THE ROLE OF A SPECIALIST PHARMACIST IN THE MANAGEMENT OF ADALIMUMAB IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE

Objective: The management of inflammatory bowel disease (IBD) patients on complex medications such as biologic disease-modifying anti-rheumatic drugs (DMARD) requires close supervision. At East Sussex NHS Healthcare Trust (ESHT), the multi-disciplinary team (MDT) already looking after these patients could benefit from the additional knowledge and support from a specialist pharmacist (SP). Methods: To assess if the MDT could benefit from an SP, all IBD patients on the DMARD adalimumab were identified. The patient records were screened for patient demographic data, clinical assessment and investigations, treatment, and follow-up clinics. Results: 162 patients at ESHT were identified as being on adalimumab treatment for either Crohn’s Disease (77%) or Ulcerative Colitis (23%). Disease activity scores, a clinical measure of IBD severity, were infrequently recorded (1%) on patient letters. Evidence of a biologic screen, a series of investigations to ensure safety in a biologic treatment, was only evident in one-third of patients. Clinic review of patients recently started on adalimumab and annual review of stable patients occurred 43% and 26% respectively. Conclusion: The results indicate that there is a need for an additional member to support the IBD MDT in managing this cohort of patients. An SP is uniquely positioned to fill this gap. They have extensive knowledge in drug indication, therapeutic drug monitoring, and side-effect profiles. Similar studies have been identified that support SP in this role.

The risk of tuberculosis infection in 410 Saudipatients receiving adalimumab therapy

BACKGROUND: Adalimumab is a fully humanized monoclonal antibody inhibitor of tumor necrosis factor-a used to treat various autoimmune disorders. Adalimumab poses a risk for tuberculosis (TB) infection, especially in countries where TB is endemic. OBJECTIVE: Determine the rate of TB infection after adalimumab therapy in Saudi Arabia. DESIGN: Medical record review. SETTINGS: Tertiary care center in Riyadh. PATIENTS AND METHODS: Demographic and clinical data were retrieved from the electronic healthcare records of all patients who received adalimumab treatment from 2015 to 2019. MAIN OUTCOME MEASURES: Occurrence of TB after adalimumab therapy. SAMPLE SIZE: 410 patients (median ([QR] age, 37 [28], range 4–81 years), 40% males RESULTS: Rheumatoid arthritis was the most frequent indication (n=153, 37%). The patients were followed for a mean of 36 (8.9) months. No case of TB infection or reactivation was observed. An inter-feron-gamma release assay (IGRA) was requested in 353/391 (90.3%) patients, prior to initiating therapy. The IGRA was positive in 26 cases (6.6%). The IGRA-positive patients received isoniazid prophylactically. Bacterial infectious complications of adalimumab therapy occurred in 12 (2.9%) patients. Urinary tract infection was the most frequent complication (culture requested in 48 patients, positive in 8). CONCLUSION: Adalimumab treatment was not associated with a risk of TB disease or TB reactivation in our cohort over the follow-up observation period. No TB reactivation occurred with adalimumab therapy when TB prophylaxis was used. The positive IGRA rate in patients on adalimumab treatment was low (7%). LIMITATIONS: Single center and one geographical area in Saudi Arabia. CONFLICT OF INTEREST: None.

