{
  "abstract": "Background and Importance The treatment of moderate-to-severe Crohn’s disease has evolved with the emergence of new therapeutic targets such as risankizumab. Plasma drug concentrations complement data directly related to patient efficacy and safety.Aim and Objectives To estimate the population-based minimum plasma concentration (Cmin) of risankizumab at weeks 12 and 52 and to correlate the degree of attainment of the threshold associated with clinical remission.Material and Methods Retrospective observational study including adult patients diagnosed with Crohn’s disease and treated with risankizumab. The two-compartment model described by Suleiman et al. was implemented using the PKS software by Abbott. Patients receiving risankizumab were selected, and the predicted Cmin at weeks 12 and 52 of treatment was calculated using Bayesian estimation. A threshold associated with clinical remission was set at >60 mcg/mL at week 12 and >10 mcg/mL at week 52, based on the literature reviewed from Suleiman et al., Sequier et al., and Robin et al., as there is no established consensus. The predicted Cmin at week 52 was evaluated using the efficacy data documented in the electronic health records of patients for whom this information was available. Demographic (sex and age), anthropometric (weight), and laboratory (creatinine, faecal calprotectin (FCP), albumin) data were collected from electronic medical records.Results 32 patients were included; 57.9% women, with a median age of 53 years (27–77). The median clinical variables were: weight 70 kg (48–138); FCP 131mg/kg (12–537); and albumin 45 g/L (39–48). At week 12, no patients reached the established threshold, with a median Cmin of 33.2 mcg/mL (25.7–47.7). At week 52, only three patients achieved an adequate maintenance Cmin, with a global median of 6.5 mcg/mL (3.9–11). Of the five patients with follow-up data at week 52, 100% required re-induction due to lack of efficacy. All had subtherapeutic levels at both week 12 and week 52 under the dosing regimen specified in the product label. They are currently on an intensified regimen of risankizumab 360 mg subcutaneously every 6 weeks.Conclusion and Relevance The recommended dosing of risankizumab in patients with Crohn’s disease does not achieve the pharmacokinetic/pharmacodynamic targets established in our study and is associated with a lack of response to the drug.Conflict of Interest No conflict of interest",
  "authors": [
    {
      "affiliations": [
        "Complejo Asistencial De Zamora, Pharmacy, Zamora, Spain"
      ],
      "name": "S Fernandez Cañabate"
    },
    {
      "affiliations": [
        "Complejo Asistencial De Zamora, Pharmacy, Zamora, Spain"
      ],
      "name": "Á Corral Alaejos"
    },
    {
      "affiliations": [
        "Complejo Asistencial De Zamora, Pharmacy, Zamora, Spain"
      ],
      "name": "M Corrales Paz"
    },
    {
      "affiliations": [
        "Complejo Asistencial De Zamora, Pharmacy, Zamora, Spain"
      ],
      "name": "J Jimenez Casaus"
    },
    {
      "affiliations": [
        "Complejo Asistencial De Zamora, Pharmacy, Zamora, Spain"
      ],
      "name": "JS Roldan Gonzalez"
    },
    {
      "affiliations": [
        "Complejo Asistencial De Zamora, Pharmacy, Zamora, Spain"
      ],
      "name": "G Goda Montijano"
    },
    {
      "affiliations": [
        "Complejo Asistencial De Zamora, Pharmacy, Zamora, Spain"
      ],
      "name": "V Martínez Fernández"
    },
    {
      "affiliations": [
        "Complejo Asistencial De Zamora, Pharmacy, Zamora, Spain"
      ],
      "name": "I Gil Navarro"
    },
    {
      "affiliations": [
        "Complejo Asistencial De Zamora, Pharmacy, Zamora, Spain"
      ],
      "name": "C Gil Valiño"
    }
  ],
  "title": "4CPS-002 Importance of individualising isankizumab treatment in patients with Crohn’s disease",
  "uid": "269ad3ba-7da9-5b5f-b60f-d1e6308c1933"
}