New Guidelines For Rheumatoid Arthritis – Good Or Bad?
The American College of Rheumatology (ACR) is the national organization that represents much of the current thinking when it comes to arthritis care. One of their major commitments has been to develop guidelines for treatment of various types of arthritis. These guidelines are meant to instruct and perhaps give people an indication of what is considered “standard of care”.
They are not set in concrete nor are they meant to restrict other therapies. Guidelines for the treatment of rheumatoid arthritis (RA) were last made by the ACR in 2002… before the general use of biologic therapy.
Rheumatoid arthritis is a chronic, systemic, autoimmune disorder for which there is no known cure. It affects roughly 2 million Americans.
Up until the turn of this past century, disease-modifying anti-rheumatic drugs (DMARDS) were the mainstay of treatment. Because of the advent of newer more effective biologic therapies, the ACR felt it was time for a major re-evaluation of the use of DMARD therapy in rheumatoid arthritis.
They issued a set of guidelines that were recently published. (Saag KG, et al. Arthritis Care and Research 2008; 59: 762-784).
These recommendations on the use of non-biologic and biologic DMARDs in RA have recently been published and focus on 5 key areas: indications for use, monitoring for side-effects, assessing the 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. When formulating these recommendations, RA disease duration, disease severity, and prognostic features were also considered.
The authors of these guidelines stated that, “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.”
The ACR 2008 recommendations include:
o Initiation of methotrexate or leflunomide (Arava) therapy was recommended for most RA patients.
o Methotrexate plus hydroxychloroquine (Plaquenil) was also endorsed for patients with moderate to high disease activity.
o The triple DMARD combination of methotrexate plus hydroxychloroquine plus sulfasalazine (Azulfidine) for patients with poor prognostic features and moderate to high levels of disease activity was suggested.
o Recommended the prescription of anti-TNF agents such as etanercept (Enbrel), infliximab (Remicade), or adalimumab (Humira) 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 were recommended for patients who had failed to respond adequately to methotrexate therapy.
o Reserving the use of second line biologic therapies such as abatacept (Orencia) and rituximab (Rituxan) for patients with at least moderate disease activity and poor disease prognosis for whom methotrexate in combination with or sequential administration of other non-biologic DMARDs did not lead to an adequate response.
o 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.
o 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.
o Avoiding the initiation or resumption of methotrexate, leflunomide, or minocycline for RA patients planning for pregnancy and throughout the duration of pregnancy and breastfeeding.
The authors continued on, “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.”
Personally, I feel the guidelines are too little too late. While I agree with the main body of their recommendations for the most part, I do disagree with some of their thoughts. For instance, I have disagreement with the use of triple therapy since I don’t think it works and is potentially more toxic than the use of biologic therapies. In addition, the use of second-line drugs like Orencia and Rituxan should be given to patients who fail the combination of a TNF-inhibitor and methotrexate.
Newer biologic agents such as Actemra and Cimzia which are currently awaiting FDA approval will also alter the way rheumatologists approach treatment.
Progress in the field of rheumatoid arthritis research has been astounding. With the advent of newer techniques designed to diagnose and customize therapies, the possibility of a cure is not too far down the road.