Therapy change necessary at 12 weeks if methotrexate has not improved psoriasis
MedWire News: Research suggests that psoriasis patients treated with escalating doses of methotrxate - as specified by the CHAMPION study - should switch treatment if their condition has not improved by 12 weeks.
Participants of CHAMPION - a phase III trial comparing adalimumab with methotrexate and placebo for chronic plaque psoriasis - received step-up dosing of methotrexate from 15 mg to a maximum of 25 mg during a 16-week period, with the aim of reaching a Psoriasis Area and Severity Index (PASI) score of 75.
Eric Sasso (Abbott Laboratories, Illinois, USA) and colleagues report that nearly all patients who ultimately achieved a PASI 75 response had achieved PASI 50 by week 8 (for those who received no more than 15 mg) or by week 12 (for those whose dose was increased to 20 mg).
In addition, for PASI 50 nonresponders at week 12, increasing the methotrexate dose to 25 mg "provided little additional efficacy," write Sasso et al in the British Journal of Dermatology.
In all, 103 methotrexate-treated patients from CHAMPION, with moderate to severe chronic, stable plaque psoriasis were included in the analysis. Participants were grouped according to their response to treatment; early responders (ER) achieved PASI 50 or above at week 8 and remained on 15 mg treatment; late responders (LR) had not achieved PASI 50 at week 8, at which point their dose increased to 20 mg and they achieved PASI 50 or above by week 12; and late nonresponders (LN) did not achieve PASI 50 at week 12, despite a dose increase to 25 mg at this point.
The mean percentage improvement in PASI score from baseline was greatest for ERs, at 79.9%, compared with 69.7% in LRs and 24.8% in LNs. The corresponding PASI 75 response rates at week 16 of the study were 70.0%, 40.9%, and 4.9%, respectively.
The majority of PASI improvement for the ER and LR groups occurred in the first 8 and 12 weeks of the study, write the study authors, and "consistent with the group definition," they add, the LN group showed relatively little mean improvement after a dosage increase to 20 mg at week 8, and to 25 mg at week 12.
Similar to PASI scores, patients' Dermatology Life Quality Index (DLQI) scores were most improved for all three groups during the first 12 weeks of treatment. Furthermore, mean overall improvements in DLQI from baseline were higher in the ER and LR groups compared with the LN group, at 77.1% and 69.3% compared with 28.4%, and almost no additional improvement was noted in LN patients after week 12.
"Thus, a treatment strategy that identifies LNs at week 12 and promptly switches them to another therapy may be in their best interest, both for skin disease and for quality of life," conclude Sasso and co-investigators.
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By Sarah Guy