Assessment of the Anti-inflammatory Effects of NORFLO® ORO in Acute Relapses of HLA-B27-associated Autoimmune Uveitis: A Multicenter, Randomized, Placebo-controlled, Double-blind Clinical Study

References

• Wakefield D, Clarke D, McCluskey P. Recent developments in HLA B27 anterior uveitis. Front Immunol. 2021;11:608134. doi:10.3389/fimmu.2020.608134.
   PubMed Web of Science ®Google Scholar
• Rademacher J, Poddubnyy D, Pleyer U. Uveitis in spondyloarthritis. Ther Adv Musculoskelet Dis. 2020;12:1759720X20951733. doi:10.1177/1759720X20951733.
   PubMed Web of Science ®Google Scholar
• Chang JH, McCluskey PJ, Wakefield D. Acute anterior uveitis and HLA-B27. Surv Ophthalmol. 2005;50(4):364–388. doi:10.1016/j.survophthal.2005.04.003.
   PubMed Web of Science ®Google Scholar
• Pathanapitoon K, Dodds EM, Cunningham ET Jr, Rothova A. Clinical spectrum of HLA-B27-associated ocular inflammation. Ocul Immunol Inflamm. 2017;25(4):569–576. doi:10.1080/09273948.2016.1185527.
   PubMed Web of Science ®Google Scholar
• Bacchiega ABS, Balbi GGM, Ochtrop MLG, de Andrade FA, Levy RA, Baraliakos X. Ocular involvement in patients with spondyloarthritis. Rheumatology (Oxford). 2017;56(12):2060–2067. doi:10.1093/rheumatology/kex057.
   PubMed Web of Science ®Google Scholar
• D’Ambrosio EM, La Cava M, Tortorella P, Gharbiya M, Campanella M, Iannetti L. Clinical features and complications of the HLA-B27-associated acute anterior uveitis: a metanalysis. Semin Ophthalmol. 2017;32(6):689–701. doi:10.3109/08820538.2016.1170158.
   PubMed Web of Science ®Google Scholar
• Standardization of Uveitis Nomenclature (SUN) Working Group; Jabs DA, Acharya NR, Chee SP, et al. Classification criteria for spondyloarthritis/HLA-B27-associated anterior uveitis. Am J Ophthalmol. 2021: S0002-9394(21)00174-4. doi:10.1016/j.ajo.2021.03.049.
   PubMedGoogle Scholar
• Rathinam SR, Tugal-Tutkun I, Agarwal M, Rajesh V, Egriparmak M, Patnaik G. Immunological tests and their interpretation in uveitis. Indian J Ophthalmol. 2020;68(9):1737–1748. doi:10.4103/ijo.IJO_570_20.
   PubMed Web of Science ®Google Scholar
• Juanola X, Loza Santamaría E, Cordero-Coma M; SENTINEL Working Group. Description and prevalence of spondyloarthritis in patients with anterior uveitis: the SENTINEL interdisciplinary collaborative project. Ophthalmology. 2016;123(8):1632–1636. doi:10.1016/j.ophtha.2016.03.010.
   PubMed Web of Science ®Google Scholar
• Haroon M, O’Rourke M, Ramasamy P, Murphy CC, FitzGerald O. A novel evidence-based detection of undiagnosed spondyloarthritis in patients presenting with acute anterior uveitis: the DUET (Dublin Uveitis Evaluation Tool). Ann Rheum Dis. 2015;74(11):1990–1995. doi:10.1136/annrheumdis-2014-205358.
   PubMed Web of Science ®Google Scholar
• Choi RY, Asquith M, Rosenbaum JT. Fecal transplants in spondyloarthritis and uveitis: ready for a clinical trial? Curr Opin Rheumatol. 2018;30(4):303–309. doi:10.1097/BOR.0000000000000506.
   PubMed Web of Science ®Google Scholar
• The effect of fecal microbiota transplantation in Ankylosing spondylitis (AS) patients. (ASGUT) ClinicalTrials.gov Identifier: NCT03726645
   Google Scholar
• Salehi B, Stojanović-Radić Z, Matejić J, et al. The therapeutic potential of curcumin: a review of clinical trials. Eur J Med Chem. 2019;163:527–545. doi:10.1016/j.ejmech.2018.12.016.
