After more than a decade without a single new drug to treat rheumatoid arthritis, three new RA medications are either available or will be shortly. The past year has also seen the introduction of two new options for the treatment of OA and progress in the development of safer anti-inflammatory medications.
In its November-December issue, Arthritis Today reports on these new arthritis treatment options. At press time, a few of the drugs were awaiting FDA approval, and some specifics about certain drugs were lacking.
To provide you with the latest information on these drugs, Arthritis Today will update this Web site as developments occur. For more details about the drugs, including a question-and-answer feature on what they are and who will likely benefit the most from them, see "The New Drugs: What to Expect" in the current issue of AT.
 | For Rheumatoid Arthritis: |
| For Pain and Inflammation: |
| For Osteoarthritis: |
| Old Drugs with New Roles: |
| Drug: etanercept |
| Brand name: Enbrel |
| FDA Status: Approved for moderately to severely active rheumatoid arthritis |
| Category: Biologic (specifically, anti-TNF) agent |
| What it does: Inhibits the action of tumor necrosis factor (TNF), a chemical believed to play an important role in driving the process of inflammation and tissue damage in RA |
| Who should use it: People with severe RA who have not experienced significant relief with their current medications |
| Who shouldn't use it: People who are getting satisfactory results from other treatments; people who have a serious infection or who are allergic to etanercept or any of its components |
| How it's taken: Twice weekly in 25 mg subcutaneous (just beneath the skin) injections; medication may be sold in pre-filled syringes; may be given in conjunction with methotrexate for people whose RA does not respond adequately to methotrexate alone. |
| Special instructions: Drug must be refrigerated, because it is a natural protein that can break down at room temperature; shots may be given at home by you or a partner or caregiver. |
| Cost: about $220 weekly, or $11,440 per year |
| Other factors to consider: Because of the drug's expense, it may not be covered by some health insurance plans. Frequent lab tests are necessary, at least initially, to monitor effects on the body. |
| Drug: infliximab |
| Brand name: Remicade (formerly Avakine) |
| FDA status: approved for Crohn's disease; approval for RA expected by late 1999 |
| Category: biologic (specifically, anti-TNF) agent |
| What it does: Inhibits the action of tumor necrosis factor (TNF), a chemical believed to play an important role in driving the process of inflammation and tissue damage in RA |
| Who should use it: People with severe RA who have not experienced significant relief with their current medications |
| Who shouldn't use it: People who are getting satisfactory results from other treatments; people who have a serious infection or who are allergic to etanercept or any of its components |
| How it's taken: intravenously in a two-hour outpatient procedure |
| Special instructions: must be administered by a health-care professional; dose is based on weight; will likely be given along with methotrexate |
| Cost: not yet available; will differ with dosage based on person's weight |
| Other factors to consider: Because of the drug's expense, it may not be covered by some health insurance plans. Frequent lab tests are necessary, at least initially, to monitor effects on the body. |
| Drug: leflunomide |
| Brand name: Arava |
| FDA Status: approved for rheumatoid arthritis |
| Category: disease-modifying anti-rheumatic drug (DMARD) |
| What it does: affects the function of immune cells called T lymphocytes |
| Who should use it: people with active RA |
| Who shouldn't use it: people with active infection, liver disease or known immune deficiency; children; women who are pregnant or nursing; either member of a couple who is wishing to or who might potentially conceive a child while on the medication. (Women or men who are taking leflunomide and would like to have a child should stop the medication and go through an 11-day drug elimination process using the cholesterol-lowering drug, cholestyramine.) |
| How it's taken: orally, once a day in 10, 20 or 100 mg tablets. Typically prescribed in a "loading" dose of 100 mg daily for the first three days, then 20 mg daily after that. People who experience side effects may have their dose lowered to 10 mg daily. |
| Special instructions: Can be taken with other medications such as glucocorticoids, vitamins and birth control pills. |
| Cost: approximately $240 per month, or $2,880 per year |
| Other factors to consider: Frequent lab tests are necessary, at least initially, to monitor effects on body; because the drug is new, there is no data available on potential long-term side effects. In laboratory animals use of leflunomide has been shown to cause birth defects. |
Click HERE for much more on Celebrex
| Drug: celecoxib |
| Brand name: Celebrex (formerly Celebra) |
| FDA Status: Phase III data under review by FDA; approval may come as early as December 1998 |
| Category: COX-2 inhibitors, a sub-category of nonsteroidal anti-inflammatory drugs (NSAIDs) |
| What it does: helps relieve pain and inflammation |
| Who should use it: people with conditions involving pain and inflammation, particularly those requiring NSAIDs and for whom traditional NSAIDs have caused stomach problems. |
| Who shouldn't use it: no information available, pending FDA approval |
| How it's taken: orally; dosage information unavailable, pending FDA approval |
| Special instructions : no information available, pending FDA approval |
| Cost: no information available |
