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High Toxicity Found To Occur During Infliximab Treatment of Refractory Psoriatic Arthritis

Infliximab has demonstrated efficacy in the treatment of psoriasis, a lesser benefit in refractory psoriatic arthritis (PsA), and a high discontinuation rate due to toxicity among PsA patients with active skin and joint disease, according to researchers at Toronto Western Hospital, Canada.

PsA is an inflammatory arthritis that is associated with psoriasis and recognised as a progressively deforming disease with significant morbidity. In previous studies, infliximab effectively treated skin and joints in PsA patients, as well as led to the histological restoration of normal skin in cases of severe psoriasis.

To evaluate infliximab efficacy and toxicity in patients with treatment resistant PsA, Marie Feletar, MBBS, and colleagues studied 16 PsA patients with 6 or more actively inflamed joints and who previously failed to respond to at least 2 disease modifying antirheumatic drugs (DMARDs).

All study participants had previously received methotrexate, and 11 patients continued that treatment for the study duration. Infliximab (5 mg/kg) was administered by intravenous infusion over period of 2 hours at weeks 0, 2, 6, and 14, with subsequent treatment intervals determined by individual response.

Clinical and laboratory measures included actively inflamed joint count (AJC), swollen joint count (SJC), Psoriasis Area and Severity Index (PASI), Health Assessment Questionnaire (HAQ), and Medical Outcome Survey Short Form-36 (SF-36). The 2 primary outcomes were defined as a 30% or more reduction in AJC and PASI.

Results showed that the AJC was not significantly improved at any time. The PASI improved significantly at weeks 14 (P = .001) and 30 (P = .002), and the SJC showed a significant improvement at week 54 (P = .01). C reactive protein was significantly reduced at week 30.

A total of 6 patients did not complete infliximab treatment, with a mean time to discontinuation of 24.5 weeks. Reasons for discontinuation included liver toxicity (3 patients), severe allergic reaction (1 patient), lack of efficacy and allergic reaction (1 patient), and lack of efficacy alone (1 patient).

Additionally, 6 patients became positive for anti-dsDNA during the study, without clinical features of a connective tissue disease. Of serious adverse events, 3 patients experienced urticaria, 1 had thrombocytopaenia, 2 had lower gastrointestinal bleeding, 2 had severe diarrhoea, and 6 had serious infections (6 patients).

"It must be noted that highly refractory disease, with significant joint damage and a high degree of past DMARD use, distinguishes our cohort from others in open label reports to date and indeed may have contributed to our poorer results in comparison with these other groups," the investigators said.

Infliximab for the study was provided by Schering Canada.

Ann Rheum Dis 2004 Feb;63:2:156-61. "Treatment of refractory psoriatic arthritis with infliximab: a 12 month observational study of 16 patients"

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