Using ‘number needed to treat’ to help conceptualize the magnitude of benefit and risk of tumour necrosis factor-α inhibitors for patients with severe psoriasis

Abstract

All three of the TNFalpha antagonists have remarkable efficacy in patients with severe psoriasis. The risks of serious adverse events are relatively rare and comparable to the risks patients take on a regular basis such as driving a car. For many patients with severe psoriasis, the benefits of TNFalpha inhibitors may greatly outweigh the risks.

Long-term efficacy and safety of adalimumab in patients with moderate to severe psoriasis treated continuously over 3 years: Results from an open-label extension study for patients from REVEAL

“…AE rates were similar to those observed previously with adalimumab in psoriasis, with rates of serious infection and other AE of interest being generally stable over time. These findings expand understanding of the benefit-risk profile of adalimumab therapy for psoriasis [22][23][24][25] by showing that it remained favorable during more than 3 years of continuous therapy.…”

“…10 REVEAL is the largest placebo-controlled trial for psoriasis with adalimumab, a fully human, monoclonal antietumor necrosis factor antibody. The REVEAL study design had 3 periodseperiod A (weeks 0-16), period B (weeks [16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33], and period C (weeks 33-52) eand permitted only patients with at least a PASI 75 response at the end of one period to continue into the next. 13 At week 16, PASI 75 responses were observed in 71% of patients treated with adalimumab versus 7% with placebo.…”

British Association of Dermatologists’ guidelines for biologic interventions for psoriasis 2009

“…This led to careful selection pretreatment and monitoring and greatly reduced the incidence in those complying with pretreatment testing and prophylaxis, although adherence to guidelines was poor 108 . The risk of tuberculosis may be greater with the monoclonal antibodies (infliximab and adalimumab) as compared with etanercept with incidences of tuberculosis in patients with RA reported to the BSRBR of 39 per 100 000 patient‐years for etanercept, 103 per 100 000 patient‐years for infliximab and 171 per 100 000 patient‐years for adalimumab 109,110 . Even when latent tuberculosis is identified and treated prior to TNF antagonist therapy, patients may develop clinical evidence of infection.…”

“…In the short term, the monoclonal antibodies (infliximab and adalimumab) have a quicker onset of action, and are more effective than etanercept, although by 1 year the proportion of patients maintaining a PASI 75 may be comparable (Table 2). With respect to safety, systematic review of RCT data from short‐term studies suggests that the risk of adverse events may be slightly higher with infliximab compared with etanercept 101,102 and adalimumab 101 while registry data indicate that risks of reactivation of tuberculosis and herpes zoster may be greater with adalimumab and infliximab as compared with etanercept 103,109,110 …”

What’s new in psoriasis? Analysis of the clinical significance of new guidelines and systematic reviews on psoriasis published in 2008 and 2009

“…Dharamsi et al. 11 addressed the risk–benefit ratio of anti‐tumour necrosis factor (anti‐TNF) treatment to aid pretreatment counselling of patients with psoriasis. They compared the number needed to harm by serious adverse events (AEs) from anti‐TNF drugs (limited to tuberculosis, lymphoma and demyelinating disease; ranging from 380 treated patients to 360 000 treated patients per year) with the risk of death from a car accident.…”