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Sulphasalazine and Auranofin As Second Line Drugs in Ann Rheum Dis: First Published As 10.1136/Ard.51.4.461 on 1 April 1992

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Sulphasalazine and Auranofin As Second Line Drugs in Ann Rheum Dis: First Published As 10.1136/Ard.51.4.461 on 1 April 1992 Annals ofthe Rheumatic Diseases 1992; 51: 461-464 461 Prospective trial comparing the use of sulphasalazine and auranofin as second line drugs in Ann Rheum Dis: first published as 10.1136/ard.51.4.461 on 1 April 1992. Downloaded from patients with rheumatoid arthritis D Porter, R Madhok, J A Hunter, H A Capell Abstract the sulphasalazinegroup and 26 in the auranofin Two hundred patients with rheumatoid arth- group had previously received intramuscular ritis were studied in a prospective open trial gold treatment. Twenty nine patients had comparing treatment with sulphasalazine and previously been treated with either sulpha- auranofm in patients with active disease over salazine (25) or auranofin (four) and they were 12 months. The two drugs improved many assigned to receive the other drug. The remain- parameters ofdisease activity at 12, 24, and 48 ing patients were randomised to receive either weeks. At 12 weeks, the group treated with sulphasalazine or auranofin. Sulphasalazine was sulphasalazine had a lower platelet count given at a starting dose of 500 mg with weekly (Mann-Whitney U test), erythrocyte sedimen- increments of 500 mg to a target dose equivalent tation rate, and articular index, with a greater to 40 mg/kg/day in divided doses. Auranofin decrease in erythrocyte sedimentation rate was prescribed at 3 mg twice daily; the dose was (Students t test) and C reactive protein increased to 3 mg three times a day after three between 0 and 12 weeks. There were no months treatment if there was thought to have significant differences between sulphasalazine been a poor response to treatment. The patients, and auranofm treatment after 24 and 48 prescribing doctors, and metrologists were all weeks. Life table analysis showedno significant aware of the identity and dose of the drug differences in the rate of side effects which prescribed. The dose of the two drugs was caused treatment to be stopped. Sulpha- altered during the trial as clinical indications salazine works more rapidly, may be a more dictated, either because of a poor response or effective disease modifying antirheumatic because of the occurrence of side effects. drug, and is as well tolerated as auranofin. Concomitant treatment with non-steroidal anti- inflammatory drugs (NSAIDs) was continued. Information was recorded about the patients' Sulphasalazine and auranofin are established age, sex, duration of disease, and rheumatoid second line or disease http://ard.bmj.com/ modifying antirheumatic factor status. The patients were assessed at 0, drugs (DMARDs) used in the treatment of 12, 24, and 48 weeks for the following laboratory rheumatoid arthritis. They have been shown in and clinical parameters of disease activity: both open and double blind placebo controlled Ritchie articular index, a 10 cm visual analogue trials to exert a beneficial effect on many clinical pain scale, duration of morning and laboratory parameters of disease activity. stiffness, There evidence to erythrocyte sedimentation rate, C reactive is, however, little suggest protein, and platelet count. The clinical that is because of on September 28, 2021 by guest. Protected copyright. either preferable greater parameters were assessed by one of two nurse efficacy, more rapid effect, or lower toxicity. metrologists and each patient was seen by the Such a difference would affect practical pre- same metrologist each time; the services of the scribing habits. Therefore a prospective, metrologists were equally distributed between randomised comparative trial of sulphasalazine the two drugs. and auranofin was undertaken in a large group of patients with rheumatoid arthritis in a Where appropriate, non-parametric analysis routine clinical environment. within groups (paired Wilcoxon) and between Centre for groups (Mann-Whitney) was performed. Rheumatic Diseases, Kolmogorov-Smirnov goodness of fit testing Glasgow Royal Patients and methods Infirmary, suggested the change in each parameter (except Castle Street, Two hundred patients with definite or classical morning stiffness) to be normally distributed; Glasgow, RA, from two hospitals in Glasgow, were between group analysis used Student's t test United Kingdom selected as requiring second line treatment with D Porter with 95% confidence intervals. The rate of R Madhok drugs on the basis of active synovitis or pro- stopping treatment because of side effects was H A Capell longed morning stiffness (with or without an analysed by life table and x2 analysis. Gartnavel General increased erythrocyte sedimentation rate or C Owing to the possible bias introduced by Hospital, Glasgow, reactive protein). Patients receiving cortico- including patients who had previously