A randomised placebo controlled 12 week trial of budesonide and prednisolone in rheumatoid arthritis

Annals of the Rheumatic Diseases

Volumn 63, Issue 6, 2004, Pages 688-695

  Kirwan, J R ^a   Hallgren R ^b   Mielants, H ^c   Wollheim, F ^d   Bjorck, E ^e   Persson, T ^e   Book, C ^d   Bowman, S ^f   Byron, M ^g   Cox, N ^h   Field, M ⁱ   Kanerud, L ^j   Leirisalo Repo, M ^d   Malaise, M ^k   Mohammad, A ^b   Palmer, R ^l   Petersson, I F ^m   Ringertz, B ^j   Sheldon, P ⁿ   Simonsson, M ^f   Snowden, N ^o   Van Den Bosch, F ^c   more..

^a BRISTOL ROYAL INFIRMARY   (United Kingdom)

^b UPPSALA UNIVERSITY HOSPITAL   (Sweden)

^c GHENT UNIVERSITY HOSPITAL   (Belgium)

^d LUND UNIVERSITY HOSPITAL   (Sweden)

^e ASTRAZENECA R AND D   (Sweden)

^f Universitetssjukhuset MAS ^*

^g Westan Super Mare   (United Kingdom)

^h ROYAL HAMPSHIRE COUNTY HOSPITAL   (United Kingdom)

ⁱ GLASGOW ROYAL INFIRMARY   (United Kingdom)

^j KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

^k UNIVERSITY OF LIÈGE   (Belgium)

^l SOLIHULL HOSPITAL   (United Kingdom)

^m Spenshult   (Sweden)

ⁿ LEICESTER ROYAL INFIRMARY   (United Kingdom)

^o NORTH MANCHESTER GENERAL HOSPITAL   (United Kingdom)

more..

Author keywords

[No Author keywords available]

Indexed keywords

BUDESONIDE; GLUCOCORTICOID; PLACEBO; PREDNISOLONE;

ABDOMINAL PAIN; ACNE; ADULT; ANEMIA; ANGINA PECTORIS; ANKLE EDEMA; ARTICLE; BACKACHE; BUFFALO HUMP; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORONARY ARTERY ATHEROSCLEROSIS; DEPRESSION; DIARRHEA; DISEASE CONTROL; DISEASE EXACERBATION; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG EXPOSURE; DRUG RESPONSE; DRUG WITHDRAWAL; DYSPEPSIA; FEMALE; GASTROINTESTINAL SYMPTOM; GENERAL CONDITION IMPROVEMENT; HAIR LOSS; HEADACHE; HEART DISEASE; HEMATURIA; HIRSUTISM; HUMAN; INSOMNIA; MAJOR CLINICAL STUDY; MALE; MOOD DISORDER; MOOD SWING; MOON FACE; PAIN; PRIORITY JOURNAL; PURPLE SKIN STRAIE; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT INFECTION; RHEUMATOID ARTHRITIS; SIDE EFFECT; SKIN BRUISING; SKIN DISCOLORATION; SWEATING; SYMPTOMATOLOGY; VIRUS INFECTION;

EID: 2442716571     PISSN: 00034967     EISSN: None     Source Type: Journal    
DOI: 10.1136/ard.2003.008573     Document Type: Article

References (36)

