Evaluation of the short-term efficacy of NSAIDs on patients with active ankylosing spondylitis in daily practice: A 3-month, longitudinal, observational study
Rheumatology International, cilt.30, sa.3, ss.331-340, 2010 (SCI-Expanded, Scopus)
- Yayın Türü: Makale / Tam Makale
- Cilt numarası: 30 Sayı: 3
- Basım Tarihi: 2010
- Doi Numarası: 10.1007/s00296-009-0963-y
- Dergi Adı: Rheumatology International
- Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus
- Sayfa Sayıları: ss.331-340
- Anahtar Kelimeler: Ankylosing spondylitis, Non-steroidal anti-inflammatory drugs, Therapy
- Sağlık Bilimleri Üniversitesi Adresli: Evet
Özet
The objective of the study was to investigate the response rate to non-steroidal anti-inflammatory drugs (NSAIDs) and the clinical parameters that might predict this response in patients with active ankylosing spondylitis. This is a prospective, observational, 3-month study that was conducted in a single center. Ninety-five consecutive patients with active ankylosing spondylitis were included in the study. Full dose NSAIDs (indometacin 150 mg daily or acemethazine 180 mg daily) were given to patients. Relevant clinical data of all patients' were recorded at the beginning and on three consecutive monthly visits. At the end of the study period, patients who respond to NSAIDs were determined. Demographic, clinical, and laboratory parameters that might influence the response to the NSAIDs were investigated. The response rate to the full-dose NSAIDs according to the ASAS20 in patients with active ankylosing spondylitis was found as 29.5%. Similarly, 20.0% of the patients were responders according to the ASAS40 criteria, whereas 5.6% of the patients responded according to the 5-out-of-6 criteria at week 12. Patients who responded to the treatment were found to be younger at the study entry (P = 0.001) and had shorter disease duration (P < 0.001). Due to the markedly lower rate of response to the NSAIDs in patients with active ankylosing spondylitis, early identification of those patients who does not respond to NSAIDs and subsequent decision regarding the institution of second-line treatments (anti-TNF) may be of great value in the prevention of irreversible changes that might develop in most of the patients. © 2009 Springer-Verlag. TypeofStudy:An open, longitudinal, observational, single-center study evaluating the rate of response and safety of nonsteroidal antiinflammatory drugs (NSAIDs; including Voltaren, indometacin, acemetazine, flurbiprofen, and celecoxib) in patients with active ankylosing spondylitis (AS). Indications:10 patients with refractory active ankylosing spondylitis. Coexisting diseases: psoriasis, urethritis, and diarrhea in an unspecified number of patients. Patients:95 outpatients, 83 males and 12 females, mean age 28.9 years, 47 treatment naive and 48 were on NSAIDs on demand only for the last 3 months. Initial NSAIDs consisted of indometacin (n=80) or acemetazine (n=15) and patients who did not respond or were intolerant at 1st week were switched to Voltaren (n=10), flurbiprofen (n=4), or celecoxib (n=1). 66 remained on indometacin and 14 on acemetazine. Follow-up: 3 months. DosageDuration:150 mg daily bid. Duration: 3 months. ComparativeDrug:Indometacin dose was 150 mg daily tid, acemetazine 180 mg daily bid, flurbiprofen 200 mg daily bid, and celecoxib dose not stated. Duration: 3 months. Results:At week 12, the overall response rate to NSAIDs according to the ASAS20 was 29.5%, ASAS40 was 20.0%, and ASAS5/6 was 5.6%. No significant differences were noted between NSAID naive and on demand groups regarding ASAS20 and ASAS40 responses. Significant improvement was noted in BASDAI, BAS-G, morning stiffness, pain, fatigue, and tender joint count at week 12 as compared with median values at baseline. Lumber side flexion, modified Schober, intermalleolar distance, degree of cervical rotation, chest expansion, swollen joint count, MASES, BASMI, and BASFI values showed remarkable improvements. The mean ESR values reduced from 32.2 to 22.0 mm/hour, and CRP levels reduced from 25.9 to 21.9 mg/L at week 12. Patients who responded to the treatment were found to be younger, and had shorter disease duration as compared to the non-responders. Indometacin was given to 30.3% of patients, acemethazine to 28.6%, and other NSAIDs (Voltaren, flurbiprophene, and celecoxib) to 26.7% who responded to the treatment. There was no remarkable difference between the particular NSAIDs with respect to the response. Adverse events that were possibly drug related reported to be mild to moderate. At the end of the trial, none of the patients withdrew treatment due to an adverse event. Headache (12.6%) and dyspepsia (10.5%) were the most common adverse events reported. At week 12, AST increased in 14 (14.7%) and ALT increased in 7 (7.4%) patients as compared to baseline. The increase of AST and ALT levels was remarkable. High blood pressure in 4 (4.2%) patients and proteinuria in 2 (2.1%) patients were developed. AdverseEffects:Unspecified number of patients had headache, dyspepsia, increased aspartate aminotransferase and alanine aminotransferase, high blood pressure, and proteinuria. AuthorsConclusions:In conclusion, we suggest that, due to the markedly lower rate of response to the NSAIDs in patients with active AS, early identification of those patients who does not respond to NSAIDs and subsequent decision regarding the institution of anti-TNF [tumor necrosis factor] treatment may be of great value in the prevention of irreversible changes that might develop in most of the patients. FreeText:Outcome measures: disease status by Bath ankylosing spondylitis disease activity index (BASDAI), function (Bath AS functional index; BASFI), and metrology (Bath AS metrology index; BASMI); global disease assessment by the Bath AS patient global score (BAS-G) on a 100-mm visual analog scale (VAS); response to treatment was determined according to the Assessment in Ankylosing Spondylitis (ASAS) International Working Group criteria (ASAS20 response requires improvement of at least 20% and absolute improvement of at least 10 units in 3 of the following 4 domains: patient's global assessment of the disease activity during the previous week, pain, function, and inflammation, ASAS40 and ASAS 5/6 response); enthesitis by Maastricht AS enthesitis score (MASES); erythrocyte sedimentation rate (ESR), C-reactive protein levels (CRP); musculoskeletal assessments (swollen joint count, tender joint count and chest expansion); and safety tests (aspartate and alanine aminotransferases, hemoglobin, blood pressure, and proteinuria). Concomitant drug: omeprazole 20 mg daily in all patients.