The treatment begins with receiving mirikizumab through an intravenous infusion, which means the medication is delivered directly into a vein through a drip. The dosage used is 300 mg.

This initial phase establishes the medication in the body to begin addressing the inflammation in the intestines.

After the initial infusion, the treatment continues with subcutaneous injections, which means injections given under the skin. These injections can be administered at home using pre-filled devices.

Two types of injection devices are available: pre-filled pens and pre-filled syringes. The dosages used are 100 mg or 200 mg, or a combination of 100 mg plus 200 mg, depending on the treatment plan.

The injections are given at regular intervals as determined by the study protocol to maintain consistent medication levels in the body.

At 4 weeks after starting treatment, an evaluation takes place to assess how the body is responding to the medication.

This includes checking for improvements in symptoms such as abdominal pain and bowel frequency, as well as measuring inflammation markers in blood tests.

An ultrasound examination of the intestines may be performed to evaluate changes in inflammation through the bowel wall.

At 8 weeks, another evaluation is conducted to monitor progress.

Similar assessments are performed, including symptom evaluation, blood tests to check inflammation levels, and potentially an ultrasound examination of the intestines.

The frequency and urgency of bowel movements are also assessed.

At 12 weeks (3 months), further evaluation takes place to determine treatment effectiveness.

This includes checking symptom improvement, blood test results for inflammation markers, and potentially an ultrasound examination.

Quality of life and daily functioning are also evaluated through questionnaires.

At 24 weeks (6 months), a comprehensive evaluation is performed, which represents a key milestone in the study.

An MRI scan (magnetic resonance imaging) is performed to assess inflammation through the entire thickness of the bowel wall. The MRI measures a C-score, which is a numerical value indicating the level of inflammation in each affected bowel segment.

The primary goal is to achieve at least a 25% reduction in the C-score in all affected bowel segments compared to the start of the study.

Symptom assessment is conducted, including evaluation of abdominal pain, bowel frequency, and bowel urgency using specific scoring systems.

Blood tests are performed to measure inflammation markers and assess biochemical remission.

Ultrasound examination of the intestines may also be performed.

Quality of life is assessed using the Inflammatory Bowel Disease Questionnaire, and the impact on daily activities is measured using the Inflammatory Bowel Disease Disability Index.

An acceptability scale is used to evaluate satisfaction with the treatment.

Any side effects or adverse events experienced during the treatment are documented.

Treatment with mirikizumab continues with regular subcutaneous injections after the 6-month assessment.

Ongoing monitoring includes regular check-ups to assess symptom control, blood tests, and evaluation of any side effects.

At 18 months, another comprehensive assessment is performed, including evaluation of any structural changes or damage to the bowel using the Lemann Index, which measures long-term bowel damage.

An MRI scan may be repeated to assess the current state of inflammation and healing in the bowel wall.

The study continues with ongoing treatment and monitoring to evaluate the long-term effectiveness and safety of mirikizumab in managing Crohn’s disease.

Regular assessments continue to track symptom control, inflammation levels, quality of life, and any adverse events.

The ability to continue taking the medication without interruption (drug retention) is also monitored throughout the study period.