General Information

Mobic (meloxicam) is a non-steroidal anti-inflammatory drug (NSAID).

Mobic is specifically indicated for:

• relief of the signs and symptoms of osteoarthritis
• relief of the signs and symptoms of rheumatoid arthritis
• relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients who weigh ≥60 kg

Mobic is supplied as tablets for oral administration. In adults, the maximum recommended daily oral dose of Mobic is 15 mg regardless of formulation. In patients with hemodialysis, a maximum daily dosage of 7.5 mg is recommended. Mobic may be taken without regard to timing of meals.

The recommended dosing is as follows:

Osteoarthritis

• For the relief of the signs and symptoms of osteoarthritis the recommended starting and maintenance oral dose of Mobic is 7.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 15 mg once daily.

Rheumatoid Arthritis

• For the relief of the signs and symptoms of rheumatoid arthritis, the recommended starting and maintenance oral dose of Mobic is 7.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 15 mg once daily.

Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course

• For the treatment of juvenile rheumatoid arthritis, the recommended oral dose of Mobic is 7.5 mg once daily in children who weigh ≥60 kg. There was no additional benefit demonstrated by increasing the dose above 7.5 mg in clinical trials. Mobic tablets should not be used in children who weigh <60 kg.

Mechanism of Action

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities in models. The mechanism of action of meloxicam, like that of other NSAIDs, may be related to prostaglandin synthetase (cyclooxygenase) inhibition.

Side Effects

Adverse effects associated with the use of Mobic may include, but are not limited to, the following:

• diarrhea
• upper respiratory tract infections
• dyspepsia
• influenza like symptoms

The Mobic drug label comes with the following Black Box Warning: Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Mobic is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

Clinical Trial Results

Osteoarthritis

A double-blind, controlled study was conducted in the U.S. to evaluate the safety and efficacy of Mobic. The 12-week study involved 464 patients who had osteoarthritis of the knee and hip. When three different doses of Mobic (3.5 mg, 7.5 mg, and 15 mg daily) were compared to placebo, results indicated that both the 7.5 and 15 mg daily doses of Mobic significantly decreased symptoms of pain, function, and stiffness in patients, with a low incidence of gastrointestinal side effects. Six similar studies were conducted outside of the U.S. Results were consistent with those found in the U.S. study.

Rheumatoid Arthritis

The use of Mobic for the treatment of the signs and symptoms of rheumatoid arthritis was evaluated in a 12-week, double-blind, controlled multinational trial. Mobic (7.5 mg, 15 mg, and 22.5 mg daily) was compared to placebo. The primary endpoint in this study was the ACR20 response rate, a composite measure of clinical, laboratory, and functional measures of RA response. Patients receiving Mobic 7.5 mg and 15 mg daily showed significant improvement in the primary endpoint compared with placebo. No incremental benefit was observed with the 22.5 mg dose compared to the 15 mg dose.

Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course

The use of Mobic for the treatment of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients 2 years of age and older was evaluated in two 12-week, double-blind, parallel-arm, active-controlled trials. Both studies included three arms: naproxen and two doses of meloxicam. In both studies, meloxicam dosing began at 0.125 mg/kg/day (7.5 mg maximum) or 0.25 mg/kg/day (15 mg maximum), and naproxen dosing began at 10 mg/kg/day. One study used these doses throughout the 12-week dosing period, while the other incorporated a titration after 4 weeks to doses of 0.25 mg/kg/day and 0.375 mg/kg/day (22.5 mg maximum) of meloxicam and 15 mg/kg/day of naproxen. The efficacy analysis used the ACR Pediatric 30 responder definition, a composite of parent and investigator assessments, counts of active joints and joints with limited range of motion, and erythrocyte sedimentation rate. The proportion of responders were similar in all three groups in both studies, and no difference was observed between the meloxicam dose groups.