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A Double-Blind Placebo-Controlled Study of Auranofin in Patients with Psoriatic Arthritis

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A Double-Blind Placebo-Controlled Study of Auranofin in Patients with Psoriatic Arthritis 158 A DOUBLE-BLIND PLACEBO-CONTROLLED STUDY OF AURANOFIN IN PATIENTS WITH PSORIATIC ARTHRITIS SIMON CARETTE, ANDRE1 CALIN, JIM P. McCAFFERTY, BRUCE A. WALLIN, and THE AURANOFIN COOPERATING GROUP Two hundred thirty-eight patients with psoriatic treatment was statistically superior to placebo treat- arthritis were entered into a 6-month, multicenter, ment, according to physician’s global assessment and double-blind trial comparing auranofin and placebo. functional scores. A trend in favor of auranofin treat- Polyarthritis (>5 tender joints) was present in 90% of ment was seen for each of the other disease parameters the patients, and 94% were seronegative. Auranofin studied. Psoriasis worsened in 6 auranofin-treated pa- tients and in 3 placebo-treated patients. The incidence Simon Carette, MD: Le Centre Hospitalier de I’Universitt and nature of other side effects were similar to those Laval, Quebec City, Canada: Andrei Calin, MD: Royal National observed in similar trials of patients with rheumatoid Hospital, Bath, UK; Jim P. McCafferty, BSc: Smith Kline & French arthritis. Our observations suggest that the use of Laboratories, Philadelphia, PA; Bruce A. Wallin, MD: Smith Kline & French Laboratories, Philadelphia, PA; Michael H. Weisman, auranofin in the treatment of psoriatic arthritis is safe, MD: University of California, San Diego; Susan G. Perlman, MD: although its therapeutic advantage over treatment with Northwestern University Medical School, Chicago, 1L; Robert F. nonsteroidal antiinflammatory drugs alone is modest. Willkens, MD: University of Washington, Seattle; Stephen J. Farber, MD: Toledo Clinic, Inc., Toledo, OH: H. Ralph Schuma- cher, Jr., MD: University of Pennsylvania, Philadelphia; Suthin Psoriatic arthritis is an inflammatory erosive Songcharoen, MD: Jackson Arthritis Clinic, Jackson, MS; Ronald joint disease characterized by its association with L. Whisler, MD: Ohio State University Hospital Clinic, Columbus; Gerson C. Bernhard, MD: Rheumatic Disease Center, Milwaukee, psoriasis and by the absence of serologic evidence of WI; Wilbur J. Blechman, MD: N. Miami Beach, FL; Sydney rheumatoid factor. Standard treatment for this condi- Brandwein, MD: Montreal General Hospital, Montreal, Quebec, tion includes salicylates and nonsteroidal antiinflam- Canada; Paul Davis, MD: University of Alberta, Edmonton, Al- berta, Canada; Justus J. Fiechtner, MD: Dakota Medical Center, matory drugs (NSAIDs). When therapeutic response Fargo, ND; Bernard F. Germain, MD: University of South Florida, to this basic regimen is inadequate, disease-modifying Tampa; Robert A. Turner, MD: Bowman Gray School of Medicine, agents, such as antimalarial drugs (1-4), gold salts (5- Winston-Salem, NC; David H. Neustadt, MD: University of Lou- isville, Louisville, KY; Kenneth R. Wilske, MD: The Virginia 7), and methotrexate (8,9), have been used. Mason Clinic, Seattle, WA; Jack Zuckner, MD: Arthritis Consult- The efficacy of parenteral gold in the treatment ants, Inc., St. Louis, MO; Muhammad B. Yunus, MD: University of of psoriatic arthritis has been evaluated in 3 studies (5- Illinois, Peoria; Charles L. Ludivico, MD: Bethlehem, PA; Robert J. R. McKendry, MD: Ottawa General Hospital, Ottawa, Ontario, 7). Although they were not placebo-controlled trials, Canada; Robert M. Bennett, MD: Oregon Health Sciences Univer- they each concluded that injectable gold was effica- sity, Portland; Armin E. Good, MD: Veterans Administration cious in this condition. This apparent success of Hospital, Ann Arbor, MI; Muhammad A. Khan, MD: Metropolitan General Hospital, Cleveland, OH; G. James Morgan, Jr., MD: parenteral gold therapy in psoriatic arthritis, the com- Dartmouth-Hitchcock Medical Center, Hanover, NH; Colin H. parable effects of oral and parenteral gold in treating Wilson, MD: Emory University School of Medicine, Atlanta, GA; seropositive rheumatoid arthritis (1&12), and the Norman 0. Rothermich, MD: The Columbus Medical Center Re- search Foundation, Columbus, OH. lower risk of toxic effects with oral gold strongly Address reprint requests to Simon Carette, MD, Division of suggested that auranofin would be a safe and effective Rheumatology, Le Centre Hospitalier de I’universite Laval, 2705 therapeutic option for treating patients with psoriatic boulevard Laurier, Sainte Foy, Quebec GlV 4G2, Canada. Submitted for publication April 22, 1988; accepted in re- arthritis. vised form September 7, 1988. We designed this multicenter, double-blind Arthritis and Rheumatism, Vol. 32, No. 2 (February 1989) AURANOFIN IN PSORIATIC ARTHRITIS 159 study to evaluate the effectiveness, tolerability, and patients with childbearing potential were