Adalimumab is a human anti-TNF-a monoclonal antibody. It is administered subcutaneously, 40 mg every other week. It currently is approved for use in RA and in PsA. It was first shown effective for PsA in an open trial of 15 patients (Ritchlin et al. 2004). In a larger placebo controlled trial (n = 313) in PsA, in which 50% of patients were on background MTX, 58 % of the treatment group and 14% of the placebo group (p <0.001) showed an ACR 20 response (Fig. 10.6a) at 3 months, the primary endpoint. Initial response in skin was rapid (as early as 2 weeks) and significant. As in the studies of the other TNF-a inhibitors, concomitant use of MTX did not have an effect on efficacy. At 6 months, PASI 50/ 75/90 responses were 75 %, 59 %, and 42 % in the adalimumab group and 12%, 1%, and 0% in the placebo group, respectively (p <0.001) (Fig. 10.6b) (Mease et al.
ACR20 Response 58
PASI 75 fcespunst
Phase H] trill] of Infliximab in Ps/PsA.
Patients =200 randomized to inlliximab 5 mg/kg at baseline and weeks 2, 6 and 14 during the placebo-controlled phase. Infliximab ■ Placebo E
Background DMAKDs. nonsteroidals and prednisone < 1(J nig allowed.
it) Primary outcome: ACR20, Week 14: 58% patients on infliximab group vs 11% placebo group
(p:0.001). 100 placebo. 100 infliximab, b) PASI 75 scores showed an improvement in tlie infli\ini,ib group, al 24 weeks with 'i t"0 vs 2% (pcO.OOl). 87 placebo, 83 infliximab.
Fig. 10.5. Phase 3 Trial of Infliximab in Ps/PsA (Antoni et al. 2005)
10.9 Other Biologic Agents 105
Fig. 10.6. Phase 3 Trial of Adalimumab in PsA (Mease 2005)
ACR2C Response se
PASI 7S Response
Total Charp Scare
PASI 7S Response
Phase III trinI of Adnlimumub in PsA.
Patients =313 randomized to adalimumab, 40 mg qowk vs. placebo Adalimumab ■ Placebo □ Background MTX. nonsteroidals, and prednisone < 10 mg allowed.
a) Primary outcome: ACR20. Week 12: 58% palienls on adalimumab showed improvement group vs 14% of placebo group (p<0.001). 162placcbo, 151 adalimumab.
b) PASI 75 response in adalimumab group was 59% vs 1% in placebo at week 24 (p<0.001).69 placebo, 69 adalimumab.
c) Total Sharp score at week 24 showed the adalimumab group had less joint destruction than the non-adalimumab (p<0 001). 161 placebo. 150 adalimumab.
2005). Significant improvements in measures of physical function, quality of life and fatigue were demonstrated in the treatment group. Radiographic progression of disease was significantly inhibited by adalimu-mab, again showing no progression of structural damage in the treatment group (Mease et al. 2005) (Fig. 10.6c). A second smaller phase III study confirmed efficacy in multiple PsA domains (Genovese et al. 2005).
Several other anti-TNF- agents are in various phases of development for PsA, including a human monoclonal antibody for subcutaneous administration (golimumab), a PEG-ylated Fab fragment of a monoclonal antibody (certolizumab pegol), and even oral agents that have TNF- inhibiting capability.
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