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Table 2 Efficacy outcome reporting of gout flare prophylaxis and therapy use with renal function stratification

From: Efficacy and safety of gout flare prophylaxis and therapy use in people with chronic kidney disease: a Gout, Hyperuricemia and Crystal-Associated Disease Network (G-CAN)-initiated literature review

First Author (Year)
(Trial Name)
Study Design Renal Function Exclusion Criteria or Baseline Renal Function – eGFR/CrCl (mL/min/1.73m2) or Serum Creatinine Level Clinical Indication for Gout Flare Actual/Mean Gout Flare Prophylaxis and Therapy Dose Number of Participants by eGFR/CrCl at Baseline (mL/min/1.73m2) Total, n Efficacy Data with Renal Function Stratification
≥90 60–90 30–60 < 30
COLCHICINE
AKDAG 2006 [17] Case report eGFR of 22 (serum creatinine of 3.1 mg/dL) Gout flare prophylaxis 0.5 mg PO twice daily (for at least 15 years)     1 1 Efficacy data not available. Renal function deteriorated (serum creatinine peaked at 7.6 mg/dL) during an episode of pneumonia requiring antibiotics (clarithromycin and cefepime).
ALAYLI 2005 [18] Case report eGFR of 44 (serum creatinine of 1.3 mg/dL) Gout flare treatment 1.5 mg PO daily (for few days)    1   1 Gout flare resolution was achieved without worsening renal function (serum creatinine of 1.1 mg/dL – baseline of 1.3 mg/dL)
ALTMAN 2007 [20] Case report eGFR of 34 (serum creatinine of 2 mg/dL) Gout flare treatment 1.5 mg PO daily (for at least 1 week)    1   1 Efficacy data not available. Renal function deteriorated (serum creatinine peaked at 2.56 mg/dL).
BONNEL 2002 [22] Case series eGFR of 29 (serum creatinine of 2.3 mg/dL) Gout flare treatment 2 mg IV loading dose, followed by 0.5 mg IV every 2 h until diarrhoea developed (total dose of 5.5 mg in 5 h)     1 1 Efficacy data not available. Renal function deteriorated rapidly (serum creatinine peaked at 4.9 mg/dL).
BOUQUIÉ 2011 [24] Case report eGFR of 32 (serum creatinine of 216 μmol/l) Gout flare treatment 1 mg PO three times daily on day 1, 1 mg twice daily on day 2 and 3, and 1 mg once daily for 3 days    1   1 Efficacy data not available (colchicine was self-ceased after day 6). Renal function deteriorated on day 8 (serum creatinine peaked at 370 μmol/l).
ELEFTHERIOU 2008 [28] Case report ESRD with eGFR of 6–8 Gout flare treatment 1 mg PO daily (for at least 6 days)     1 1 Efficacy data not available. Renal function was stable.
GARROUSTE 2012 [29] Case report Renal transplant with eGFR of 41 (serum creatinine of 160 μmol/l) Gout flare treatment 3 mg PO daily for 7 days     1 1 Efficacy data not available. Renal function deteriorated (serum creatinine peaked at 512 μmol/l), but gradually recovered on day 34 (serum creatinine of 188 μmol/l).
HUH 2013 [31] Case report Renal transplant with eGFR of 34 (serum creatinine of 1.65 mg/dL) Gout flare treatment 0.3 mg PO twice daily (for at least 3 weeks)    1   1 Efficacy data not available. Renal function deteriorated but returned to baseline 2 weeks after colchicine cessation.
JUSTINIANO 2007 [32] Case report eGFR of 57 (serum creatinine of 1.6 mg/dL) Gout flare treatment 0.6 mg PO twice daily (for at least 2 weeks)    1   1 Efficacy data not available. Renal function deteriorated (serum creatinine peaked at 1.7 mg/dL).
KUBLER 2000 [33] Case report eGFR of 26 (serum creatinine of 160 μmol/l) Gout flare treatment 0.5 mg PO three times daily (for at least 12 days)     1 1 Gout flare resolution was achieved within 48 h, but ARF developed (serum creatinine peaked at 450 μmol/l) in the context of ongoing colchicine use (same dose and frequency).
