Pfizer Limited announced today that Celebrex © (celecoxib) is the first oral selective COX-2 inhibitor that has been granted the label extension for “symptomatic relief in the treatment of Ankylosing Spondylitis” in the UK due to the positive outcome of the European mutual recognition process (MRP), involving 17 European countries1.
Ankylosing Spondylitis (AS) is a chronic, inflammatory rheumatic disease, mainly affecting younger males and most commonly starting in the stage of late adolescence2. With its early onset and progressive joint damage, AS imposes a significant burden on both patients and payers3. The estimated UK prevalence of AS is between 0.05 – 0.23%4.
Celebrex has been extensively tested on AS patients. Nearly 900 patients were included in placebo and active controlled trials of up to 12 weeks duration; in these trials Celebrex demonstrated a significant improvement in pain, global disease activity and function for patients suffering AS versus placebo.8, 9,10,11,12 Additionally, Celebrex offers similar pain relief to the commonly used traditional non-steroidal anti-inflammatory drug (t-NSAID) diclofenac10,11.
Sweden, acting as reference member state, positively completed the Mutual Recognition Variation procedure which has extended Celebrex indications to: symptomatic treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.
Dr Marwan Bukhari, Consultant Rheumatologist, Royal Lancaster Infirmary added: “This is good news for AS patients who suffer prolonged periods of severe pain because of the high inflammatory component of the disease. Celebrex is a non-steroidal anti-inflammatory drug (NSAID) that offers relief of the pain and inflammation for appropriately- selected patients, taking into account the gastrointestinal and cardiovascular risk benefit profile in accordance with EMEA guidance* and the Summary of Product Characteristics.”
John Young, Managing Director of Pfizer Limited said: “We are delighted that the European Regulators including the MHRA have recognised that Celebrex is an effective and generally well tolerated treatment particularly suited to the needs of eligible AS patients according to EMEA guidance* and the Summary of Product Characteristics. Celebrex is one of the most extensively studied COX-2s – trial data from 34,000 patients offers a large body of evidence to support the risk-benefit profile of this anti-inflammatory medicine.13 It has been proven that in OA and RA, Celebrex offers appropriate patients effective symptomatic pain relief with significantly fewer serious gastrointestinal complications than traditional NSAIDs**.14,15,16,17,18,19,20,21,22 ”
In clinical trials, Celebrex was generally well tolerated with overall discontinuation rates due to side effects similar to those of placebo (7.1 % for celecoxib vs. 6.1 % for placebo).23 Commonly observed side effects (≥1/100, <1/10) were sinusitis, upper respiratory tract infection, insomnia, dizziness, pharyngitis, rhinitis, abdominal pain, diarrhoea, dyspepsia, flatulence, rash and peripheral oedema/fluid retention.
Celebrex is available in 100 and 200 mg capsules. The usual recommended daily dose for symptomatic relief in the treatment of Ankylosing Spondylitis is 200 mg taken once daily or in two divided doses. In some patients, with insufficient relief from symptoms, an increased dose of 400 mg once daily or in two divided doses may increase efficacy. In the absence of an increase in therapeutic benefit after two weeks, other therapeutic options should be considered.
In 2005, the EMEA issued guidance which concluded that the balance of benefits and risks remains positive for the COX-2 inhibitors used in their target patient populations when prescribed in accordance with the additional cardiovascular contraindications and precautions.24
In Europe the MRP for Celebrex for the symptomatic treatment of osteoarthritis and rheumatoid arthritis was concluded in March 2000 following first approval in Sweden in December 1999. Celebrex was granted U.S. Food and Drug Administration approval for the indication ankylosing spondylitis in July 2005.