Emerging Oral Immunomodulators for the Treatment of Psoriasis: A Review of Phase III Clinical Trials for Apremilast and Tofacitinib.
BACKGROUND
Increased knowledge of the molecular regulatory mechanisms that contribute to the pathogenesis of psoriasis and other inflammatory diseases has created new opportunities for the development of targeted drug therapy for inflammatory conditions. Two new oral medications, apremilast and tofacitinib, have been developed for their immunomodulatory properties, and their potential efficacy in treating psoriasis is being evaluated.


METHODS
We reviewed phase III randomized, placebo-controlled clinical trial results for apremilast and tofacitinib for efficacy and safety in psoriasis.


RESULTS
Psoriasis Area and Severity Index (PASI) 75 after 16 weeks for apremilast was between 28.8% and 33.1%. PASI 75 was 39.5% after 12 weeks on tofacitinib 5 mg, and 63.6% after 12 weeks on tofacitinib 10 mg. Common side effects for both drugs included nasopharyngitis and upper respiratory tract infections. Gastrointestinal disturbance was common for apremilast. Dyslipidemia and infections were more common with tofacitinib than placebo.


CONCLUSIONS
Both new oral medications, apremilast and tofacitinib, appear to be effective in treating psoriasis
Rachel
R
McAndrew
Ethan
E
Levin
John
J
Koo
D000284:Administration, Oral; D017326:Clinical Trials, Phase III as Topic; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use*; D058988:Phosphodiesterase 4 Inhibitors / Q000627:therapeutic use*; D010880:Piperidines / Q000627:therapeutic use*; D047428:Protein Kinase Inhibitors / Q000627:therapeutic use*; D011565:Psoriasis / Q000188:drug therapy*; D011743:Pyrimidines / Q000627:therapeutic use*; D011758:Pyrroles / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D012720:Severity of Illness Index; D013792:Thalidomide / Q000031:analogs & derivatives* / Q000627:therapeutic use
D007155:Immunologic Factors; D058988:Phosphodiesterase 4 Inhibitors; D010880:Piperidines; D047428:Protein Kinase Inhibitors; D011743:Pyrimidines; D011758:Pyrroles; D013792:Thalidomide; C479163:tofacitinib; C505730:apremilast