Sulfasalazine therapy for psoriatic arthritis: a double blind, placebo controlled trial.

OBJECTIVE: Psoriatic arthritis (PsA) is often poorly responsive to 2nd line antirheumatic drug therapy. Sulfasalazine has recently gained wide acceptance in the treatment of rheumatoid arthritis, and beneficial effects have also been noted in ankylosing spondylitis and reactive arthritis. We report a double blind placebo controlled study of sulfasalazine in PsA. METHODS: Twenty-four patients with active PsA were randomized to receive either sulfasalazine (3 g/day) (n = 10) or placebo (n = 14) for 8 weeks, in a double blind manner, followed by an 8 week open label crossover phase for nonresponding placebo patients. RESULTS: Compared with placebo controls, sulfasalazine treated patients were significantly improved at Weeks 4 and 8 with respect to physician (p < 0.01) and patient (p < 0.05) global assessments. Duration of morning stiffness was significantly decreased at Week 8 (p < 0.01). Clinical variables of disease activity returned to baseline after a 4 week drug washout period in 5 evaluable patients. Six patients in the placebo group crossed over to an 8 week open label phase and demonstrated significant improvements in joint scores, 50 ft walking time, and global patient assessment. Sulfasalazine treated patients also showed significant improvements in cutaneous involvement. CONCLUSION: Sulfasalazine was effective in PsA, with efficacy observed as early as the 4th week of treatment. Longterm studies are needed to determine whether such therapy can modify disease outcome.

Cyclosporine for plaque-type psoriasis. Results of a multidose, double-blind trial.

BACKGROUND: Severe plaque-type psoriasis has been successfully treated with orally administered cyclosporine, but there has been no comparative, controlled evaluation of various dosages and their efficacy and side effects. METHODS: In a 16-week, double-blind trial, we randomly assigned 85 patients with severe psoriasis to receive 3, 5, or 7.5 mg of cyclosporine per kilogram of body weight per day or a placebo consisting of the vehicle for the drug. After eight weeks the dose could be adjusted to improve safety or efficacy while maintaining blinding. RESULTS: The psoriasis improved in a dose-dependent fashion. After eight weeks of fixed-dose therapy, 36, 65, and 80 percent of the patients receiving 3, 5, and 7.5 mg of cyclosporine per kilogram per day, respectively, were rated as being clear or almost clear of psoriasis; each group had significant improvement (P less than 0.0001) as compared with the group receiving vehicle, in which none of the patients were rated as clear or almost clear. The patients who received 5 mg per kilogram were the least likely to require dosage adjustments because of side effects or a lack of efficacy. The glomerular filtration rate, measured in a subgroup of 34 patients receiving cyclosporine, decreased by a median of 16 percent. Higher doses of cyclosporine had greater adverse effects on systolic blood pressure, glomerular filtration rate, and serum levels of creatinine, uric acid, bilirubin, and cholesterol. Delayed-type hypersensitivity reactions to skin-test antigens were reduced by cyclosporine administration. Cyclosporine appears to become concentrated in skin. CONCLUSIONS: Cyclosporine therapy leads to a rapid and thorough clearing of psoriasis; an initial dose of 5 mg per kilogram per day seems to be appropriate. However, the safety of cyclosporine for the long-term treatment of psoriasis remains to be determined.

Keratoses in patients with psoriasis: a prospective study in fifty-two inpatients.

Twenty-eight of 52 consecutive psoriasis inpatients admitted for therapy with the modified Goeckerman regimen had discrete, gray-white, asymptomatic, keratotic lesions approximately 4 mm in diameter at discharge from the hospital. In 18 of these 28 patients no keratoses were noted on admission. In 9 of 10 patients who had keratoses at admission, there was an increase in number at discharge. All patients with keratoses on admission had multiple, closely spaced previous admissions. No age, sex, or skin type predominance was evident in the group with keratoses compared with the remainder of the group (24 patients) who did not have keratoses. The development of keratoses was not related to the type or duration of psoriasis. Statistically significant predisposing factors were the number of UVB and PUVA treatments and the number of inpatient admissions. Fifty-two percent were located on the extremities, 33% on the trunk, and 15% on the face, head, and neck. Histologic examination of these lesions suggested that they may be a variant of seborrheic keratoses. We have not seen these lesions on patients receiving UVB, PUVA, or tar therapy for other diseases. This raises the possibility that these lesions may be unique to psoriasis and most likely are related to long-term therapy.

Sulfasalazine improves psoriasis. A double-blind analysis.

In an 8-week double-blind trial of sulfasalazine for the treatment of moderate-to-severe psoriasis, 23 and 27 patients received the active and placebo tablets, respectively. At the end of the double-blind phase, there were 17 assessable patients receiving sulfasalazine; 7 (41%) had marked improvement, 7 (41%) had moderate improvement, and 3 (18%) demonstrated minimal change. Only 1 patient receiving placebo demonstrated moderate improvement, whereas the rest had minimal improvement or worsening of psoriasis. When the randomization code was broken, patients receiving sulfasalazine were allowed to continue therapy for an additional 4 weeks in an open manner, while those using placebo left the study. Six of 23 patients discontinued sulfasalazine therapy during the double-blind phase because of side effects, 4 due to the development of a cutaneous eruption and 2 due to nausea. Fourteen of 17 patients, who were assessable at the end of the 8-week double-blind phase, completed the additional 4 weeks of sulfasalazine therapy. Of these 14 patients, marked improvement occurred in 8 (57%), moderate improvement in 2 (14%), and minimal improvement in 4 (29%), compared with pretherapy. The low incidence of severe side effects makes sulfasalazine a consideration for oral therapy in patients whose disease severity does not justify use of methotrexate, etretinate, or psoralen plus UV-A, but whose disease severity is too widespread for safe and practical use of topical corticosteroids.

Sulfasalazine: a potential psoriasis therapy?

In an open study, 32 patients with moderate to severe stable plaque psoriasis were treated with sulfasalazine, 3 gm daily for 8 weeks. Twenty-four patients completed the study, and 19 had modest to marked improvement or clearing. If confirmed by a double-blind study, sulfasalazine could become an alternative therapy in some patients with moderate to severe psoriasis.