Efficacy, safety and mechanism of action of modified-release prednisone in rheumatoid arthritis

Therapeutic Advances in Musculoskeletal Disease

Volumn 4, Issue 3, 2012, Pages 159-166

  Clarke, Lynsey ^a   Kirwan, John ^a  

^a BRISTOL ROYAL INFIRMARY   (United Kingdom)

Author keywords

chronotherapy; glucocorticoids; modified release prednisone; rheumatoid arthritis; safety

Indexed keywords

DISEASE MODIFYING ANTIRHEUMATIC DRUG; GLUCOCORTICOID; INFLIXIMAB; INTERLEUKIN 6; METHOTREXATE; PLACEBO; PREDNISONE;

ARTICLE; CIRCADIAN RHYTHM; DOSAGE SCHEDULE COMPARISON; DRUG DOSAGE FORM COMPARISON; DRUG EFFICACY; DRUG MECHANISM; DRUG MEGADOSE; DRUG RELEASE; DRUG SAFETY; DRUG TARGETING; EVENING DOSAGE; GLAUCOMA; GLYCEMIC CONTROL; HUMAN; HYPERTENSION; HYPOTHALAMUS DISEASE; HYPOTHALAMUS HYPOPHYSIS ADRENAL SYSTEM; IMMUNE DEFICIENCY; JOINT STIFFNESS; LOW DRUG DOSE; MORNING DOSAGE; OPEN STUDY; PRIORITY JOURNAL; PROTEIN BLOOD LEVEL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RHEUMATOID ARTHRITIS; SIDE EFFECT; SKIN BRUISING; UNSPECIFIED SIDE EFFECT; WEIGHT GAIN;

EID: 84868670147     PISSN: 1759720X     EISSN: 17597218     Source Type: Journal    
DOI: 10.1177/1759720X12441274     Document Type: Article

References (49)

