA patients.
- Methotrexate plus hydroxychloroquine is endorsed for patients with moderate to high disease activity.
- The triple DMARD combination of methotrexate plus hydroxychloroquine plus sulfasalazine for patients with poor prognostic features and moderate to high levels of disease activity.
- Prescribing anti-TNF agents -- etanercept, infliximab, or adalimumab -- along with methotrexate in early RA (less than 3 months) only for patients with high disease activity who had never received DMARDs. In intermediate- and longer-duration RA, anti-TNF agents are recommended for patients who had failed to respond adequately to methotrexate therapy.
- Reserving the fusion protein abatacept and the B-cell antibody rituximab for patients with at least moderate disease activity and poor disease prognosis for whom methotrexate in combination with or sequential administration of other nonbiologic DMARDs led to an inadequate response.
- Avoiding the initiation or resumption of treatment with methotrexate, leflunomide, or biologic agents for patients with active bacterial infection, active herpes-zoster viral infection, active or latent tuberculosis, or acute or chronic hepatitis B or C.
- Not prescribing anti-TNF agents to patients with a history of heart failure, with a history of lymphoma, or with multiple sclerosis or demyelinating disorders.
- Avoiding the initiation or resumption of methotrexate, leflunomide, or minocycline for RA patients planning for pregnancy and throughout the duration of pregnancy and breastfeeding.
‘These recommendations are extensive but not comprehensive, and it is intended that they will be regularly updated to reflect the rapidly growing scientific evidence in this area along with changing practice patterns in rheumatology,’ Saag said.”
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