Spinal Mobility (cm, Mean)
Modified Schober’s teste 4.0 5.0 4.3 4.4 0.75
Chest expansione 3.6 3.7 3.3 3.9 0.04
Tragus to walle 17.3 17.4 16.9 15.7 0.02
Lateral spinal flexione 10.6 11.0 11.4 12.9 0.03
a Measured on a VAS with 0 = “none” and 10 = “severe”
b Bath Ankylosing Spondylitis Functional Index (BASFI), average of 10 questions
c Inflammation, average of last 2 questions on the 6-question BASDAI
d CRP normal range 0-1.0 mg/dL e Spinal mobility normal values: modified Schober’s test: > 4 cm; chest expansion: > 6 cm; tragus to wall:< 15 cm; lateral spinal flexion: > 10 cmThe median improvement from baseline in the general health-related quality-of-lifequestionnaire SF-36 physical component summary score at Week 24 was 10.2 for theinfliximab group vs. 0.8 for the placebo group (P < 0.001). There was no change in the SF-36mental component summary score in either the infliximab group or the placebo group.
Results of this study were similar to those seen in a multicenter double-blind, placebocontrolledstudy of 70 patients with ankylosing spondylitis.
14.6 Psoriatic Arthritis
Safety and efficacy of infliximab were assessed in a multicenter, double-blind, placebocontrolledstudy in 200 adult patients with active psoriatic arthritis despite DMARD orNSAID therapy (≥ 5 swollen joints and ≥ 5 tender joints) with 1 or more of the followingsubtypes: arthritis involving DIP joints (n = 49), arthritis mutilans (n = 3), asymmetricperipheral arthritis (n = 40), polyarticular arthritis (n = 100), and spondylitis with peripheralarthritis (n = 8). Patients also had plaque psoriasis with a qualifying target lesion ≥ 2 cm indiameter. Forty-six percent of patients continued on stable doses of methotrexate(≤ 25 mg/week). During the 24-week double-blind phase, patients received either 5 mg/kginfliximab or placebo at Weeks 0, 2, 6, 14, and 22 (100 patients in each group). At Week 16,
placebo patients with < 10% improvement from baseline in both swollen and tender jointcounts were switched to infliximab induction (early escape). At Week 24, all placebo-treatedpatients crossed over to infliximab induction. Dosing continued for all patients throughWeek 46.
Clinical response
Treatment with infliximab resulted in improvement in signs and symptoms, as assessed bythe ACR criteria, with 58% of infliximab-treated patients achieving ACR 20 at Week 14,compared with 11% of placebo-treated patients (P < 0.001). The response was similarregardless of concomitant use of methotrexate. Improvement was observed as early asWeek 2. At 6 months, the ACR 20/50/70 responses were achieved by 54%, 41%, and 27%,respectively, of patients receiving infliximab compared to 16%, 4%, and 2%, respectively, ofpatients receiving placebo. Similar responses were seen in patients with each of the subtypesof psoriatic arthritis, although few patients were enrolled with the arthritis mutilans andspondylitis with peripheral arthritis subtypes.
Compared to placebo, treatment with infliximab resulted in improvements in the componentsof the ACR response criteria, as well as in dactylitis and enthesopathy (Table 11).
The clinicalresponse was maintained through Week 54. Similar ACR responses were observed in anearlier randomized, placebo-controlled study of 104 psoriatic arthritis patients, and theresponses were maintained through 98 weeks in an open-label extension phase.
Table 11 Components of ACR 20 and percen |
