Efficacy and safety of loxoprofen hydrogel patch versus loxoprofen tablet in patients with ankylosing spondylitis: A 4‑week randomized, open‑label study. Corrigendum in /10.3892/br.2019.1232

Fan,Meida; Cao,Shuangyan; Tu,Liudan; Wei,Qiujing; Yuan,Riwei; Li,Xuefeng; Gu,Jieruo

doi:10.3892/br.2019.1209

Efficacy and safety of loxoprofen hydrogel patch versus loxoprofen tablet in patients with ankylosing spondylitis: A 4‑week randomized, open‑label study.

Corrigendum in: /10.3892/br.2019.1232

Authors:
- Meida Fan
- Shuangyan Cao
- Liudan Tu
- Qiujing Wei
- Riwei Yuan
- Xuefeng Li
- Jieruo Gu
View Affiliations

Affiliations: Department of Rheumatology and Immunology, The Third Affiliated Hospital of Sun Yat‑Sen University, Guangzhou, Guangdong 510630, P.R. China, The Sixth Affiliated Hospital of Guangzhou Medical University, Qingyuan People's Hospital, Sino-French Hoffmann Institute, School of Basic Medical Sciences, Guangzhou Medical University, Guangzhou, Guangdong 511436, P.R. China
Published online on: May 2, 2019 https://doi.org/10.3892/br.2019.1209
Pages: 331-336

Metrics: Total Views: 0 (Spandidos Publications: | PMC Statistics: )

Metrics: Total PDF Downloads: 0 (Spandidos Publications: | PMC Statistics: )

Cited By (CrossRef): 0 citations Loading Articles...

Abstract

The aim of the present study was to assess the efficacy and safety of loxoprofen sodium hydrogel patch (LX-P) vs. loxoprofen sodium tablet (LX-T) in patients with active ankylosing spondylitis (AS). The study population consisted of patients who met the modified New York radiographic criteria for AS and had active disease. Patients were randomly assigned to either the LX-P group (LX-P 100 mg per day) or LX-T group (LX-T 60 mg 3 times daily) for 4 weeks. The primary efficacy endpoint was the percentage of patients reaching Assessment in Ankylosing Spondylitis 20% (ASAS20) response at week 4. Secondary efficacy outcomes included ASAS5/6 response rate and changes from baseline to week 4 for Ankylosing Spondylitis Disease Activity Score, patient’s global assessment of disease activity, and pain score. Of the 70 randomized patients included, 35 patients were allocated to the LX-P group and 35 to the LX-T group. No significant differences were observed between the LX-P and LX-T groups in the proportion of patients achieving ASAS20 response at week 4 (54.3 vs. 74.3%; P=0.081), nor in the ASAS5/6 response and changes of efficacy outcomes between the two groups. Furthermore, patients without peripheral arthritis in the LX-P group were more likely to achieve ASAS20 response. There was a decreased incidence of gastrointestinal adverse events in the LX-P group, but this was not significant. There was no significant differences in efficacy and safety between topical LX-P and oral LX-T administration for patients with active AS.

