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Celecoxib for the Treatment of Ankylosing Spondylitis

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Celecoxib for the Treatment of Ankylosing Spondylitis www.symbiosisonline.org Symbiosis www.symbiosisonlinepublishing.com Mini Review Article Journal of Rheumatology and Arthritic Diseases Open Access Celecoxib for the Treatment of Ankylosing Spondylitis Jian Zhu1, Cindi Sounthonevat2*, Chris Walker3 1Department of Rheumatology, Chinese PLA General Hospital, Beijing, China. 2Rutgers Post-Doctoral Fellow at Pfizer, New York, NY, USA. 3Pfizer Ltd, Walton Oaks, UK Received: January 3, 2017; Accepted: February 2, 2017; Published: March 6, 2017 *Corresponding author: Cindi Sounthonevat. Rutgers Post-Doctoral Fellow at Pfizer Ltd, New York, NY, USA. Email: [email protected] of the more extensively studied NSAID treatments for ankylosing Abstract spondylitis. Finally, the potential disease modifying properties of Ankylosing spondylitis is a debilitating form of chronic celecoxib are discussed. is based on non-pharmacological therapy, largely exercise, and Inflammation Is A Key Component Of Ankylosing inflammatory arthritis which primarily affects the spine. Treatment Spondylitis wellpharmacological studied pharmacological therapy, with treatments non-steroidal for patients anti-inflammatory with ankylosing spondylitisdrugs (NSAIDs) is recommendedthe cyclooxygenase-2 as first-line selective treatment. NSAID One ofcelecoxib. the most pain, caused by sacroiliitis and spondylitis, which can lead to boneAnkylosing fusion of spondylitisissacroiliac joints, characterized vertebral byfacet inflammatory joints and interback pathology of the disease. Data from randomized, controlled clinical vertebral discs and a resulting spinal stiffness and loss of mobility trialsThis short of celecoxib review in highlights patients withthe importance ankylosing spondylitisof inflammation is reviewed in the from longer-term trials suggest that celecoxib may have disease [1]. Chronic inflammation likely leads directly to the stiffness and modifyingwith respect properties. to efficacy In addition, and safety. more In recent addition, data more from longer-termrecent data process may prevent ongoing structural damage [6]. trials suggest that celecoxib may have disease modifying properties, bone fusion, and control of inflammation early in the disease Celecoxib Is An Effective Treatment Option For Patients With Ankylosing Spondylitis with the benefits perhaps being more pronounced in patients with syndesmophytes and elevated inflammation levels indicative of more Guidelines indicativesevere disease. of more With severe the disease.benefits perhaps being more pronounced in patients with syndesmophytes and elevated inflammation levels Keywords: Ankylosing spondylitis; Celecoxib; Disease guidelines [5] advise that treatment should be tailored according to theThe current European manifestations League Againstof the disease,Rheumatism including (EULAR) status and severity of symptoms. Disease monitoring (on an individual modification Introduction basis) should include patient history, clinical parameters, laboratory tests, and imaging, while non-pharmacological treatment should be based on patient education and regular exercise [5]. ankylosingAnkylosing spondylitis spondylitis is thought is a form to be ofbetween chronic 0·1% inflammatory and 1·4% arthritis primarily affecting the spine [1]. The prevalence of [1]. It is a disease of young people, generally presenting around with other pharmacologicalOngoing treatment treatments with NSAIDs, (including including analgesics, COX-2 26 years of age, [2] and being more common in men than women directedselective corticosteroidinhibitors, is recommended injections, and as anti-tumor first-line drug necrosis treatment factor with one study reporting a ratio of males to females of 2.4:1 [3]. may also be considered in more severe, non-responding patients [TNF] therapy) considered if NSAIDs are ineffective [5]. Surgery Treatment aims to reduce symptoms, maintain flexibility and [5]. physicalposture, andtherapy/exercise retard structural in damagecombination [4, 5]. Therewith non-steroidalis no cure but European and North American treatment guidelines recommend [4] are similar, also strongly recommending ongoing treatment The American College of Rheumatology (ACR) guidelines- anti-inflammatory drugs (NSAIDs), including COX-2 selective strongly recommended in patients who do not inhibitors as first-line treatment [4, 5]. respondwith NSAIDs to NSAIDs and physical as is surgery therapy. for Inmore the severeACR guidelines, patients, while anti ankylosing spondylitis and reviews the available data on the TNF therapy is This publication outlines the key role of inflammation in the guidelines strongly recommended against the use of systemic safety and efficacy of the COX-2 selective