Adalimumab dose increase more effective in obese hidradenitis suppurativa patients

27th June 2023

A higher dose of adalimumab is likely to be more effective for obese patients with hidradenitis suppurativa, according to the findings of a small trial.

Adalimumab (ADA) is one of only two biologic therapies, together with secukinumab, approved by the EMA for the management of hidradenitis suppurativa (HS). However, adalimumab dosing is not weight-based and in two phase 3 trials, just over half of the patients assigned to adalimumab 40 mg/week (ADA40) achieved a clinical response.

Given that patients with HS are four times more likely to be obese compared to the general population, there might be an advantage of using a higher ADA dose in HS patients who are either overweight or obese.

In the current study, published in the Journal of Drugs in Dermatology, a team of US researchers evaluated the effectiveness of adalimumab 80 mg/week (ADA80) versus 40 mg, in overweight and obese patients with moderate to severe HS. The team included patients with a body mass index greater than 25 and who were refractory to treatment with ADA40. A dose of 80 mg was administered for at least three months and improvements were assessed using the HS-Physician Global Assessment.

Response to adalimumab 80 mg in HS

A total of eight patients with a mean age of 37 years (six females) and with a median body mass index of 36.6 were included in the study and were followed for a median of 13.2 months on ADA80.

Patients experienced a greater improvement in the HS-Physician Global Assessment with ADA80 compared to ADA40 (p = 0.01). In addition, all five patients who had their lesion counts documented achieved a HS clinical response, and all eight patients reported improvements in pain, drainage, lesions and the frequency of disease flares.

While acknowledging the limitations from a small sample size, the researchers suggested that their data indicates a benefit increasing the dose of adalimumab in overweight and obese patients with HS.

Earlier this year, a phase 3 trial found bimekizumab to be an effective treatment for patients with hidradenitis suppurativa.

Monitoring adalimumab levels valuable for assessing remission in children with Crohn’s disease

9th June 2021

Adalimumab is effective for children with Crohn’s disease but little is known about the impact of therapeutic monitoring on clinical outcomes.

The clinical symptoms of Crohn’s disease (CD) are similar in adults and children although there is evidence that cases of paediatric CD are on the rise, with one study estimating that the highest incidence, at 23 per 100,000 person-years occurred in Europe.

Endoscopic evidence of mucosal healing is a valuable therapeutic goal that decreases the risk of disease relapse although little is known about the association between mucosal healing and therapeutic levels of biological treatments such as adalimumab.

This prompted a team from the Department of Paediatrics, Samsung Medical Centre, Korea, to examine the relationship between therapeutic drug monitoring of adalimumab and mucosal healing and clinical remission in paediatric patients with CD.

The team prospectively recruited paediatric patients with CD receiving adalimumab maintenance therapy and who underwent routine endoscopic evaluation of mucosal healing and therapeutic drug monitoring. Monitoring assessments were made at four months and then at years one, two and three.

Findings

In total, 31 children with a mean age of 14.8 years (74% male) were included in the analysis. After one year of treatment, 26 (83.9%) had achieved clinical remission and 17 (54.8%) had complete mucosal healing.

The mean adalimumab trough levels were higher in patients who had achieved remission compared to those with active disease (7.6 mcg/ml vs 5.1 mcg/ml, remission vs active disease).

Similarly, trough levels of adalimumab were significantly higher in those who achieved mucosal healing after one year (14.2 mcg/ml vs 7.8mcg/ml, mucosal healing vs non-healed, p = 0.03).

Although only 23 children were evaluated after 3 years, adalimumab trough levels remained above 10 mcg/ml and a similar proportion of children maintained mucosal healing (64.3%) and clinical remission (92.9%).

Using receiver operating curves, authors calculated that the optimal cut-off adalimumab trough levels to achieve mucosal healing was 8.18 mcg/ml.

In discussing their findings, the authors commented on the results demonstrated that mucosal healing rates increased when adalimumab was used over the longer term and that the drug maintained its efficacy.

They concluded that there was merit in using therapeutic drug monitoring to guide proactive optimisation of drug levels to achieve the goal of mucosal healing.

Citation
Kim MJ et al. Therapeutic Drug Monitoring of Adalimumab During Long-term Follow-up in Paediatric Patients with Crohn Disease. JPGN 2021;72:870-6.