| Other factors to consider: Although drugs in this class have commonly been referred to as "super aspirins," as yet there is no evidence that these drugs provide aspirin's protection against heart attack or stroke. |
| Drug: rofecoxib |
| Brand name: Vioxx |
| FDA Status: No information available |
| Category: COX-2 inhibitors, a sub-category of NSAIDs |
| What it does: helps relieve pain and inflammation |
| Who should use it: see celecoxib, above |
| Who shouldn't use it: no information available |
| How it's taken: Orally, once daily in doses of 5, 12.5, 25 or 50 mg |
| Special instructions: no information available |
| Cost: no information available |
| Other factors to consider: see celecoxib above |
| Drug: hyaluronan |
| Brand name: Hyalgan |
| FDA Status: approved as a medical device for OA of the knee |
| Category: viscosupplement /hyaluronic acid substitute (FDA approved as a medical device) |
| What it does: serves a substitute for the natural hyaluronic acid in the joint fluid, which breaks down in people with OA. Hyaluronic acid is believed to lubricate and act as a shock absorber in the joint. Hyaluronan has been shown to relieve pain from knee OA for up to 12 months. |
| Who should use it: people with OA of the knee for whom analgesic medications and other measures, such as exercise, fail to provide adequate relief |
| Who shouldn't use it: anyone with a skin disease or infection at the injection site. Products should be administered with caution to patients with allergic to avian proteins, feathers and egg products. |
| How it's taken: in a series of five injections directly into the knee joint(s), given one shot per week; because hyaluronan is a thick substance requiring a large-gauge needle, a local anesthetic is injected beforehand to ease the discomfort of the hyaluronan injection. Patients should avoid any strenuous activities or prolonged weight-bearing activities for 48 hours after injection. |
| Cost: $635 for five-injection series (per knee); there will likely be additional charges by the physician to administer the injection. |
| Other factors to consider: If the knee is swollen, joint fluid must be aspirated before medication can be injected. The drug preferably should be administered by a specialist, such as a rheumatologist or orthopaedic surgeon, experienced in injecting joints. Occasionally, joint damage may make it difficult or impossible for the doctor to inject the medication into the joint space. If any shot in the series causes a reaction at the injection site, future shots must be canceled. Rare allergic reactions to the substance have been reported. |
| Drug: hylan G-F20 |
| Brand name: Synvisc |
| FDA Status: approved as a medical device for OA of the knee |
| Category: Viscosupplement /hyaluronic acid substitute |
| What it does: same as hyaluronan above, except that pain relief has been documented for up to six months |
| Who should use it: people with OA of the knee for whom analgesic medications and other measures, such as exercise, fail to provide adequate relief |
| Who shouldn't use it: anyone with a skin disease or infection at the injection site. Products should be administered with caution to patients with allergic to avian proteins, feathers and egg products. |
| How it's taken: in a series of three injections directly into the knee joint(s), given one week at a time |
| Cost: $495.75 for three-injection series (per knee); there will likely be additional charges by the physician to administer the injection. |
| Other factors to consider: see hyaluronan, above |
Two of the most promising new drugs have been around a while. These have now been approved by the FDA for rheumatoid arthritis and Sjogren's syndrome.
| Drug: pilocarpine hydrochloride |
| Brand Name: Salagen Tablets |
| Category: Cholinergic agonist |
| Original Use: to ease dry mouth associated with radiation therapy for head and neck cancers |
| New Use: to treat dry mouth associated with Sjogren's syndrome |
| What it does: stimulates salivary glands, increasing saliva production |
| Potential side effects: sweating, nausea, nasal inflammation, chills, flushing, increased urinary frequency, dizziness and weakness |
| Who should use it: people with mild to moderate dry mouth |
| Who shouldn't use it: people with uncontrolled asthma, acute iritis or narrow-angle glaucoma |
| How it's taken: orally, in four daily doses of 5 mg each |
| Special instructions: Take with meals and at bedtime |
| Cost: $1 to $1.10 per pill, or about $1,500 to $1,600 per year |
| Other factors to consider: The drug is not a cure and it does not work for all people. It can take as long as 12 weeks to experience results from the drug, so you may have to use the drug a while before you know if it is going to work. |
| Drug: cyclosporine |
| Brand name: Neoral |
| Category: DMARD |
| Original Use: to prevent organ transplant rejection |
| New Use: to treat RA |
| What it does: inhibits overactive immune function that causes joint inflammation and destruction in RA |
| Potential side effects: headaches, hypertension, kidney problems, gastrointestinal disorders (nausea, diarrhea, heartburn) and facial hair growth |
| Who should use it: people with severe, active RA for whom other treatments do not provide sufficient relief |
| Who shouldn't use it: people with kidney disease |
| How it's taken: orally in 100 mg tablets twice daily (dosage may be adjusted as needed or depending on person's weight) |
| Special instructions: take two doses 12 hours apart, at the same time every day |
| Cost: approximately $10 per day, or $3,650 per year |
| Other factors to consider: Studies have shown that the drug's effectiveness may be greater when combined with methotrexate. |
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