View Figures

View References

1	Sieper J and Poddubnyy D: Axial spondyloarthritis. Lancet. 390:73–84. 2017.PubMed/NCBI View Article : Google Scholar
2	Braun J and Sieper J: Ankylosing spondylitis. Lancet. 369:1379–1390. 2007.PubMed/NCBI View Article : Google Scholar
3	Zink A, Braun J, Listing J and Wollenhaupt J: Disability and handicap in rheumatoid arthritis and ankylosing spondylitis - results from the German rheumatological database. German Collaborative Arthritis Centers. J Rheumatol. 27:613–622. 2000.PubMed/NCBI
4	Boonen A, Chorus A, Miedema H, van der Heijde D, van der Tempel H and van der Linden S: Employment, work disability, and work days lost in patients with ankylosing spondylitis: a cross sectional study of Dutch patients. Ann Rheum Dis. 60:353–358. 2001.PubMed/NCBI View Article : Google Scholar
5	Ward MM, Deodhar A, Akl EA, Lui A, Ermann J, Gensler LS, Smith JA, Borenstein D, Hiratzka J, Weiss PF, Inman RD, et al: American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network 2015 Recommendations for the Treatment of Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis. Arthritis Care Res (Hoboken). 68:151–166. 2016.PubMed/NCBI View Article : Google Scholar
6	van der Heijde D, Ramiro S, Landewe R, Baraliakos X, Van den Bosch F, Sepriano A, Regel A, Ciurea A, Dagfinrud H, Dougados M, et al: 2016 update of the ASAS-EULAR management recommendations for axial spondyloarthritis. Ann Rheum Dis. 76:978–991. 2017.PubMed/NCBI View Article : Google Scholar
7	Wanders A, Heijde Dv, Landewé R, Béhier JM, Calin A, Olivieri I, Zeidler H and Dougados M: Nonsteroidal antiinflammatory drugs reduce radiographic progression in patients with ankylosing spondylitis: a randomized clinical trial. Arthritis Rheum. 52:1756–1765. 2005.PubMed/NCBI View Article : Google Scholar
8	Poddubnyy D, Rudwaleit M, Haibel H, Listing J, Märker-Hermann E, Zeidler H, Braun J and Sieper J: Effect of non-steroidal anti-inflammatory drugs on radiographic spinal progression in patients with axial spondyloarthritis: results from the German Spondyloarthritis Inception Cohort. Ann Rheum Dis. 71:1616–1622. 2012.PubMed/NCBI View Article : Google Scholar
9	Singh G and Triadafilopoulos G: Epidemiology of NSAID induced gastrointestinal complications. J Rheumatol Suppl. 56:18–24. 1999.PubMed/NCBI
10	Fosbøl EL, Køber L, Torp-Pedersen C and Gislason GH: Cardiovascular safety of non-steroidal anti-inflammatory drugs among healthy individuals. Expert Opin Drug Saf. 9:893–903. 2010.PubMed/NCBI View Article : Google Scholar
11	Song IH, Poddubnyy DA, Rudwaleit M and Sieper J: Benefits and risks of ankylosing spondylitis treatment with nonsteroidal antiinflammatory drugs. Arthritis Rheum. 58:929–938. 2008.PubMed/NCBI View Article : Google Scholar
12	Shau WY, Chen HC, Chen ST, Chou HW, Chang CH, Kuo CW and Lai MS: Risk of new acute myocardial infarction hospitalization associated with use of oral and parenteral non-steroidal anti-inflammation drugs (NSAIDs): a case-crossover study of Taiwan's National Health Insurance claims database and review of current evidence. BMC Cardiovasc Disord. 12(4)2012.PubMed/NCBI View Article : Google Scholar
13	Shukla A, Rai MK, Prasad N and Agarwal V: Short-Term Non-Steroid Anti-Inflammatory Drug Use in Spondyloarthritis Patients Induces Subclinical Acute Kidney Injury: Biomarkers Study. Nephron. 135:277–286. 2017.PubMed/NCBI View Article : Google Scholar
14	Massey T, Derry S, Moore RA and McQuay HJ: Topical NSAIDs for acute pain in adults. Cochrane Database Syst Rev. 6(CD007402)2010.PubMed/NCBI View Article : Google Scholar
15	Derry S, Moore RA and Rabbie R: Topical NSAIDs for chronic musculoskeletal pain in adults. Cochrane Database Syst Rev. 9(CD007400)2012.PubMed/NCBI View Article : Google Scholar
16	Mu R, Bao CD, Chen ZW, Zheng Y, Wang GC, Zhao DB, Hu SX, Li YJ, Shao ZW, Zhang ZY, et al: Efficacy and safety of loxoprofen hydrogel patch versus loxoprofen tablet in patients with knee osteoarthritis: a randomized controlled non-inferiority trial. Clin Rheumatol. 35:165–173. 2016.PubMed/NCBI View Article : Google Scholar
17	van der Linden S, Valkenburg HA and Cats A: Evaluation of diagnostic criteria for ankylosing spondylitis. A proposal for modification of the New York criteria. Arthritis Rheum. 27:361–368. 1984.PubMed/NCBI View Article : Google Scholar
18	Garrett S, Jenkinson T, Kennedy LG, Whitelock H, Gaisford P and Calin A: A new approach to defining disease status in ankylosing spondylitis: the Bath Ankylosing Spondylitis Disease Activity Index. J Rheumatol. 21:2286–2291. 1994.PubMed/NCBI
19	van der Heijde D, Lie E, Kvien TK, Sieper J, Van den Bosch F, Listing J, Braun J and Landewé R; Assessment of SpondyloArthritis international Society (ASAS): ASDAS, a highly discriminatory ASAS-endorsed disease activity score in patients with ankylosing spondylitis. Ann Rheum Dis. 68:1811–1818. 2009.PubMed/NCBI View Article : Google Scholar
20	Machado P, Landewé R, Lie E, Kvien TK, Braun J, Baker D and van der Heijde D; Assessment of SpondyloArthritis international Society: Ankylosing Spondylitis Disease Activity Score (ASDAS): defining cut-off values for disease activity states and improvement scores. Ann Rheum Dis. 70:47–53. 2011.PubMed/NCBI View Article : Google Scholar
21	Grimes DA, Hubacher D, Nanda K, Schulz KF, Moher D and Altman DG: The Good Clinical Practice guideline: a bronze standard for clinical research. Lancet. 366:172–174. 2005.PubMed/NCBI View Article : Google Scholar
22	Anderson JJ, Baron G, van der Heijde D, Felson DT and Dougados M: Ankylosing spondylitis assessment group preliminary definition of short-term improvement in ankylosing spondylitis. Arthritis Rheum. 44:1876–1886. 2001.PubMed/NCBI View Article : Google Scholar
23	Calin A, Garrett S, Whitelock H, Kennedy LG, O'Hea J, Mallorie P and Jenkinson T: A new approach to defining functional ability in ankylosing spondylitis: the development of the Bath Ankylosing Spondylitis Functional Index. J Rheumatol. 21:2281–2285. 1994.PubMed/NCBI
24	Banning M: The use of topical diclofenac for pain in osteoarthritis of the knee: a review. Br J Community Nurs. 11:487–492. 2006.PubMed/NCBI
25	Tugwell PS, Wells GA and Shainhouse JZ: Equivalence study of a topical diclofenac solution (pennsaid) compared with oral diclofenac in symptomatic treatment of osteoarthritis of the knee: a randomized controlled trial. J Rheumatol. 31:2002–2012. 2004.PubMed/NCBI