1. Alten R. Doring G. Cutolo M. Gromnica-Ihle E. Witte S. Straub R. Buttgereit F. (2010) Hypothalamus-pituitary-adrenal axis function in patients with rheumatoid arthritis treated with nighttime-release prednisone. J Rheumatol 37: 2025–2031.
2. Alvarez-Rodriguez L. Lopez-Hoyos M. Mata C. Jose Marin M. Calvo-Alen J. Blanco R. et al. (2010) Circulating cytokines in active polymyalgia rheumatica. Ann Rheum Dis 69: 263–269.
3. Arvidson N.G. Gudbjornsson B. Elfman L. Ryden A. Totterman T.H. Hallgren R. (1994) Circadian rhythm of serum interleukin-6 in rheumatoid arthritis. Ann Rheum Dis 53: 521–524.
4. Arvidson N.G. Gudbjornssen B. Larsson A. Hallgren R. (1997) The timing of glucocorticoid administration in rheumatoid arthritis. Ann Rheum Dis 56: 27–31.
5. Bellamy N. Sothern R.B. Campbell J. Buchanan W.W. (1991) Circadian rhythm in pain, stiffness, and manual dexterity in rheumatoid arthritis: relation between discomfort and disability. Ann Rheum Dis 50: 243–248.
6. Buttgereit F. Burmester G. Straub R. Seibel M. Zhou H. (2011 a) Exogenous and endogenous glucocorticoids in rheumatic diseases. Arthritis Rheum 63: 1–9.
7. Buttgereit F. Doering G. Schaeffler A. Witte S. Sierakowski S. Gromnica-Ihle E. et al. (2008) Efficacy of modified-release versus standard prednisone to reduce duration of morning stiffness of the joints in rheumatoid arthritis (CAPRA-1): a double-blind, randomised controlled trial. Lancet 371: 205–214.
8. Buttgereit F. Doering G. Schaeffler A. Witte S. Sierakowski S. Gromnica-Ihle E. et al. (2010) Targeting pathophysiological rhythms: prednisone chronotherapy shows sustained efficacy in rheumatoid arthritis. Ann Rheum Dis 69: 275–280.
9. Buttgereit F. Mehta D. Kirwan J. Szechinski J. Boers M. Alten R. et al. (2011 b) Low-dose glucocorticoid chronotherapy of rheumatoid arthritis: 12 week efficacy and safety of modified-release (MR) prednisone. Arthritis Rheum 62 (Suppl 10): 392.
10. Clarke L. Jessop D. Hunt L. Straub R. Perry M. Kirwan J. (2011) Alleviation of morning joint stiffness by low-dose prednisone in rheumatoid arthritis is associated with circadian changes in IL-6 and cortisol. Int J Clin Rheumatol 6: 241–249.
11. Criswell L. Saag K. Sems K. Welch V. Shea B. Wells G. et al. (1998) Moderate term, low-dose corticosteroids for rheumatoid arthritis. Cochrane Database Syst Rev: CD001158.
12. Crofford L. Kalogeras K. Mastorakos G. Magiakou M. Wells J. Kanik K. et al. (1997) Circadian relationships between interleukin (IL)-6 and hypothalamic-pituitary-adrenal axis hormones: failure of IL-6 to cause sustained hypercortisolism in patients with early untreated rheumatoid arthritis. J Clin Endocrinol Metab 82: 1279–1283.
13. Cutolo M. Straub R. (2000) Polymyalgia rheumatica: evidence for a hypothalamic-pituitary-adrenal axis-driven disease. Clin Exp Rheumatol 18: 655–658.
14. Cutolo M. Straub R. Foppiani L. Prete C. Pulsatelli L. Sulli A. et al. (2002) Adrenal gland hypofunction in active polymyalgia rheumatica. Effect of glucocorticoid treatment on adrenal hormones and interleukin 6. J Rheumatol 29: 748–756.
15. Da Silva J. Jacobs J. Kirwan J. Boers M. Saag K. Ines L. et al. (2006) Safety of low dose glucocorticoid treatment in rheumatoid arthritis: published evidence and prospective trial data. Ann Rheum Dis 65: 285–293.
16. Deandrade J.R. McCormick J.N.A. Hill A.G.S. (1964) Small doses of prednisolone in management of rheumatoid arthritis. Ann Rheum Dis 23: 158–162.
17. Debono M. Ghobadi C. Rostami-Hodjegan A. Huatan H. Campbell M. Newell-Price J. et al. (2009) Modified-release hydrocortisone to provide circadian cortisol profiles. J Clin Endocrinol Metab 94: 1548–1554.
18. Demir H. Tanriverdi F. Ozogul N. Calis M. Kirnip M. Durak A. et al. (2006) Evaluation of the hypothalamic-pituitary-adrenal axis in untreated patients with polymyalgia rheumatica and healthy control. Scand J Rheumatol 35: 217–223.
19. de Silva M. Binder A. Hazleman B. (1984) The timing of prednisolone dosage and its effect on morning stiffness in rheumatoid arthritis. Ann Rheum Dis 43: 790–793.
20. Goekoop-Ruiterman Y. de Vries-Bouwstra J. Allaart C. van Zeben D. Kerstens P. Hazes J. et al. (2005) Clinical and radiographic outcomes of four different treatment strategies in patients with early rheumatoid arthritis (the BeSt study): a randomized, controlled trial. Arthritis Rheum 52: 3381–3390.
21. Goekoop-Ruiterman Y. de Vries-Bouwstra J. Allaart C. van Zeben D. Kerstens P. Hazes M. et al. (2007) Comparison of treatment strategies in early rheumatoid arthritis: a randomized trial. Ann Intern Med 146: 406–415.
22. Gorter S. Bijlsma J. Cutolo M. Gomez-Reino J. Kouloumas M. Smolen J. et al. (2010) Current evidence for the management of rheumatoid arthritis with glucocorticoids: a systematic literature review informing the EULAR recommendations for the management of rheumatoid arthritis. Ann Rheum Dis 69: 1010–1014.
23. Gotzsche P.C. Johansen H.K. (1998) Meta-analysis of short term low dose prednisolone versus placebo and non-steroidal anti-inflammatory drugs in rheumatoid arthritis. BMJ 316: 811–818.
24. Harkness J. Rickter M. Panayi G. van de Pette K. Unger A. Pownall R. et al. (1982) Circadian variation in disease activity in rheumatoid arthritis. BMJ 284: 551–554.
