Biologic Disease Modifying Anti Rheumatic Drugs (DMARD)

by Dr Arvind Chopra

A NEW ERA OF TARGET THERAPY
Disclaimer : These are clinical practice guidelines and general information for patients. It is mandatory to consult rheumatologist prior to therapeutic use

SUMMARY POINTS:

• DMARDs are special drugs that act on the immune system to reduce the signs and symptoms and bone damage and other systemic complications of autoimmune inflammatory arthritis disorders like rheumatoid arthritis and ankylosing spondylitis.
• DMARDs unlike pain killers (Crocin™), steroids (wysolone™) and anti-inflammatory drugs (like Voveran™ and Naprosyn™ ) are slow acting and may take several weeks to months to show optimum effect.
• Over time, long term use of DMARDs leads to good control of disease with reduction in requirement of pain killers, steroids and anti-inflammatory drugs.
• DMARDs are prescribed by specialists like rheumatologists and need careful supervision and repeated monitoring (including blood tests) to check for efficacy and drug related side effects.
• Blood cells and hemoglobin, and functions of liver and kidney need to be carefully monitored and care needed to avoid infections; uncommonly skin reactions and gut related effects may be seen.
• Traditional DMARD include methotrexate, hydroxychloroquin, sulfasalazine and leflunomide.
• In recent times, biological DMARDs with very specific and potent therapeutic effect on some important component of the immune system have been introduced to treat several types of  bad severe arthritis.
• Biologic DMARD are very effective in the management of rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and several other inflammatory arthritis and can produce complete control/remission in several patients.
• They target specific components (such as cytokines, cells, and receptors) of the body's immune system that are responsible for the severity and complications.
• Biologic DMARDs control the symptoms rapidly and the effect can be very dramatic.
• The decision to start biologic DMARD is  taken with utmost care by the rheumatologist after detail evaluation of several clinical, investigation and socioeconomic factors.
• RA and similar inflammatory arthritis are lifelong disorders and need long term medication and therefore the rheumatologist will carefully decide how long to take biologic DMARD as per an individual case.
• Biologic DMARD can be used for a short course to quickly control the disease flare and severity but this needs expert handling by the rheumatologist.
• Single or few injections for just symptomatic relief are not recommended.
• Patients on biologic DMARD may also require several other medicines (such as analgesics, anti-inflammatory (NSAIDs), immunosuppressive, conventional DMARD, iron-calcium supplements etc) but the need becomes lesser in time as arthritis improves.
• All patients on Biologic DMARD are closely monitored to ensure improvement and detect any early drug toxicity; repeated laboratory blood tests are required.
• Biologic DMARD are not pain killers but through superior disease control often reduce the requirement of analgesics and steroids; the requirement may become nil.
• Biologic DMARDs increase the risk for infections including   tuberculosis.
• Compared to routine DMARD and steroids, biologic DMARDs are much more safer; side effects connected with gut, liver, lungs and heart  are uncommon
• Biologic DMARD, especially if begun early,  effectively prevent or at least reduce the chances of  several bad complications of rheumatoid arthritis and other inflammatory arthritis such as  joint deformities, osteoporosis, and ischemic cardiac and blood circulation disorders.
• Only rheumatologists are authorized to prescribe and use biologic DMARD.
• Biologic DMARD are expensive drugs but there are several schemes announced by the manufacturers from time to time to enable some patients to afford them.
• In recent times, several companies in India are engaged in research and development of BIOSIMILAR DMARDs. Though differing in precise formula, Biosimilar drugs are considered equivalent to original Biological drugs in efficacy and safety and also approved after stringent evaluation by drug regulatory authorities. Biosimilars of Infliximab, etanercept, adalimumab and rituximab are now available in India are likely to cost less than original Biologic drugs.

Note: The above is an outline and rheumatologist needs to be consulted prior to prescribing biologic DMARD.See text for abbreviations; RA: rheumatoid arthritis; JIA: juvenile idiopathic arthritis; AS: ankylosing spondylitis;  SSA: seronegative spondyloarthritis; # the duration of the initial regimen use has been empirically worked out in Center for Rheumatic Diseases, Pune to control the intensity of the disease in a socioencomical and scientific manner; however the patients will continue to use oral traditional DMARD for long term control.
NOTE: the dose of biologic agent shown above is usually used to treat RA and may differs in other forms of arthritis.

Biologic DMARD	Trade Name	Target	App Cost per unit	Indications	Usuals Single Dose for adults 60kg	Initial Regimen#
Infliximab	Remicade	TNF	Rs 32,000/=per 100 gm via(as per 4 months course)	RA, JIA, AS, SSA, Psoriasis Arthritis, Inflammatory COlitis-Arthritis	200-300 mg infused intravenously every 4-6 weeks	3-4 doses over 12-20 weeks
Etanercept	Enbrel	TNF	Rs 14,000/=per 50 gm vial	RA, JIA, AS, SSA, Psoriasis	50 mg injection subcutaneous weekly	12-16 weeks
Rituximab	Mabthera, (Ristova)	B cell	Rs 28,000/= per 500 gm vial	RA	1 gm start and repeat after 2 weeks; given as intravenous infusion	Give once in 6 months to one year
Tocilizumab	Actemra	IL-6	Rs 15,000/= for 200 mg vial	RA, JIA	8 mg/kg Body wt; intravenous infusion monthly	At least 4-6 doses over 4-6 months
Abatacept	Orencia	T cell	Rs 22,500/= for 250 mg vial	RA, JIA, AS, SSA, Psoriasis	750 mg intravenous infusion every 2-4 weeks	3-4 doses over 12 weeks
Itolizumab	Alzumab	CD 6	Rs 7000/= for 25 mg vial	Psoriasis arthritis, RA(under evalution)	1.6 mg/kg body wt intraveneous infusions infused every monthly	twice monthly infusion for 3 months and then monthly for 6 months
Note: The above is an outline and rheumatologist needs to be consulted prior to prescribing biologic DMARD. See text for abbreviations; RA: rheumatoid arthritis; JIA: juvenile idiopathic arthritis; AS: ankylosing spondylitis; SSA: seronegative spondyloarthritis; # the duration of the initial regimen use has been empirically worked out in Center for Rheumatic Diseases, Pune to control the intensity of the disease in a socioencomical and scientific manner; however the patients will continue to use oral traditional DMARD for long term control NOTE: the dose of biologic agent shown above is usually used to treat RA and may differs in other forms of arthritis.