   PubMed Web of Science ®Google Scholar
• Aggarwal BB, Harikumar KB. Potential therapeutic effects of curcumin, the anti-inflammatory agent, against neurodegenerative, cardiovascular, pulmonary, metabolic, autoimmune and neoplastic diseases. Int J Biochem Cell Biol. 2009;41(1):40–59. doi:10.1016/j.biocel.2008.06.010.
   PubMed Web of Science ®Google Scholar
• Agnihotri N, Mishra PC. Scavenging mechanism of curcumin toward the hydroxyl radical: a theoretical study of reactions producing ferulic acid and vanillin. J Phys Chem A. 2011;115(49):14221–14232. doi:10.1021/jp209318f.
   PubMed Web of Science ®Google Scholar
• Chainani-Wu N. Safety and anti-inflammatory activity of curcumin: a component of tumeric (Curcuma longa). J Altern Complement Med. 2003;9(1):161–168. doi:10.1089/107555303321223035.
   PubMed Web of Science ®Google Scholar
• Anand P, Kunnumakkara AB, Newman RA, Aggarwal BB. Bioavailability of curcumin: problems and promises. Mol Pharm. 2007;4:807–818. doi:10.1021/mp700113r.
   PubMed Web of Science ®Google Scholar
• Gupta NK, Dixit VK. Bioavailability enhancement of curcumin by complexation with phosphatidyl choline. J Pharm Sci. 2011;100(5):1987–1995. doi:10.1002/jps.22393.
   PubMed Web of Science ®Google Scholar
• Kidd PM. Bioavailability and activity of phytosome complexes from botanical polyphenols: the silymarin, curcumin, green tea, and grape seed extracts. Altern Med Rev. 2009;14:226–246.
   PubMed Web of Science ®Google Scholar
• Muangnoi C, Sharif U, Ratnatilaka Na Bhuket P, Rojsitthisak P, Paraoan L. Protective effects of curcumin ester prodrug, curcumin diethyl disuccinate against H2O2-induced oxidative stress in human retinal pigment epithelial cells: potential therapeutic avenues for age-related macular degeneration. Int J Mol Sci. 2019;20:3367. doi:10.3390/ijms20133367.
   PubMed Web of Science ®Google Scholar
• Wang LL, Sun Y, Huang K, Zheng L. Curcumin, a potential therapeutic candidate for retinal diseases. Mol Nutr Food Res. 2013;57(9):1557–1568. doi:10.1002/mnfr.201200718.
   PubMed Web of Science ®Google Scholar
• Peddada KV, Brown A, Verma V, Nebbioso M. Therapeutic potential of curcumin in major retinal pathologies. Int Ophthalmol. 2019;39(3):725–734. doi:10.1007/s10792-018-0845-y.
   PubMed Web of Science ®Google Scholar
• López-Malo D, Villarón-Casares CA, Alarcón-Jiménez J, et al. Curcumin as a therapeutic option in retinal diseases. Antioxidants (Basel). 2020;9(1):48. doi:10.3390/antiox9010048.
   PubMedGoogle Scholar
• Mazzolani F, Togni S. Oral administration of a curcumin-phosholipid delivery system for the treatment of central serous chorioretinopathy: a 12-month follow-up study. Clin Ophthalmol. 2013;7:939–945. doi:10.2147/OPTH.S45820.
   PubMedGoogle Scholar
• Pescosolido N, Giannotti R, Plateroti AM, Pascarella A, Nebbioso M. Curcumin: therapeutical potential in ophthalmology. Planta Med. 2014;80(4):249–254. doi:10.1055/s-0033-1351074.
   PubMed Web of Science ®Google Scholar
• Jabs DA, Nussenblatt RB, Rosenbaum JT; Standardization of Uveitis Nomenclature (SUN) Working Group. Standardization of uveitis nomenclature for reporting clinical data. Results of the first international workshop. Am J Ophthalmol. 2005;140(3):509–516. doi:10.1016/j.ajo.2005.03.057.
   PubMed Web of Science ®Google Scholar
• de Boer AG, van Lanschot JJ, Stalmeier PF, et al. Is a single-item visual analogue scale as valid, reliable and responsive as multi-item scales in measuring quality of life? Qual Life Res. 2004;13(2):311–320. doi:10.1023/B:QURE.0000018499.64574.1f.
   PubMed Web of Science ®Google Scholar
• Berzon RA. Understanding and using health-related quality of life instruments within clinical research studies. In: Staquet MJ, Hays RD, Fayers PM, eds. Quality of Life Assessment in Clinical Trials. Oxford: Oxford University Press; 1998.
