The College of Pharmacy discussed the MSc thesis entitled “Preliminary Study of Short-Term Effectiveness and Safety of Biosimilar Etanercept (Altebrel) in Iraqi Rheumatoid Arthritis Patients” by the student Nourhan Ali Kadhim and the supervisor, Assistant Professor Dr. Fadia Thamir Ahmed, at the Clinical Pharmacy Department.
The study aimed to assess the effectiveness and safety of treatment with Altebrel in Iraqi rheumatoid Arthritis patients during a short-term follow-up period.
The study included 35 adult patients diagnosed with rheumatoid arthritis and eligible for Altebrel treatment who participated in a prospective, real-world study that was conducted at Merjan Teaching Hospital in Hilla, Iraq. Patients were either newly diagnosed or demonstrated an inadequate response to methotrexate. Clinical outcomes, including the disease activity score-28 (DAS28) and erythrocyte sedimentation rate (ESR), the inflammatory biomarkers tumor necrosis factor-alpha (TNF-α) and interleukin-6 (IL-6), laboratory safety profiles, and patient-reported outcomes measurement information system-health assessment questionnaire (PROMIS-HAQ) assessments were recorded at baseline and after 12 weeks of treatment. In addition, to assess the safety of the biosimilar drug, adverse events were studied after 12 weeks of treatment.
The results showed that Altebrel is effective and safe in rheumatoid arthritis patients, as it lowered DAS28, ESR and TNF-α, while IL-6 levels showed no significant decrease. Moreover, the PROMIS-HAQ domains showed meaningful improvements in physical function, pain intensity, anxiety, fatigue, and sleep disturbance. Also, no serious Adverse drug events were recorded.
The study recommended that further research utilizing a larger sample size and longer-term follow-up should be conducted. Furthermore, to use the PROMIS-HAQ scoring as a routine clinical tool in the assessment of rheumatoid arthritis patients.