received United Kingdom steroids by mouth were excluded. Patients J A Hunter intramuscular gold treatment, analyses of previously treated with intramuscular gold were efficacy and toxicity were also performed on the Correspondence to: Dr D Porter, not excluded; ifchrysotherapy had been stopped subgroups of patients who had never received Centre for because of a lack of effect, or because of serious Rheumatic Diseases, intramuscular gold. Glasgow Royal Infirmary, side effects (proteinuria, leucopenia or thrombo- Castle Street, cytopenia) the patient was assigned to the Glasgow G4 OSF, United Kingdom. sulphasalazine group. If chrysotherapy had Results Accepted for publication been stopped because of any other reason the There were no significant differences between 30 July 1991 patient was randomised. Overall, 40 patients in the two groups in any of the demographic, 462 Porter, Madhok, Hunter, Capell laboratory, or clinical parameters at the start ot heart disease (week 15) and one from congestive treatment. Overall the median age of the cardiac failure secondary to rheumatic heart patients was 56 years (sulphasalazine 55, disease (week 16). Three auranofin and two Ann Rheum Dis: first published as 10.1136/ard.51.4.461 on 1 April 1992. Downloaded from auranofm 57, range 20-82 years), with a median sulphasalazine patients were lost to follow up disease duration of nine years (sulphasalazine before their 48 week assessment because of non- 10, auranofin nine, range 0-42 years). One compliance or moving away from the area. hundred and sixty eight of the 200 patients were There was a significant improvement between women and 72% were seropositive for rheuma- 0 and 12 weeks for all parameters in the toid factor at a titre of 1/64 (Rose Waaler). The sulphasalazine group, and for all except the median dose of sulphasalazine was 2 5 g/day articular index in the auranofin group. Between (range 1 5-4-0 g/day). Twenty one per cent of 0 and 24, and 0 and 48 weeks, all parameters the auranofin group had the dose of their improved significantly in both groups. By 12 auranofm increased to 3 mg three times a day at weeks, however, the sulphasalazine group had a week 12. Eighty two sulphasalazine and 79 significantly lower erythrocyte sedimentation auranofin patients completed 12 weeks of rate (Mann Whitney, p=0-04), platelet count treatment, 76 sulphasalazine and 71 auranofin (p=0-009), and articular index (p=004) (table patients completed 24 weeks of treatment, and 1 and fig 1). There was a significantly larger 63 sulphasalazine and 50 auranofin patients reduction in erythrocyte sedimentation rate and continued treatment for more than 48 weeks. C reactive protein in the sulphasalazine group Two auranofin patients died, one from ischaemic between 0 and 12 weeks compared with the Table I Median (range) ofallparameters at weeks 0, 12, 24, and 48 Parameter Drug treatment Week 0 Week 12 Week 24 Week 48 Erythrocyte sedimentation Sulphasalazinet 51(2-136) 28 (1-124)" 24(3-133)"' 30(1-128)-' rate (mm/h) Auranofinf 52(2-150) 36 (2-138)* 30 (4-136)*' 29(3-110)' Mann-Whitney NS p=0-04 NS NS C reactive protein (mg/I) Sulphasalazine 40(10-170) 17 (10-171) ' 11 (7-205)* 17 (8-100):' Auranofin 37 (10-173) 20 (10-182):' 16 (10-135) 17 (3-245):' Mann-Whitney NS NS NS NS Platelets (x10'/1) Sulphasalazine 415(203-739) 336(178-869)'' 333(171-804)"t 324 (155-624):' Auranofin 427(116-924) 385 (158-890):' 358 (135-756)* 364 (178-709) ':' Mann-Whitney NS p=0 009 NS NS Articular index Sulphasalazine 11 (0-45) 8 (0-48)'' 5 (0-38) 6 (0-37) b Auranofin 14 (0-44) 12 (049) 6 (0-39) 3 (0-34) " Mann-Whitney NS p=0-04 NS NS Early morning stiffness Sulphasalazine 90(0-720) 60 (0-720);' 30 (0-720)" 30 (0-720) g 8 Auranofin 120(0-720) 60(0-720)' 15 (0-720)k 15(0-720) Mann-Whitney NS NS NS NS http://ard.bmj.com/ Pain score Sulphasalazine 55(0-100) 40 (0-1I00): t 35 (0-100):'* 43 (0-100)*' Auranofm 64(0-100) 50(0-100)' 45(0-100)" 33 (0-100)*' Mann-Whitney NS NS NS NS Within groups paired Wilcoxon *p<0 05, **p<00001. tSulphasalazine: week 0, n= 100; week 12, n=82; week 24, n=76; week 48, n=63. tAuranofin: week 0, n=100; week 12, n=79; week 24, n=71; week 48, n=50. Figure I Median erythrocyte sedimentation a- Sulphasalazine on September 28, 2021 by guest. Protected copyright. rate (ESR), C reactive 60 - ---0---- Auranofin protein (CRP), platelet 60- count, and articular index at 50 - weeks 0, 12, 24, and 48. 50 - I 40 - E E 40- 30 - E c0 q~~ ~ ~ ~ ~ --------- (n 20 - w 30' *p = 0 04 10 - zu I I u- l * I. 0 12 24 36 48 0 12 24 36 48 16 - 500 14 - 0o a 450- x 12 - Q O." 10 x ._C * 400- 8- a \ . ... .u 0 * =0-------I-- U 6 -0\.: 350- 4- 300- 2 - *p = 0.04 *p = 0-009 0 1 I I I I 250 0 12 24 36 48 0 12 24 36 48 Weeks Weeks>--~~~~. Use ofsulphasalazine and auranofin in RA 463 Figure 2 Mean change in erythrocyte sedimentation 0 Sulphasalazine rate (ESR), C reactive ----o--- Auranofin protein (CRP), platelet 10 I 10' Ann Rheum Dis: first published as 10.1136/ard.51.4.461 on 1 April 1992.
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