   Google Scholar
• IQVIA treatment satisfaction questionnaire for medication (TSQM)©. https://www.iqvia.com/landing/treatment-satisfaction-questionnaire-for-medication-tsqm.
   Google Scholar
• Treatment perceptions questionnaire by the European Monitoring Centre for drugs and drugs addition. https://www.emcdda.europa.eu/drugs-library/treatment-perceptions-questionnaire_en.
   Google Scholar
• Sharip A, Kunz J. Understanding the Pathogenesis of Spondyloarthritis. Biomolecules. 2020;10(10):1461. doi:10.3390/biom10101461.
   PubMed Web of Science ®Google Scholar
• Monnet D, Breban M, Hudry C, Dougados M, Brézin AP. Ophthalmic findings and frequency of extraocular manifestations in patients with HLA-B27 uveitis: a study of 175 cases. Ophthalmology. 2004;111(4):802–809. doi:10.1016/j.ophtha.2003.07.011.
   PubMed Web of Science ®Google Scholar
• Accorinti M, Iannetti L, Liverani M, Caggiano C, Gilardi M. Clinical features and prognosis of HLA B27-associated acute anterior uveitis in an Italian patient population. Ocul Immunol Inflamm. 2010;18(2):91–96. doi:10.3109/09273941003597268.
   PubMed Web of Science ®Google Scholar
• Power WJ, Rodriguez A, Pedroza-Seres M, Foster CS. Outcomes in anterior uveitis associated with the HLA-B27 haplotype. Ophthalmology. 1998;105:1646–1651. doi:10.1016/S0161-6420(98)99033-9.
   PubMed Web of Science ®Google Scholar
• Agnani S, Choi D, Martin TM, et al. Gender and laterality affect recurrences of acute anterior uveitis. Br J Ophthalmol. 2010;94(12):1643–1647. doi:10.1136/bjo.2009.172312.
   PubMed Web of Science ®Google Scholar
• Loh AR, Acharya NR. Incidence rates and risk factors for ocular complications and vision loss in HLA-B27-associated uveitis. Am J Ophthalmol. 2010;150(4):534–542.e2. doi:10.1016/j.ajo.2010.04.031.
   PubMed Web of Science ®Google Scholar
• Hoeksema L, Los LI. Vision-related quality of life in patients with inactive HLA-B27-associated-spectrum anterior uveitis. PLoS One. 2016;11(1):e0146956. doi:10.1371/journal.pone.0146956.
   PubMed Web of Science ®Google Scholar
• Fiorelli VM, Bhat P, Foster CS. Nonsteroidal anti-inflammatory therapy and recurrent acute anterior uveitis. Ocul Immunol Inflamm. 2010;18(2):116–120. doi:10.3109/09273941003587558.
   PubMed Web of Science ®Google Scholar
• Muñoz-Fernández S, Hidalgo V, Fernández-Melón J, et al. Sulfasalazine reduces the number of flares of acute anterior uveitis over a one-year period. J Rheumatol. 2003;30:1277–1279.
   PubMed Web of Science ®Google Scholar
• Muñoz-Fernández S, García-Aparicio AM, Hidalgo MV, et al. Methotrexate: an option for preventing the recurrence of acute anterior uveitis. Eye (Lond). 2009;23(5):1130–1133. doi:10.1038/eye.2008.198.
   PubMed Web of Science ®Google Scholar
• Braun J, Baraliakos X, Listing J, Sieper J. Decreased incidence of anterior uveitis in patients with ankylosing spondylitis treated with the anti-tumor necrosis factor agents infliximab and etanercept. Arthritis Rheum. 2005;52(8):2447–2451. doi:10.1002/art.21197.
   PubMed Web of Science ®Google Scholar
• Rudwaleit M, Rødevand E, Holck P, et al. Adalimumab effectively reduces the rate of anterior uveitis flares in patients with active ankylosing spondylitis: results of a prospective open-label study. Ann Rheum Dis. 2009;68(5):696–701. doi:10.1136/ard.2008.092585.
   PubMed Web of Science ®Google Scholar
• van der Horst-bruinsma IE, van Bentum RE, Verbraak FD, et al. Reduction of anterior uveitis flares in patients with axial spondyloarthritis on certolizumab pegol treatment: final 2-year results from the multicenter phase IV C-VIEW study. Ther Adv Musculoskelet Dis. 2021;13:1759720X211003803. doi:10.1177/1759720X211003803.