A TNFα-gátló szemészeti alkalmazása: adalimumabkezelés uveitisben

Összefoglaló. Bevezetés: Az adalimumab egy TNFα-gátló monoklonális antitest; számos indikációja közül a nem fertőzéses eredetű intermedier, posterior és panuveitisek kezelésében is általánosan alkalmazható készítmény. Célkitűzés: A felnőttkori nem fertőzéses eredetű uveitis miatt adalimumabkezelést kapó betegekkel szerzett tapasztalataink összefoglalása. Betegek és módszerek: Retrospektív esetsorozatban vizsgáljuk a budapesti Uveitis Centrumban (a Semmelweis Egyetem Szemészeti Klinikájának Uveitis Ambulanciáján) 2018 és 2020 között adalimumabbal kezelt felnőtt, nem fertőzéses eredetű uveitises eseteinket. Eredmények: 13 beteget mutatunk be (8 nő, 5 férfi), átlagéletkor 45 (26–80) év. Az adalimumabot 12 beteg Humira, 1 beteg Amgevita készítmény formájában kapja. Az uveitis eredete 2 esetben ’birdshot’ chorioretinitis, 2 esetben Behçet-kór, 1 esetben sarcoidosis, 3 esetben retinalis vasculitis, 1 esetben Vogt–Koyanagi–Harada-betegség volt, és 4 esetben idiopathiás eredetűnek bizonyult. Az adalimumabkezelést 7 betegnél kellett elhagyni, elsősorban terápiás elégtelenség miatt, míg 6 betegnél jelenleg is eredményesen folyik a kezelés. Következtetés: Tapasztalataink alapján az adalimumab biztonságos, kevés mellékhatással bíró, hatékony kezelés számos uveitisformában önmagában adva vagy kis dózisú szteroiddal kiegészítve. Korábbi terápiákra (szteroid, immunszuppresszió) rezisztens esetekben is alkalmazható. A szemészetben a szisztémás biológiai terápia, az adalimumab bevezetése az uveitises betegek kezelésében a látóélesség megőrzése szempontjából sorsdöntő jelentőségű. Orv Hetil. 2021; 162(34): 1370–1375. Summary. Introduction: Adalimumab is a monoclonal antibody that inhibits TNFα and among other indications it can be a systemic treatment in the non-infectious intermediate, posterior and panuveitis. Objective: To summarize our experience in patients receiving adalimumab for adult non-infectious uveitis. Patients and methods: We investigate our adult cases of non-infectious uveitis treated with adalimumab between 2018 and 2020 in a retrospective case series at the Uveitis Center in Budapest (Semmelweis University, Department of Ophthalmology, Uveitis Department). Results: We present 13 patients (8 females, 5 males) with a mean age of 45 (26–80) years. Adalimumab is given to 12 patients as Humira and 1 patient as Amgevita. The etiology of uveitis was in 2 cases birdshot chorioretinitis, 2 Behçet’s disease, 1 sarcoidosis, 3 retinal vasculitis, 1 Vogt–Koyanagi–Harada disease, and 4 of idiopathic origin. Adalimumab treatment had to be discontinued in 7 cases, mainly due to therapeutic insufficiency, while in 6 cases we are still successfully treating patients. Conclusion: According to our experience, adalimumab is a safe and effective treatment, with minimal side effect in many forms of uveitis alone, or in combination with a low-dose steroid. It can also be used in cases where traditional immunosuppressive therapies are ineffective. In ophthalmology, systemic biologic therapy, availability of adalimumab in the treatment of uveitis is crucial for maintaining visual acuity at affected patients. Orv Hetil. 2021; 162(34): 1370–1375.

Long noncoding RNA intersectin 1-2 gradually declines during adalimumab treatment, and its reduction correlates with treatment efficacy in patients with ankylosing spondylitis

Previous studies show that long noncoding RNA intersectin 1-2 (lnc-ITSN1-2) promotes the inflammation process and serves as a potential biomarker in autoimmune diseases, except for ankylosing spondylitis (AS). Therefore, this study aimed to explore the correlation of baseline lnc-ITSN1-2 expression with disease risk and activity of AS, and to investigate its longitudinal change with treatment response to a tumour necrosis factor alpha (TNFα) inhibitor in patients with AS. In total, 63 patients with AS receiving 12-week adalimumab treatment were included and their baseline clinical features were collected. Lnc-ITSN1-2 expression in peripheral blood mononuclear cells (PBMC) of patients with AS was detected by reverse transcription quantitative polymerase chain reaction. Meanwhile, Assessment in Spondyloarthritis International Society (ASAS) 40 response was evaluated at week 2 (W2), W4, W8, and W12. According to the ASAS40 response status at W12, patients with AS were classified into responders and non-responders. PBMC lnc-ITSN1-2 expression was also determined in healthy controls (N = 60). Lnc-ITSN1-2 expression was elevated in patients with AS compared to controls (P < 0.001). Baseline lnc-ITSN1-2 expression was positively associated with C-reaction protein (CRP) (P = 0.021), interleukin (IL)-1β (P = 0.020), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score (P = 0.040), and Ankylosing Spondylitis Disease Activity score with C-reactive protein (ASDASCRP) (P = 0.045) in patients with AS. Furthermore, lnc-ITSN1-2 expression declined during the treatment with adalimumab (P < 0.001). Notably, this reduction was more obvious in responders than non-responders. In conclusion, declined lnc-ITSN1-2 expression during the TNFα inhibitor treatment correlates with good treatment efficacy in patients with AS, suggesting its clinical value for AS management.