25. Hench P. Kendall E. Slocumb C. Polley H. (1949) The effect of a hormone of the adrenal cortex (17-hydroxy-11-dehydrocorticosterone: compound E) and of pituitary adrenocorticotropic hormone on rheumatoid arthritis. Proc Staff Meet Mayo Clin 24: 181–197.
26. Hernandez-Rodriguez J. Sid M. Lopez-Soto A. Espigol-Figole G. Bosch X. (2009) Treatment of polymyalgia rheumatica. Arch Intern Med 169: 1839–1850.
27. Hoes J. Jacobs J. Verstappen S. Bijlsma J. van der Heijden G. (2009) Adverse events of low- to medium-dose oral glucocorticoids in inflammatory diseases: a meta-analysis. Ann Rheum Dis 68: 1833–1838.
28. Huscher D. Thiele K. Gromnica-Ihle E. Hein G. Demary W. Dreher R. et al. (2009) Dose-related patterns of glucorticoid-induced side efffects. Ann Rheum Dis 68: 1119–1124.
29. Jacobs J. Bijlsma J. (2010) Modified release prednisone in patients with rheumatoid arthritis. Ann Rheum Dis 69: 1257–1259.
30. Jacobs J. van Everdingen A. Verstappen S. Bijlsma J. (2006) Followup radiographic data on patients with rheumatoid arthritis who participated in a two-year trial of prednisone therapy or placebo. Arthritis Rheum 54: 1422–1428.
31. Jessop D.S. Harbuz M.S. (2005) A defect in cortisol production in rheumatoid arthritis: why are we still looking? Rheumatology 44: 1097–1100.
32. Kirwan J. (1995) The effect of glucocorticoids on joint destruction in rheumatoid arthritis. The Arthritis and Rheumatism Council Low-Dose Glucocorticoid Study Group. N Engl J Med 333: 142–146.
33. Kirwan J. (2011) Targeting the time of day for glucocorticoid delivery in rheumatoid arthritis. Int J Clin Rheum 6: 273–279.
34. Kirwan J. Bijlsma J. Boers M. Shea B. (2007) Effects of glucocorticoids on radiological progression in rheumatoid arthritis. Cochrane Database Syst Rev: CD006356.
35. Kirwan J. Zakout S. (2011) Polymyalgia rheumatica has a nocturnal rise in serum interleukin-6 which is almost completely suppressed by nighttime prednisone. Arthritis Rheum 63 (Suppl 27): 79.
36. Landewé R. Boers M. Verhoeven A. Westhovens R. van de Laar M. Markusse H. et al. (2002) COBRA combination therapy in patients with early rheumatoid arthritis: long-term structural benefits of a brief intervention. Arthritis Rheum 46: 347–356.
37. Metselaar J. Wauben M. Wagenaar-Hilbers J. Boerman O. Storm G. (2003) Complete remission of experimental arthritis by joint targeting of glucocorticoids with long-circulating liposomes. Arthritis Rheum 48: 2059–2066.
38. Nichols T. Nugent C. Tyler F. (1965) Diurnal variation in suppression of adrenal function by glucocorticoids. J Clin Endocrinol Metab 25: 343.
39. Perry M. Kirwan J. Jessop D. Hunt L. (2009) Overnight variations in cortisol, interleukin 6, tumour necrosis factor alpha and other cytokines in people with rheumatoid arthritis. Ann Rheum Dis 68: 63–68.
40. Roche N. Fulbright J. Wager A. Hunder G. Goronzy J. Weyand C. (1993) Correlation of interleukin-6 production and disease activity in polymyalgia rheumatica and giant cell arteritis. Arthritis Rheum 36: 1286–1294.
41. Salvarani C. Cantini F. Boiardi L. Hunder G. (2002) Polymyalgia rheumatica and giant-cell arteritis. N Engl J Med 347: 261–271.
42. Schäcke H. Rehwinkel H. Asadullah K. Cato A.l. (2006) Insight into the molecular mechanisms of glucocorticoid receptor action promotes identification of novel ligands with an improved therapeutic index. Exp Dermatol 15: 565–573.
43. Schäcke H. Zollner T. Docke W. Rehwinkel H. Jaroch S. Skuballa W. et al. (2009) Characterization of ZK 245186, a novel, selective glucocorticoid receptor agonist for the topical treatment of inflammatory skin diseases. Br J Pharmacol 158: 1088–1103.
44. Svensson B. Boonen A. Albertsson K. van der Heijde D. Keller C. Hafstrom I. (2005) Low-dose prednisolone in addition to the initial disease-modifying antirheumatic drug in patients with early active rheumatoid arthritis reduces joint destruction and increases the remission rate – a two-year randomized trial. Arthritis Rheum 52: 3360–3370.
45. van der Goes M. Jacobs J. Boers M. Andrews T. Blom-Bakkers M. Buttgereit F. et al. (2010) Monitoring adverse events of low-dose glucocorticoid therapy: EULAR recommendations for clinical trials and daily practice. Ann Rheum Dis 69: 1913–1919.
46. Wassenberg S. Rau R. Steinfeld P. Zeidler H. (2005) Very low-dose prednisolone in early rheumatoid arthritis retards radiographic progression over two years: a multicenter, double-blind, placebo-controlled trial. Arthritis Rheum 52: 3371–3380.
47. Westhoff G. Buttgereit F. Gromnica-Ihle E. Zink A. (2008) Morning stiffness and its influence on early retirement in patients with recent onset rheumatoid arthritis. Rheumatology 47: 980–984.
48. Yazici Y. Pincus T. Kautiainen H. Sokka T. (2004) Morning stiffness in patients with early rheumatoid arthritis is associated more strongly with functional disability than with joint swelling and erythrocyte sedimentation rate. J Rheumatol 31: 1723–1726.
49. Zimmermann G. Avery W. Finelli A. Farwell M. Frase C. Borisy A. (2009) Selective amplification of glucocorticoid anti-inflammatory activity through synergistic multi-target action of a combination drug. Arthritis Res Ther 11: 1–14.