Transitioning patients from efalizumab to alternative psoriasis therapies: findings from an open-label, multicenter, Phase IIIb study.

Abstract

BACKGROUND:

Rebound in psoriasis is, by definition, a rapid worsening of disease following the discontinuation of therapy for psoriasis; it occurs following the abrupt discontinuation of many therapies. To prevent rebound on discontinuation of efalizumab, this study evaluated the effectiveness of transitioning patients to an alternative psoriasis therapy.

METHODS:

Patients (n = 130) received subcutaneous efalizumab 1 mg/kg/week for 12 weeks. Efalizumab was discontinued at 12 weeks; patients were evaluated for improvement from baseline in the Psoriasis Area and Severity Index (PASI) and a 12-week transition period was begun. Patients who achieved PASI improvement of 75% or more (PASI-75) at week 12 of efalizumab treatment were observed during the transition period and treated only if psoriasis recurred. Patients who did not attain PASI-75 at week 12 of efalizumab treatment were immediately transitioned to an alternative psoriasis therapy at the physician's discretion. All patients were evaluated for signs of rebound following efalizumab discontinuation.

RESULTS:

Rebound was not observed in any PASI-75 responder (n = 46). Rebound was observed in two of 32 patients who achieved between PASI-50 and PASI-75, and was more common in nonresponders (14/49). Rebound was observed in none of the eight patients treated with cyclosporine and in two of the 12 patients treated with methotrexate during the transition period.

CONCLUSIONS:

These results suggest that efalizumab-responsive patients are less likely to experience rebound than nonresponders and may not require treatment until disease recurrence following efalizumab discontinuation. Efalizumab nonresponders are at higher risk of developing rebound and thus should be considered for transition to an appropriate psoriasis therapy immediately following efalizumab discontinuation.

• Authors: Alan Menter, Tiffani K Hamilton, Darryl P Toth, Hoi M Leung, Graham Wetherill, Brian Hennessey, Marvin Garovoy, Paul Kwon, David M Pariser, Efalizumab Study Group
• Journal: International journal of dermatology (Int J Dermatol) Vol. 46 Issue 6 Pg. 637-48 (Jun 2007) ISSN: 0011-9059 [Print] England
• PMID: 17550570 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Monoclonal
• Antibodies, Monoclonal, Humanized
• Dermatologic Agents
• efalizumab

Topics

• Adolescent
• Adult
• Aged
• Antibodies, Monoclonal (adverse effects, therapeutic use)
• Antibodies, Monoclonal, Humanized
• Dermatologic Agents (adverse effects, therapeutic use)
• Drug Administration Schedule
• Female
• Humans
• Injections, Subcutaneous
• Male
• Middle Aged
• PUVA Therapy
• Psoriasis (drug therapy, immunology, pathology)
• Secondary Prevention
• Severity of Illness Index
• Treatment Outcome