admitted if they safety of auranofin (6-9 mg/day) versus placebo in the practiced a clinically accepted method of contraception. treatment of psoriatic arthritis. This study, with its To assess eligibility, each patient was evaluated approximately 4 weeks before administration of the coded enrollment of 238 patients, represents the largest pro- study medication. At this time, a medical history was taken spective, double-blind, placebo-controlledtrial assess- and a physical examination was performed. ing a pharmacologic agent in the treatment of psoriatic Drug administration. The randomization was done by arthritis. computer-generated random numbers for patients at each clinic. Patients within each participating clinic were assigned in blocks of 10, at a 1:l ratio, to receive either auranofin (3 PATIENTS AND METHODS mg/day) or placebo, initially administered in the form of 2 capsulesiday. Uniform criteria were not used to define the Patient selection criteria. Patients eligible for entry lack of clinical improvement. Thus, if after 3 months there into this 6-month double-blind parallel trial comparing aura- was no indication of clinical improvement (according to the nofin and placebo therapy were age 18 years or older, and investigator’s judgment), the investigators had the option of had been diagnosed as having psoriatic arthritis. Patients increasing the dosage of the study medication to 3 capsules/ who had clinically apparent psoriasis or a documented day. The dosage could be reduced at any time because of history of psoriasis of the skin, scalp, or nails and active joint intolerance. disease, which is defined as swelling and/or painkenderness Patients were instructed to maintain their pre-entry in at least 3 joints and a total joint score of at least 10 using dosages of oral steroids (not to exceed 7.5 mg/day of a grading system of 1 (mild) to 3 (severe) for each active prednisone or prednisone equivalent for women and 10 mg/ joint, were entered into the study. The minimum duration of day for men) and/or NSAIDs during the first 3 months of the disease was 3 months. Twenty-seven centers participated. study. Intraarticular injections of steroids were not permit- The study protocol was approved by each institution’s ted. Analgesic agents, such as propoxyphene or acetamino- review board, and each patient signed an informed consent phen, could be taken as needed to treat pain. form prior to entry into the study. Evaluations. Clinical assessments of disease activity All patients had been treated with antiinflammatory were performed at baseline and monthly thereafter (except doses of aspirin or other NSAID, which had not been where noted). Physician’s evaluation. Physician’s assessments in- adequately effective or toxic reactions to these agents had cluded joint counts of tenderness and of swelling, evaluation occurred. All patients were receiving stable doses of aspirin of skin involvement, and a global assessment. For the joint or NSAIDs and had not taken gold, D-penicillamine, leva- tenderness count, 68 peripheral joints were evaluated, and a misole, methotrexate, azathioprine, or antimalarial agents scale of 0-3 was used to score the assessment, as follows: 0 for at least 2 months. The decision not to exclude patients = no tenderness, 1 = positive response on questioning who had been treated with gold was based on the fact that patient, 2 = spontaneous response elicited during examina- parenteral gold and auranofin are basically different drugs tion of joint, and 3 = withdrawal by patient during exami- and that the therapeutic response and/or toxic effects of one nation of joint. For the joint swelling count, 66 joints were compound does not necessarily predict these outcomes with scored, using the following scale: 0 = no swelling, I = the other. Concomitant medications for conditions other detectable synovial thickening without loss of bony con- than psoriatic arthritis were permitted. Concurrent treat- tours, 2 = loss of distinctness of bony contours, and 3 = ment with 8-methoxypsoralen and ultraviolet A irradiation bulging synovial proliferation with cystic characteristics. or treatment within 2 months of the initiation of the study The skin was evaluated at baseline, 3 months, and 6 medication, however, was a reason for exclusion from the months of study. The area of psoriatic involvement, which study. was expressed as a percentage of the total body area, was Patients were excluded if they had any of the follow- recorded, and the “rule of nines” was used to divide body ing conditions: a diagnosis compatible with rheumatoid surface areas (head = 9%, upper extremity = 9% x 2, lower arthritis or evidence of lupus erythematosus, primary anky- extremity = 18% X 2, upper trunk = 18%, lower trunk = losing spondylitis, polyarteritis nodosa, polymyositis/derma- 18%, and genitals = 1%). At each evaluation, the location of tomyositis,
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