Britain’s National Institute for Health and Care Excellence (NICE) has issued a final guidance recommending the use of seven specific biological disease modifying drugs (DMARDs) as options for treating severe rheumatoid arthritis (RA) which doesn’t respond to intensive therapy in combination with conventional DMARDs. The recommendation specifically excludes moderate active RA (compared to severe RA), according to a press release.
The final guidance recommends methotrexate in combination with:
- abatacept (Orencia, Bristol-Myers Squibb);
- tocilizumab (RoActemra, Roche);
- golimumab (Simponi, Merck Sharp & Dohme);
- certolizumab pegol (Cimzia, UCB Pharma);
- infliximab (Inflectra, Hospira UK, Remsima, Remicade, Napp Pharmaceuticals, Merck Sharp & Dohme);
- etanercept (Enbrel, Pfizer); and
- adalimumab (Humira, AbbVie).
The guidance also recommends these monotherapy drugs for patients who cannot take methotrexate:
- tocilizumab, certolizumab pegol, etanercept, or adalimumab.
NICE’s guidance states that treatments should start with the least expensive drug, taking administration costs, doses needed, and product price in consideration.
The NICE Guideline for Rheumatoid Arthritis recommends that newly diagnosed patients begin – within three months of onset – to take a combination of conventional DMARDs (including methotrexate and one other conventional DMARD in addition to short-term glucocorticoids) as first-line treatment. Treatment for RA usually comprises non-steroidal, anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors — which reduce pain, fever, and joint swelling and inflammation — and DMARDs. The latter are used to slow the disease process and reduce joint damage.
Traditionally, people are prescribed methotrexate, leflunomide, and sulfasalazine (referred to as conventional DMARDs) but a group of drugs including monoclonal antibodies and soluble receptors that modify the disease process by blocking key protein messenger molecules (such as cytokines) or cells (such as B lymphocytes) are now referred to as biological DMARDs, important for sequential treatment if conventional DMARDs lose their effect over time or for non-responsive patients to conventional therapy.
“This guidance considers at what stage it’s clinically and cost effective to start using biological therapies as treatment options for adults with rheumatoid arthritis,” said Prof. Carole Longson, MBE, director of the Health Technology Evaluation Centre at NICE. “In recommending them as options for people with severe rheumatoid arthritis after previous treatment with conventional DMARDs has been unsuccessful, this guidance reaffirms our previous recommendations on these drugs and confirms their place as an integral part of the rheumatoid arthritis treatment pathway.”