1. Sheldon P. Rheumatoid arthritis and gut related lymphocytes: the iteropathy concept. Ann Rheum Dis 1988;47:697-700.
2. Porzio V, Biasi G, Corrado A, De Santi M, Vindigni C, Viti S, et al. Intestinal histological and ultrastructural inflammatory changes in spondyloarthropathy and rheumatoid arthritis. Scand J Rheumatol 1997;26:92-8.
3. Toivanen P. From reactive arthritis to rheumatoid arthritis. Autoimmunity 2001;16:369-71.
4. St Clair EW, Wilkinson WE, Pisetsky DS, Sexton DJ, Drew R, Kraus VB, et al. The effects of intravenous doxycycline therapy for rheumatoid arthritis: a randomized, double-blind, placebo-controlled trial. Arthritis Rheum 2001;44:1043-7.
5. Cordain L, Toohey L, Smith MJ, Hickey MS. Modulation of immune function by dietary lectins in rheumatoid arthritis. Br J Nutr 2000;83:207-17.
6. Muller H, de Toledo FW, Resch KL. Fasting followed by vegetarian diet in patients with rheumatoid arthritis: a systematic review. Scand J Rheumatol 2001;30:1-10.
7. Mielants H, Veys EM, Cuvelier C, De Vos M. Course of gut inflammation in spondylarthropathies and therapeutic consequences. Baillieres Clin Rheumatol 1996;10:147-64.
8. Veys EM, Mielants H, De Vos M, Cuvelier C. Spondylarthropothies: from gut to target organs. Baillieres Clin Rheumatol 1996;10:123-46.
9. Gotzsche PC, Johansen HK. Short-term, low-dose corticosteroids and nonsteroidal anti-inflammatory drugs for rheumatoid arthritis. The Cochrane Library. Oxford: Update Software, 1999.
10. Saag KG, Criswell LA, Sems KM, Nettleman MD, Kolluri S. Low-dose corticosteroids in rheumatoid arthritis: a meta-analysis of their moderate-term effectiveness. Arthritis Rheum 1996;39:1818-25.
11. van Everdingen AA, Jacobs JW, Siewertsz Van Reesema DR, Bijlsma JW. Low-dose prednisone therapy for patients with early active rheumatoid arthritis: clinical efficacy, disease-modifying properties, and side effects: a randomized, double-blind, placebo-controlled clinical trial. Ann Intern Med 2002 Jan 1;136:1-12.
12. Kirwan JR, ARC Low Dose Glucocorticoid Study Group. The effect of glucocorticoids on joint destruction in rheumatoid arthritis. N Engl J Med 1995;333:142-6.
13. Edsbäcker S, Wollmer P, Nilsson A, Nilsson M. Pharmacokinetics and gastrointestinal transit of budesonide controlled ileal release (CIR) capsules [abstract]. Gastroenterology 1993;104:A695.
14. Edsbäcker S, Larsson P, Nilsson M, Wirén JE. Budesonide controlled ileal release (CIR) capsules affect plasma cortisol less than prednisolone [abstract]. Gastroenterology 1995;108(suppl 4):A814.
15. Danielsson Å, Hellers G, Lyrenäs E, Löfberg R, Nilsson Å, Olsson O, et al. A controlled randomized trial of budesonide versus prednisolone retention enemas in active distal ulcerative colitis. Scand J Gastroenterol 1987;22:987-92.
16. Tarpila S, Turunen U, Seppälä K, Aukee S, Pikkarainen P, Elomaa I, et al. Budesonide enema in active haemorrhagic proctitis: a controlled trial against hydrocortisone foam enema. Aliment Pharmacol Ther 1994;8:591-5.
17. Rutgeerts P, Löfberg R, Malchow H, Lamers C, Olaison G, Jewell D, et al. A comparison of budesonide with prednisolone for active Crohn's disease. N Engl J Med 1994;331:842-5.
18. Östergaard Thomsen O, Cortot A, Jewell D, Wright JP, Winter T, Tavarela Veloso F, et al. A comparison of budesonide and mesalazine for active Crohn's disease (the international budesonide-mesalamine study group). N Engl J Med 1998;339:370-4.
19. Arnett FC, Edworthy SM, Bloch DA, McShane DJ, Fries JF, Cooper NS, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum 1988;31:315-24.
20. Steinbrocker O, Traegar CH, Batterman RC. Therapeutic criteria in rheumatoid arthritis. JAMA 1949;140.659-62.
21. Boers M, Tugwell P, Felson DT, van Riel PL, Kirwan JR, Edmonds JP, et al. World Health Organization and International League of Associations for Rheumatology core end points for symptom modifying antirheumatic drugs in rheumatoid arthritis clinical trials. J Rheumatol 1994;21(suppl 41):86-9.
22. Fuchs HA, Brooks RH, Callahan L Pincus T. A simplified twenty-eight-joint quantitative articular index in rheumatoid arthritis. Arthritis Rheum 1989;32:531-7.
23. Fries JF, Spitz P, Kraines RG, Holman HR. Measurement of patient outcome in arthritis. Arthritis Rheum 1980;23:137-45.
24. MAPI Research Institute. Cultural adaption of the health assessment questionnaire (HAQ) into Belgian Dutch, Belgian French, Swedish and UK English. Report prepared by MAPI Research Institute, August 1998. Report on file, at AstraZeneca, Lund, Sweden.
25. Kirwan JR, Reeback JS. Stanford Health Assessment Questionnaire modified to assess disability in British patients with rheumatoid arthritis. Br J Rheumatol 1986;25:206-9.
26. Ware J, Sherbourne DC. The MOSS 36 item short-form health survey (SF-36). Med Care 1992;30:473-83.
27. Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum 1995;38:727-35.
28. Edsbäcker S, Nilsson M, Larsson P. A cortisol suppression dose-response comparison of budesonide in controlled ileal release capsules with prednisolone. Aliment Pharmacol Ther 1999;13:219-24.
29. Criswell LA, Saag KG, Sems KM, Welch V, Shea B, Wells G, et al. Moderate-term, low-dose corticosteroids for rheumatoid arthritis (Cochrane review). The Cochrane Library, Issue 4. Oxford: Update Software, 2000.
30. Empire Rheumatism Council Subcommittee. Multi-Center controlled trial comparing cortisone acetate and acetyl salicylic acid in the long-term treatment of rheumatoid arthritis. Ann Rheum Dis 1955;14:353-63.
31. Harris E D, Emkey RD, Nichols JE, Newberg A. Low dose prednisone therapy in rheumatoid arthritis: a double blind study. J Rheumatol 1983;10:713-21.
32. Million R, Poole P, Kellgren, H, Jayson MIV. Long-term study management of rheumatoid arthritis. Lancet 1984;ii:812-16.
33. Stenberg VI, Fiechtner JJ, Rice JR, Miller DR, Johnson LK. Endocrine control of inflammation: rheumatoid arthritis double-blind, crossover clinical trial. Int J Clin Pharmacol Res 1992;12:11-18.
34. Van Gestel AM, Laan RFJM, Haagsma CJ, van de Putte LBA, van Riel PLCM. Low-dose oral steroids as bridge therapy in rheumatoid arthritis patients starting with parenteral gold: a randomized double-blind placebo-controlled trial. Br J Rheumatol 1995;34:347-51.
35. Van Schaardenburg D, Valkema R, Dijkmans BAC, Papapoulos S, Zwinderman AH, Han KH, et al. Prednisone for elderly-onset rheumatoid arthritis: outcome and bone moss in comparison to treatment with chloroquine. Arthritis Rheum 1995;38:334-42.
36. Ritchie DM, Bayle JA, Mclnnes JM, Jasani MK, Dalakos T, Grieveson P, et al. Clinical studies with an articular index for the assessment of joint tenderness in patients with rheumatoid arthritis. Q J Med 1968;147:393-406.