Briefing Note: ketoprofen / omeprazole (Axorid)

SMC did not recommend ketoprofen/omeprazole for the symptomatic treatment of rheumatoid arthritis, ankylosing spondylitis and osteoarthritis in patients with a previous history or who are at risk of developing nonsteroidal anti-inflammatory drug (NSAID)-associated gastric ulcers, duodenal ulcers and gastroduodenal erosions in whom continued treatment with ketoprofen is essential.

• Rheumatoid arthritis, ankylosing spondylitis and osteoarthritis are conditions affecting joints and the surrounding soft tissues. Rheumatoid arthritis is a chronic condition in which the immune system attacks the lining of the joints, causing them to become inflamed and stop working properly. Ankylosing spondylitis is the persistent inflammation of the spine and sacroiliac joints (joints that lie at the junction of the spine and the pelvis) in the pelvis eventually causing fusion of the spine. Osteoarthritis is a condition characterised by the breakdown of the cartilage (the smooth surface that lines the bones and allows joints to move easily) of the joint. Symptoms for these rheumatic disorders vary, ranging from mild discomfort to progressively debilitating which interferes with movement and daily activities.
• Treatment for these rheumatic conditions include NSAIDs (such as aspirin and ibuprofen) to reduce symptoms of inflammation, relieve pain and swelling. A serious unwanted effect of NSAIDs is the increased risk of ulcers developing in the gastrointestinal tract due to length of their use and high doses. Axorid® is a new product containing a prolonged-release form of the NSAID ketoprofen in combination with a proton pump inhibitor omeprazole, which reduces the amount of acid produced in the stomach. This new formulation reduces the risk of NSAID side effects of NSAIDs on the stomach and duodenum in patients already suffering from ulcers that need continuous anti-inflammatory treatment. Ketoprofen/omeprazole is taken as a tablet once daily depending on symptoms.

• No clinical efficacy and safety studies were deemed necessary as ketoprofen and omeprazole are already approved for their respective indications. Several studies in healthy volunteers showed the bioequivalence of this combination product to the reference products.
• SMC did not accept ketoprofen/omeprazole for use because a number of weaknesses in the economic case submitted by the manufacturer meant that value for money was not demonstrated. The key weakness was the manufacturer’s use of an inappropriate comparator.