   PubMed Web of Science ®Google Scholar
• Prasad S, Tyagi AK, Aggarwal BB. Recent developments in delivery, bioavailability, absorption and metabolism of curcumin: the golden pigment from golden spice. Cancer Res Treat. 2014;46(1):2–18. doi:10.4143/crt.2014.46.1.2.
   PubMed Web of Science ®Google Scholar
• Sanidad KZ, Sukamtoh E, Xiao H, McClements DJ, Zhang G. Curcumin: recent advances in the development of strategies to improve oral bioavailability. Annu Rev Food Sci Technol. 2019;10:597–617. doi:10.1146/annurev-food-032818-121738.
   PubMed Web of Science ®Google Scholar
• Jäger R, Lowery RP, Calvanese AV, Joy JM, Purpura M, Wilson JM. Comparative absorption of curcumin formulations. Nutr J. 2014;13:11. doi:10.1186/1475-2891-13-11.
   PubMed Web of Science ®Google Scholar
• Tsuda T. Curcumin as a functional food-derived factor: degradation products, metabolites, bioactivity, and future perspectives. Food Funct. 2018;9(2):705–714. doi:10.1039/c7fo01242j.
   PubMed Web of Science ®Google Scholar
• Kunnumakkara AB, Harsha C, Banik K, et al. Is curcumin bioavailability a problem in humans: lessons from clinical trials. Expert Opin Drug Metab Toxicol. 2019;15(9):705–733. doi:10.1080/17425255.2019.1650914.
   PubMed Web of Science ®Google Scholar
• Liu W, Zhai Y, Heng X, et al. Oral bioavailability of curcumin: problems and advancements. J Drug Target. 2016;24(8):694–702. doi:10.3109/1061186X.2016.1157883.
   PubMed Web of Science ®Google Scholar
• Ma Z, Wang N, He H, Tang X. Pharmaceutical strategies of improving oral systemic bioavailability of curcumin for clinical application. J Control Release. 2019;316:359–380. doi:10.1016/j.jconrel.2019.10.053.
   PubMed Web of Science ®Google Scholar
• Jourghanian P, Ghaffari S, Ardjmand M, Haghighat S, Mohammadnejad M. Sustained release curcumin loaded solid lipid nanoparticles. Adv Pharm Bull. 2016;6:17–21. doi:10.15171/apb.2016.04.
   PubMed Web of Science ®Google Scholar
• Ferrara M, Allegrini D, Sorrentino T, et al. Curcumin-based treatment for macular edema from uncommon etiologies: efficacy and safety assessment. J Med Food. 2020;23(8):834–840. doi:10.1089/jmf.2019.0241.
   PubMed Web of Science ®Google Scholar
• Noureddin SA, El-Shishtawy RM, Al-Footy KO. Curcumin analogues and their hybrid molecules as multifunctional drugs. Eur J Med Chem. 2019;182:111631. doi:10.1016/j.ejmech.2019.111631.
   PubMed Web of Science ®Google Scholar
• Maharjan P, Jin M, Kim D, et al. Evaluation of epithelial transport and oxidative stress protection of nanoengineered curcumin derivative-cyclodextrin formulation for ocular delivery. Arch Pharm Res. 2019;42:909–925. doi:10.1007/s12272-019-01154-9.
   PubMed Web of Science ®Google Scholar
• Granata G, Paterniti I, Geraci C, et al. Potential eye drop based on a Calix[4]arene nanoassembly for curcumin delivery: enhanced drug solubility, stability, and anti-inflammatory effect. Mol Pharm. 2017;14:1610–1622. doi:10.1021/acs.molpharmaceut.6b01066.
   PubMed Web of Science ®Google Scholar
• Kumari P, Muddineti OS, Rompicharla SVK, et al. Cholesterol-conjugated poly(D, L-lactide)-based micelles as a nanocarrier system for effective delivery of curcumin in cancer therapy. Drug Deliv. 2017;24:209–223. doi:10.1080/10717544.2016.1245365.
   PubMed Web of Science ®Google Scholar
• Zs Nagy N, Varga Z, Mihály J, Kasza G, Iván B. Kiss Highly efficient encapsulation of curcumin into and pH-controlled drug release from poly(ε-caprolactone) nanoparticles stabilized with a novel amphiphilic hyperbranched polyglycerol. Express Polym Lett. 2020;14:90–101. doi:10.3144/expresspolymlett.2020.8.
