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Safety and efficacy of ABT-874, a fully human interleukin 12/23 monoclonal antibody, in the treatment of moderate to severe chronic plaque psoriasis: results of a randomized, placebo-controlled, phase 2 trial.

AbstractOBJECTIVE:
To investigate the efficacy and safety of ABT-874, an interleukin 12/23 monoclonal antibody, in psoriasis.
DESIGN:
Phase 2, 12-week, multicenter, randomized, double-blind, placebo-controlled trial.
SETTING:
Outpatient dermatology clinics. Patients One hundred eighty patients with clinically stable moderate to severe chronic plaque psoriasis. Interventions Patients were randomized in groups of 30 to receive 1 of 6 treatments with ABT-874 provided as a subcutaneous injection: one 200-mg dose at week 0; 100 mg every other week for 12 weeks; 200 mg weekly for 4 weeks; 200 mg every other week for 12 weeks; 200 mg weekly for 12 weeks; or placebo. Main Outcome Measure At least a 75% reduction in the Psoriasis Area and Severity Index.
RESULTS:
The percentage of patients achieving a 75% reduction in the Psoriasis Area and Severity Index at week 12 was statistically significantly greater in all of the ABT-874 treatment groups than in the placebo group (200 mg once, 63% [19 of 30]; 100 mg every other week for 12 weeks, 93% [28 of 30]; 200 mg weekly for 4 weeks, 90% [27 of 30]; 200 mg every other week for 12 weeks, 93% [28 of 30]; 200 mg weekly for 12 weeks, 90% [27 of 30]; placebo, 3% [1 of 30]; P < .001). Treatment with ABT-874 was well tolerated. The most common adverse event was injection-site reaction, and the most common infectious adverse events were nasopharyngitis and upper respiratory tract infection. There were no serious infectious adverse events.
CONCLUSIONS:
ABT-874, an interleukin 12/23 monoclonal antibody, was highly effective and well tolerated in the treatment of psoriasis. Longer-term studies are required to confirm these findings.
AuthorsAlexa B Kimball, Kenneth B Gordon, Richard G Langley, Alan Menter, Elliot K Chartash, Joaquin Valdes, ABT-874 Psoriasis Study Investigators
JournalArchives of dermatology (Arch Dermatol) Vol. 144 Issue 2 Pg. 200-7 (Feb 2008) ISSN: 1538-3652 [Electronic] United States
PMID18283176 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Antibodies, Monoclonal
  • Interleukin-23
  • Interleukin-12
Topics
  • Adult
  • Antibodies, Monoclonal (administration & dosage, adverse effects, therapeutic use)
  • Chronic Disease
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Female
  • Humans
  • Interleukin-12 (immunology)
  • Interleukin-23 (immunology)
  • Male
  • Middle Aged
  • Nasopharyngitis (chemically induced)
  • Psoriasis (drug therapy, pathology, physiopathology)
  • Respiratory Tract Infections (chemically induced)
  • Severity of Illness Index
  • Treatment Outcome

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