LAI 2006 [35] Case report eGFR of 9 (serum creatinine of 565.8 μmol/l) Gout flare treatment 0.5 mg PO three times daily for 3 days on a monthly basis (for at least 1 year); recent gout flare treatment with 0.5 mg PO twice daily (for at least 2 weeks)     1 1 Efficacy data not available. Renal function deteriorated (serum creatinine peaked at 680.7 μmol/l).
LEE 1997 [36] Case report Renal transplant with eGFR of 49 (serum creatinine of 1.6 mg/dL) Gout flare treatment 0.5 mg PO twice daily for 3 days    1   1 Efficacy data not available. Renal function deteriorated (serum creatinine peaked at 2.7 mg/dL) but returned to baseline upon colchicine cessation.
LY 2007 [37] Audit (single centre) Patients with CKD (defined as serum creatinine of0.17 mmol/L or CrCl of < 0.83) Gout flare treatment 2.5 mg PO over 24 h or less   22 22 Efficacy data not available.
MEDANI 2016 [39] Case series CKD Stage 3b-4 (serum creatinine of 300 μmol/l in patient 1 and 200 μmol/l in patient 2) Gout flare treatment Patient 1: 0.5 mg PO three times daily for 6 weeks
Patient 2: 0.5 mg PO once daily for at least 6 months
   1 1 2 Efficacy data not available. Renal function deteriorated for both patients (serum creatinine peaked at 526 μmol/l in patient 1 and 255 μmol/l in patient 2).
NEUSS 1986 [44] Case report eGFR of 23 (serum creatinine of 2.3 mg/dL) Gout flare prophylaxis 0.6 mg PO twice daily (long term)     1 1 No gout flare during therapy, but with multi-organ failure, including AKI (serum creatinine peaked at 3 mg/dL).
PATEL 2016 [46] Case report eGFR of 32 (serum creatinine of 1.87 mg/dL) Gout flare prophylaxis 0.6 mg PO once daily (for > 5 years)    1   1 Efficacy data not available. Renal function deteriorated (serum creatinine peaked at 2.5 mg/dL) but returned to baseline upon colchicine cessation.
RIEGER 1990 [49] Case report ESRD with eGFR of < 30 on haemodialysis and underlying renal transplant Gout flare prophylaxis 0.6 mg PO twice daily     1 1 Efficacy data not available.
WILBUR 2004 [53] Case series Patient 1: ESRD on peritoneal dialysis
Patient 2: CKD Stage 3
Gout flare treatment 0.6 mg PO (variable frequency)    1 1 2 Patient 1: ongoing treatment due to recurrent flare (despite 0.6 mg PO three times daily for the first 3 days). Renal function worsened.
Patient 2: ongoing treatment due to recurrent gout flare for at least 2 weeks (dosing was increased from 0.6 mg PO once daily to three times daily). Renal function was stable.
YOON 2001 [55] Case report eGFR of 39 (serum creatinine of 134 μmol/l) Gout flare treatment 0.5 mg PO three times daily (total dose of 4.5 mg)    1   1 Gout flare persisted. Renal function deteriorated (CrCl peaked at 30 mL/min/1.73m2).
ZAGLER 2009 [57] Case report eGFR of 34 Gout flare treatment 1 mg PO once off dosing    1   1 Efficacy data not available. However, renal function deteriorated (serum creatinine increased from 2.4 to 5.2 mg/dL).
IL-1 INHIBITORS
ADLER 2007 [67] Case report eGFR of 27–30 Gout flare treatment Anakinra 100 mg/d for 3 days     1 1 Complete clinical remission with stable renal function.
AOUBA 2015 [68] Case series (single-centre) eGFR of 20–40 Gout flare treatment Anakinra 100 mg/d (up to 6 days) 1 1 1   3 2 patients achieved complete clinical remission after 5 days of treatment. 1 patient who received initial 3-day treatment required a second course (5-day period) due to recurrent gout flare. Renal function remained stable.
BARTOV 2013 [69] Case report eGFR of < 20 Gout flare treatment Anakinra 100 mg every other day for 1 week     1 1 Complete clinical remission with no worsening renal function.
