Table 1.

Summary of Hydroxyurea safety and efficacy in patients with psoriasis.

Study	Type of Study	Patients	Dosage	Effectiveness	% of Patients achieving “excellent”*improvement	Adverse Events
Leavell and Yarbro 1970	Double- blinded placebo- controlled crossover study	10	500mg BID vs. placebo Treatment period was 8 weeks.	Hydroxyurea treatment period: 9/10 improved per patient and biopsy Placebo treatment period: 9/10 showed NO improvement per patient, dermatologist, and biopsy	90%	No statistically difference in CD4 count, hemoglobin level, platelet count
Rosten 1971	Open-label	12	1–1.5g daily Treatment period was 8 weeks	6/12 had “considerable improvement” 2/12 had no improvement	50%	4/12 side effects (lack of energy, vertigo, mouth ulceration, slight nose bleed)
Hunter et al 1972	Open-label	24	1g daily Treatment period was between 4–40 weeks	16/24 had “very substantial improvement”	67%	Leukocyte decreases in most cases 4 had to d/c treatment because WBC dropped below 4,000
Dahl and Comaish 1972	Open-label	16	Initial: 500mg – 1g daily After 1 – 3 weeks: 1g daily Inadequate response: 1.5 g daily Treatment period was 6–28weeks	7/16 had “excellent response” 7/16 had “good response” 2/16 had “fair response”	44%	Decrease in hemoglobin and WBC levels
Moschella et al 1973	Open-label	60	500mg BID Treatment periods were 4–12 weeks for 18 months.	Initial 6 weeks: 23/60 had >80% of lesions cleared, 15/60 had 60–80% clearance, 6/60 had 30–59% clearance, and 10 patients hat <30 clearance. At 18 months: 50% had >60%	63% had >60% improvement at week 6. 50% have >60% at 18 months	9/60 discontinued treatment because anemia, leukopenia, thrombocytopenia, and drug eruption. 8/60 dropped because of refractoriness to drug
Layton et al 1989	Open-label	85	500mg – 1.5g/day Treatment period was between 3–96 months over 8 year period	60% had complete or almost complete clearance 20% had partial clearance 20% stopped because of inadequate response	60%	11.7% had anemia 11.7% had pancytopenia 7% had leucopenia 18.8% had adverse events that required discontinuation of medication
Kumar et al 2011	Prospective non- randomized case series	31	1–1.5 g daily Treatment period was between 6–136 weeks	At week 12: 43% achieved PASI 75, mean PASI decreased from 17.2 to 4.1 Overall: 26% had PASI90, 55% had PASI 70–90	43% achieved PASI 75 at week 12 Overall 71% achieved PASI 70	Decreased hemoglobin, total leukocyte count, platelets NO nephrotoxity or hepatotoxicity
Ranjan et al 2007	Open-label comparative study	34	Hydroxyurea (2g weekly)** vs. methotrexate (15mg weekly) Dosage was increased if there was <25% reduction of psoriasis Treatment period was 12 weeks	Methotrexate group: 66.6% achieved PASI 75 Hydroxyurea group: 13.3% achieved PASI 75	13% achieved PASI 75	No hematologic toxicities or hepatotoxicity

^*“excellent” is defined as the group of patients in the best efficacy group

^**This is a very low dose of hydroxyurea given over 2 consecutive days in one week.