Biologics that target pathogenic T cells recommendations

Recommendations for alefacept

  • Indication: moderate to severe psoriasis
  • Dosing: 15 mg every wk given as an intramuscular injection for 12 wk, with a 12-wk follow-up non-treatment period
  • Short-term results:
    • 21% of patients achieved a PASI-75 at wk 14
  • Long-term results:
    • Associated with long remissions in a subset of responders
    • Prior response to alefacept is a likely marker of future treatment response; thus, patients responding to the first course of therapy may be treated long-term with repeated 12-wk courses of alefacept at a minimum of 24-wk intervals
  • Toxicity: excellent safety profile in clinical trials
  • Baseline monitoring: CD4 count
  • Ongoing monitoring: biweekly CD4 count required; hold dose for counts <250
  • Pregnancy category: B
  • Contraindications: HIV infection

Level of Evidence: I Strength of Recommendation: A

Recommendations for efalizumab

  • Indication: moderate to severe psoriasis
  • Dosing: 0.7 mg/kg first dose followed by 1.0 mg/kg/wk subcutaneously
  • Short-term response: 27% of patients achieve a PASI-75 at 3 mo
  • Long-term response: 44%-50% of patients achieved and maintained a PASI-75 response in a 3-y open-label study that only enrolled responders
  • Toxicities:
    • Flu-like symptoms frequently occur initially and generally disappear after the third wk of treatment
    • Thrombocytopenia, hemolytic anemia, pancytopenia, and peripheral demyelination have all been reported
  • Other issues:
    • Small percentage of patients may develop rebound or flare
    • Do not discontinue treatment abruptly unless essential
    • Not effective in psoriatic arthritis; flares and new-onset psoriatic arthritis have been reported in a subset of patients
  • Baseline monitoring: CBC
  • Ongoing monitoring:
  • CBCs monthly for the first 3 mo and at periodic intervals thereafter
  • LFT and a periodic history and physical examination are recommended while on treatment
  • Pregnancy category: C
Level of Evidence: I Strength of Recommendation: A

Navigate section 1 of the psoriasis guideline: Biologics

Citation note

When referencing this guideline in a publication, please use the following citation: Menter A, Gottlieb A, Feldman SR, Van Voorhees AS, Leonardi CL, Gordon KB,et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol. 2008 May;58(5):826-50. 

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