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7th September 2021
The National Institute for Health and Care Excellence (NICE) has approved the use of the monoclonal antibody Cosentyx (secukinumab) as an option for the treatment of plaque psoriasis in children and young people aged 6 to 17 years of age. It is only recommended where the psoriasis area and severity index (PASI), which is a measure of disease severity, is greater than 10 (meaning moderate to severe disease) and where other systemic therapies have been unsuccessful. The systemic therapies mentioned in the guidance are ciclosporin, methotrexate, as well as phototherapy, although Cosentyx can also be used in cases where any of these treatments are contra-indicated. In addition, NICE has recommended use of Cosentyx only where the manufacturer provides the drug in line with an agreed commercial arrangement.
The outcome of interest when using Cosentyx is the achievement of a PASI75, i.e., a 75% improvement in disease severity, after 12 weeks of treatment. If such an improvement has not occurred, then NICE recommends stopping Cosentyx. A further point in the guideline is that where a clinician considers that secukinumab is the most appropriate therapy, the least expensive option should be used and it has been increasing recognised that there are huge potential and achievable savings for the NHS through the use of biosimilars,
In making its decision, NICE received information on the comparative clinical efficacy of other biologics used in psoriasis including etanercept, adalimumab and ustekinumab. The committee noted from studies that secukinumab was more effective than etanercept, based on a higher proportion of participants achieving a PASI75 and that the efficacy was comparable with ustekinumab. Although there were no direct comparisons of Cosentyx with adalimumab in the paediatric population, a network meta-analysis submitted by the manufacturer, showed that adalimumab was as effective as ustekinumab. Furthermore, there were no differences in safety outcomes for Cosentyx compared with other similar biologics.
Source. NICE 2021
26th July 2021
Rheumatoid arthritis (RA) is an autoimmune disease that causes joint inflammation, pain, stiffness and destruction of articulator bone and cartilage that affects around 51/10,000 people. Treatment involves the use disease-modifying anti-rheumatic agents (DMARDs) but despite this, evidence suggests that patients continue to experience activity limitations and pain, despite reduced levels of inflammation. The persistence of pain has a negative impact on quality of life and leads to fatigue. In fact, it has been suggested that the extent of pain identified by patients at the point of diagnosis can predict the level of fatigue subsequently reported. Hence, a better understanding of the potential predictors of pain early in the disease course, could enable better targeting of pain interventions. In trying to identify the predictors of pain, a team from the Department of Clinical Sciences, Malmo, Lund University, Sweden, turned to data on an inception cohort of patients with RA, recruited between 1995 and 2005, who had been diagnosed with the condition for less than 12 months. A structured examination and data collection programme occurred at inception and then after 6 months, 1, 2 and 5 years. There was no specific treatment protocol and patients were all managed according to standard care. Patient reported outcomes and disease activity measures were collected at each follow-up visit and pain was assessed using a visual analogue scale (VAS), ranging from 0 to 100, with higher scores indicating more severe pain. In addition, a patient global assessment of disease activity (PGA) was included as were measures of swollen joint counts and various biological measures e.g., anti-CCP antibodies. For the purposes of the study, unacceptable pain was defined as a VAS scores > 40.
In total, 232 patients with early rheumatoid arthritis with a mean age of 60.5 years (70.3% female) were included in the analysis but only 179 attended the 5-year follow-up appointment. At inception, the mean VAS pain score was 41.2 and reduced to 32.3 at the first 6-month appointment but remained unchanged during the next five years. The proportion of patients with unacceptable pain scores at inception was 49.1% although this decreased to 30.1% during the first year. However, as with mean VAS scores, the proportion of patients with unacceptable pain did not alter over time. At the two-year follow-up, significant predictors of unacceptable pain included female sex (odds ratio, OR = 2.57, 95% CI 1.27–5.33) and VAS pain scores (OR = 1.56). After 5 years, 34.1% of patients still had unacceptable pain and significant predictors included lower swollen joint counts (OR = 0.71) and anti-CCP antibodies (OR = 0.50).
The authors noted that while RA patients had low inflammatory activity, a third continued to experience pain 5 years later. They concluded that future studies should focus on how to optimise pain management at an early disease stage because this was associated with a great burden over time.
Eberhard A et al. Predictors of unacceptable pain with and without low inflammation over 5 years in early rheumatoid arthritis — an inception cohort study. Arthritis Res Ther 2021