   Web of Science ®Google Scholar
• Danafar H, Davaran S, Rostamizadeh K, Valizadeh H, Hamidi M. Biodegradable m-PEG/PCL core-shell micelles: preparation and characterization as a sustained release formulation for curcumin. Adv Pharm Bull. 2014;4:501–510. doi:10.5681/apb.2014.074.
   PubMedGoogle Scholar
• Moussa Z, Hmadeh M, Abiad MG, Dib OH, Patra D. Encapsulation of curcumin in cyclodextrin-metal organic frameworks: dissociation of loaded CD-MOFs enhances stability of curcumin. Food Chem. 2016;212:485–494. doi:10.1016/j.foodchem.2016.06.013.
   PubMed Web of Science ®Google Scholar
• Allam AN, Komeil IA, Abdallah OY. Curcumin phytosomal softgel formulation: development, optimization and physicochemical characterization. Acta Pharm. 2015;65(3):285–297. doi:10.1515/acph-2015-0029.
   PubMed Web of Science ®Google Scholar
• Saheb M, Fereydouni N, Nemati S, Barreto GE, Johnston TP, Sahebkar A. Chitosan-based delivery systems for curcumin: a review of pharmacodynamic and pharmacokinetic aspects. J Cell Physiol. 2019;234(8):12325–12340. doi:10.1002/jcp.28024.
   PubMed Web of Science ®Google Scholar
• Mirzaei H, Shakeri A, Rashidi B, Jalili A, Banikazemi Z, Sahebkar A. Phytosomal curcumin: a review of pharmacokinetic, experimental and clinical studies. Biomed Pharmacother. 2017;85:102–112. doi:10.1016/j.biopha.2016.11.098.
   PubMed Web of Science ®Google Scholar
• Maiti K, Mukherjee K, Gantait A, Saha BP, Mukherjee PK. Curcumin-phospholipid complex: preparation, therapeutic evaluation and pharmacokinetic study in rats. Int J Pharm. 2007;330(1–2):155–163. doi:10.1016/j.ijpharm.2006.09.025.
   PubMed Web of Science ®Google Scholar
• Cuomo J, Appendino G, Dern AS, et al. Comparative absorption of a standardized curcuminoid mixture and its lecithin formulation. J Nat Prod. 2011;74(4):664–669. doi:10.1021/np1007262.
   PubMed Web of Science ®Google Scholar
• Allegri P, Mastromarino A, Neri P. Management of chronic anterior uveitis relapses: efficacy of oral phospholipidic curcumin treatment. Long-term follow-up. Clin Ophthalmol. 2010;4:1201–1206. doi:10.2147/OPTH.S13271.
   PubMedGoogle Scholar
• Miserocchi E, Giuffrè C, Cicinelli MV, et al. Oral phospholipidic curcumin in juvenile idiopathic arthritis-associated uveitis. Eur J Ophthalmol. 2020;30(6):1390–1396. doi:10.1177/1120672119892804.
   PubMed Web of Science ®Google Scholar
• Tugal-Tutkun I, Herbort CP. Laser flare photometry: a noninvasive, objective, and quantitative method to measure intraocular inflammation. Int Ophthalmol. 2010;30(5):453–464. doi:10.1007/s10792-009-9310-2.
   PubMedGoogle Scholar
• Gonzales CA, Ladas JG, Davis JL, Feuer WJ, Holland GN. Relationships between laser flare photometry values and complications of uveitis. Arch Ophthalmol. 2001;119(12):1763–1769. doi:10.1001/archopht.119.12.1763.
   PubMedGoogle Scholar
• Soleimani V, Sahebkar A, Hosseinzadeh H. Turmeric (Curcuma longa) and its major constituent (curcumin) as nontoxic and safe substances: review. Phytother Res. 2018;32(6):985–995. doi:10.1002/ptr.6054.
   PubMed Web of Science ®Google Scholar
• Lombardi N, Crescioli G, Maggini V, et al. Acute liver injury following turmeric use in Tuscany: an analysis of the Italian phytovigilance database and systematic review of case reports. Br J Clin Pharmacol. 2020 Jul 13. doi:10.1111/bcp.14460. Epub ahead of print.
   Google Scholar