DIREZ 2012 [71] Case report CrCl of 14 mL/min/1.73m2 Gout flare treatment Anakinra 100 mg/d for 5 days, followed by re-dosing of alternate-daily 100 mg dosing for 2 months (commenced 1 week after the first therapy)     1 1 Partial responder for the first course of treatment. During the second treatment, renal function deteriorated after 2 months (CrCl declined to 6 mL/min/1.73m2).
LOUSTAU 2018 [76] Case series (multi-centre) CKD stage 4–5 (mean eGFR 22 ± 6.6) and history of renal transplant (mean eGFR 41 ± 22.8) Gout flare treatment Anakinra 100 mg/d (except in 5 patients who had 100 mg every 48–72 h) for less than a week; in 10 patients, dose was maintained for > 15 days (up to 14 months) with progressive dose spacing due to frequent gout flare    6 25 31 Pooled efficacy outcome: complete clinical remission with a mean of 46 days (range 4–90 days). Decrease in pain VAS from 69.6 ± 13.4 mm to 10.4 ± 15.3 mm and CRP level from 160 ± 133 mg/mL to 11 ± 11 mg/mL. No significant change in eGFR (26.3 pre-treatment vs 26.9 post-treatment).
MAROTTO 2018 [77] Case report CKD stage 3 (CrCl of 56.47 mL/min/1.73m2) Gout flare treatment Canakinumab 100 mg single dose    1   1 Rapid clinical response 12 h after canakinumab administration. No worsening renal function.
PEREZ-RUIZ 2013 [81] Case series (single centre)
EULAR abstract
CKD stage 3–4 Gout flare treatment Anakinra 100 mg/d (varying duration) 2   6   8 Pooled efficacy outcome: reduction in hsCRP level from 5.7 ± 7.3 to 0.56 ± 1.07 at 6 months post-treatment. Renal function remained stable (baseline CrCl 68 ± 28 vs 74 ± 43 at 6th month).
TRAN 2011 [83] Case series eGFR of 57 (serum creatinine of 118 μmol/l) Gout flare treatment Anakinra 100 mg/d    1   1 Clinical remission was achieved with CRP reduction. Renal function remained stable.
NON-STEROIDAL ANTI-INFLAMMATORY DRUGS
KAHL 1989 [84] Case series Patient 1: eGFR of 32 (serum creatinine of 2.4 mg/dL)
Patient 2: eGFR of 21 (serum creatinine of 3.3)
Gout flare treatment Sulindac 200 mg twice daily and indomethacin 50 mg three times daily    1 1 2 No improvement in gout flare. Acute kidney injury developed in both patients.
SCHLONDORFF 1993 [86] Case report Creatinine clearance of 70 (serum creatinine of 1.8 mg/dL) Gout flare treatment Indomethacin 50 mg three times daily   1    1 Gout flare improved rapidly. Acute kidney injury ensued.
ZAGLER 2009 [57] Case report eGFR of 34 Gout flare treatment Diclofenac 100 mg/d    1   1 No improvement in gout flare. However, renal function deteriorated (serum creatinine increased from 2.4 to 5.2 mg/dL).
GLUCOCORTICOIDS
TAUSCHE 2011 [95] Case report eGFR of 30 Gout flare prophylaxis Prednisone 10 mg/d    1   1 Improvement in frequency of gout flare (in combination with regular low-dose colchicine use and low-dose NSAID as required; the duration for the gout flare prophylaxis use was not known). Renal function remained stable.
ZAGLER 2009 [57] Case report eGFR of 34 Gout flare treatment Prednisone 40 mg/d    1   1 Gout flare treatment was effective. However, renal function deteriorated (serum creatinine increased from 2.4 to 5.2 mg/dL).
  1. AKI acute kidney injury, CKD chronic kidney disease, CRP C-reactive protein, CrCl creatinine clearance, eGFR estimated glomerular filtration rate, ESRD end-stage renal disease, hsCRP highly sensitive C-reactive protein, IV intravenous, PO per os (by mouth), VAS visual analogue score