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Table 1 Summary of GC RCTs reporting infection outcomes

From: The association between systemic glucocorticoid therapy and the risk of infection in patients with rheumatoid arthritis: systematic review and meta-analyses

First author and year Country Setting/Population Arms of RCT (n) Duration of study Type of outcome Result
Boers, 1997 [15] The Netherlands and Belgium 155 early RA patients from 8 centers Combination therapy - step-down prednisolone from 60 mg, step-down MTX and SSZ (76) vs SSZ monotherapy (79) 28 weeks Infections treated as outpatient 12 infections in combination arm, 6 in SSZ monotherapy arm
Chamberlain, 1976 [16] UK 49 adult RA patients from single center 5 mg prednisolone (20) vs
3 mg prednisolone (10) vs
0 mg prednisolone (19)
Allowed concomitant gold
2- 3.5 years n/a No infections
Choy, 2005 [17] UK 91 patients with established RA with incomplete response to DMARDs. Multicenter study Monthly 120-mg intramuscular depomedrone (48) vs placebo (43)
Allowed usual DMARDs
2 years n/a No infections either arm
Choy, 2008 [18] UK 467 patients within 2 years of diagnosis from 42 centers MTX (117)
MTX + cyclosporin (119)
MTX + step-down prednisolone (115)
MTX + cyclosporin + prednisolone (116)
2 years a) All-site serious infections
b) Respiratory tract infections
a) 7, 3, 4, and 2 serious infections in the four respective arms
b) 54, 51, 49, and 55 respiratory tract infections in the four respective arms
Durez, 2007 [19] Belgium 44 patients with early RA MTX monotherapy (14)
MTX + 1 g iv methylprednisolonea (15)
MTX + infliximaba (15)
Infusions weeks 0, 2, 6; then 8 weekly
46 weeks a) Serious infection
b) 'benign' infection
a) No serious infections in any arm
b) 14, 12, and 12 benign infections in the three arms, respectively
Durez, 2004 [20] Belgium 27 patients with active RA despite MTX MTX + 1 g iv MP week 0 (15)
MTX + infliximab weeks 0, 2, and 6 (12)
14 weeks Serious infections None in either arm
Gerlag, 2004 [21] The Netherlands 21 patients with active RA despite DMARDs 60 mg prednisolone week 1, then 40 mg prednisolone week 2 (10)
Placebo (11)
2 weeks n/a 1 skin infection in placebo arm only
Heytman, 1994 [22] Australia 60 patients with active RA previously treated with NSAIDs Gold plus either 1 g iv methylprednisolone weeks 0, 4, and 8 (30) or placebo (30) 24 weeks All patient-reported side effects No infections reported
Jasani, 1968 [23] UK 9 patients with erosive RA 4 × 1-week crossover study of ibuprofen 750 mg, aspirin 5 g, prednisolone 15 mg, and lactose as placebo 4 weeks n/a No infections reported
Kirwan, 2004 [24] Belgium, Sweden, UK 143 patients with active RA Budesonide, 3 mg (37), budesonide, 9 mg (36), prednisolone, 7.5 mg (39), placebo (31) 12 weeks a) Respiratory infections
b) Viral infections
a) 7, 4, 6, and 1 respiratory infections in the 4 groups, respectively.
b) 4, 1, 0, and 0 viral infections in the four groups, respectively
Liebling, 1981 [25] US 10 patients with active RA Crossover trial of monthly 1-g iv methylprednisolone vs placebo 12 months (6 months per arm) n/a 4 infections on placebo, 2 on GC
Murthy, 1978 [26] UK 24 patients with > 30 minutes morning stiffness Indomethacin, 25 mg × 4 (12), prednisolone, 5 mg (12) 2 weeks n/a No infections reported
Sheldon, 2003 [27] UK 26 patients with active RA Budesonide (14) or placebo (12) plus usual DMARDs 4 weeks n/a 2 cases of influenza (one from each group).
Van Everdingen, 2002 [28] The Netherlands 81 patients with active, previously untreated RA 10-mg prednisolone (40), placebo (41) 2 years Data reported on infections treated with antibiotics 17 infections in 40 patients in GC arm, 22 infections in 41 patients in placebo arm
Wassenberg, 2005 [29] Germany/Austria/Switzerland 192 patients with active RA, disease duration < 2 years Gold or MTX plus either 5 mg prednisolone (93) or placebo (96) 2 years All adverse events collected, reported only if occurred in 3 or more patients Total 4/93 and 3/96 (Bronchitis in 3/93 prednisolone group, 0/96 placebo group. Influenza in 1/93 prednisolone group, 3/96 placebo)
Williams, 1982 [30] UK 20 patients with active RA 1-g iv methylpredisonolone (10) or placebo (10) 6 weeks "Serious side effects" None reported
Wong, 1990 [31] Australia 40 patients with active RA previously treated with NSAIDs Gold plus either three pulses of 1 g intravenous methylprednisolone weeks 0, 4, + 8 (20) or placebo (20) 24 weeks Patients interviewed for all possible side effects 1 injection-site infection in placebo group
Capell, 2004 [32] UK 167 patients with active RA on no DMARD therapy SSZ plus either 7 mg prednisolone (84) or placebo (83) 2 years Withdrawals due to side effects No discontinuations due to infection in either group
Svensson, 2005 [33] Sweden 250 patients with active disease on DMARD therapy DMARD + prednisolone, 7.5 mg (119), DMARD alone, open, no placebo (131) 2 years Adverse events leading to withdrawal 1 abscess in non-prednisolone group. No infections leading to discontinuation in prednisolone group
Van der Veen, 1993 [34] The Netherlands 30 patients with active RA Oral MTX plus either placebo (10) or 100 mg oral prednisolone days 1, 3, and 5 (10) or 1 g iv MP days 1, 3, and 5 (10) 1 year Adverse events leading to discontinuation of MTX 1 pneumonia in placebo group (at week 12)
van Schaardenburg, 1995 [35] The Netherlands 56 patients with active RA aged > 60 previously treated with NSAIDs Chloroquine, 100 mg/day (28) (rescue with gold, then SSZ allowed) vs prednisolone 15 mg/day, tapered after 1 month (28) 2 years Withdrawal due to adverse advents No discontinuations due to infections in either group
  1. DMARD, disease-modifying antirheumatic drug; iv, intravenous; ivMP, intravenous methylprednisolone; MTX, methotrexate; NSAIDs: nonsteroidal anti-inflammatory drugs; RA, rheumatoid arthritis; SSZ, sulfasalazine. aInfusions weeks 0, 2, 6; then 8 weekly.