inhibitor celecoxib, one Symbiosis Group *Corresponding author email: [email protected] Celecoxib for the Treatment of Ankylosing Spondylitis Copyright: © 2017 Sounthonevat, et al. glucocorticoids [4]. naproxen at 500 mg twice daily [16]. At 6 weeks, mean change in pain score was -12.6 with placebo compared with -33.7 with Clinical data naproxen, and -41.5 and -41.6 with etoricoxib 90 mg and 120 mg, respectively and this improvement was maintained over celecoxib for the treatment of ankylosing spondylitis (Table 1 There have been five randomized, controlled trials of dose of etoricoxib was initially limited to 90 mg/day by health outcomes compared with placebo and non-inferiority compared authorities,the 1 year active-comparatorhowever recent regulatory phase [16]. activity The recommendedhas led to a ) [7-11]. The trials demonstrated both significantly improved reduction in the initial dose of etoricoxib recommended for during active treatment; although, in one trial, one patient died ankylosing spondylitis in some countries [17]. A starting dose with non-selective NSAIDs. There were no reported deaths of 60 mg/day is now recommended, with the caveat that some seriousfollowing adverse discontinuation events with of celecoxib celecoxib included due to severe lack ofdecreased efficacy labeling further recommends a potential return to 60 mg/day in bloodbut this pressure, was considered severe renal unrelated calculus, to angina treatment pectoris, [8]. dyspnoea,Reported patients oncemay benefitthey are from clinically increasing stabilized the dose [18]. to 90 mg/day. The sudden hearing loss, deterioration of ankylosing spondylitis, Disease Modification In Ankylosing Spondylitis and familial Mediterranean fever but overall incidence was comparable with controls [7-11]. of typical disease-modifying anti-rheumatic drugs (such as sulfasalazineThere is noand cure methotrexate) for ankylosing has spondylitisnot been shownand the to usebe typically associated with numerically fewer gastrointestinal effective [1,5]. Initially, NSAIDs were considered to only modify Overall, celecoxib was well tolerated in these trials and was adverse events than the non-selective NSAID comparators [7-11], the symptoms of ankylosing spondylitis with no effect on consistent with the established superior gastrointestinal safety the progression of disease. However, long-term follow-up of patients from one randomized controlled trial of celecoxib [7] difference in cardiovascular adverse events in the trials, although demonstrated that continuous treatment with celecoxib (for of COX-2 selective inhibitors [12]. There was also no notable the trials were of limited duration and in relatively young 2 years) resulted in a reduction in radiological progression patients (Table 1 when compared with patients receiving treatment on demand fewer comorbidities than the majority of other patients treated ) [13]. Being significantly younger and with with celecoxib, ankylosing spondylitis patients would likely be at modifying properties in addition to the relief of symptoms. A lower risk of gastrointestinal and cardiovascular complications similar[19]. This reduction reduction in suggestedradiological that progression NSAIDs may was have shown disease in [13]. Nevertheless, currently available data from patients with patients with a high intake of NSAIDs over 2 years, with the effect osteoarthritis and rheumatoid arthritis supports the view that being most pronounced in patients with elevated C reactive celecoxib is not associated with an increased cardiovascular risk when compared with non-selective NSAIDs such as ibuprofen more severe disease and treatment with NSAIDs has been shown and naproxen [14, 15]. protein (CRP) [20]. Increased levels of CRP are associated with to reduce levels of CRP [21]. been examined in a 52 week randomized, controlled trial [16]. this process with continuous NSAID treatment leading to a more An alternative COX-2 selective inhibitor, etoricoxib, has also pronouncedOther acute slowing phase of radiographicreactants have progression also been in implicated patients with in week active-comparator controlled period in which etoricoxib atThis 90 trial or included120 mg oncea 6 week daily placebo was compared controlled with period placebo and a and46- elevated erythrocyte sedimentation rate (ESR), high Ankylosing spondylitis disease activity score (ASDAS)-CRP, or high ASDAS- Table 1: Celecoxib Comparator(s) Efficacy outcomes in clinicalMean trials age, of celecoxib in patients with ankylosing spondylitis Patients Duration Study range Mean change Mean change (N) (weeks) (years) Dose N in pain Dose n in pain intensity intensity Ketoprofen 100 mg qd 90 -21 Dougados, 2001 [8] 246 38-40 6 Celecoxib 100 mg qd 80 -27 Placebo 76 -13 Celecoxib 200 mg qd 137 -30.0 Naproxen 500 mg bid 157 -36.3 Barkhuizen,
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