Drug Adherence and Persistence of Patients with Moderate to Severe Psoriasis Treated with Biologic Medications in a US Commercially Insured Population

<b><i>Background:</i></b> Adalimumab (ADA), certolizumab pegol (CER), etanercept (ETA), guselkumab (GUS), ixekizumab (IXE), secukinumab (SEC), and ustekinumab (UST) are biologic medications approved in the USA for the treatment of moderate to severe psoriasis. We examined drug adherence and persistence of patients with moderate to severe psoriasis who initiated these seven biologic medications. <b><i>Methods:</i></b> Adult patients with ≥1 pharmacy/medical claim for any of the seven psoriasis medications and ≥1 diagnosis of psoriasis in the previous 6 months between July 1, 2014 and June 30, 2019 were selected from the IBM MarketScan® Commercial Claims and Encounters Database. The index date was defined as the date of the first prescription fill. Patients were required to have continuous health plan enrollment during the 6 months prior to their index date and ≥9 months after. Patients were grouped into seven study cohorts based upon their index biologic medication. Adherence was measured using the proportion of days covered (PDC) and defined by a PDC ≥80%. Adherence and persistence with index biologic medications were examined during fixed follow-up periods of 3, 6, and 9 months, with a subpopulation analysis carried out among patients with 12 months of follow-up. <b><i>Results:</i></b> Among psoriasis patients with ≥9 months of continuous enrollment included in the study population, the number of those who initiated each biologic medication was 10,324 for ADA, 431 for CER, 3,092 for ETA, 821 for GUS, 1,766 for IXE, 4,132 for SEC, and 5,441 for UST. The mean age at the time of initiating biologic treatment was 46.9 years. During the 9-month follow-up period, the proportions of adherent patients (i.e., PDC ≥80%) were numerically higher among those treated with UST (59.9%) and GUS (56.9%), followed by those treated with SEC (46.1%), IXE (45.5%), ADA (44.7%), ETA (33.9%), and CER (22.0%). The proportions of patients who were persistent with their index biologic medication during the 9-month follow-up period were numerically higher among those treated with UST (70.1%) and GUS (67.8%), followed by those treated with IXE (47.3%), SEC (46.9%), ADA (28.7%), CER (14.8%), and ETA (10.7%). <b><i>Conclusions:</i></b> In this large healthcare claims database analysis of psoriasis patients treated with seven different biologic medications, adherence was numerically higher among those treated with UST or GUS. UST and GUS were also associated with numerically greater persistence.

The Importance of Monitoring the Postpartum Period in Moderate to Severe Crohn’s Disease

Background Prior research demonstrates Crohn’s disease patients often do well in pregnancy; however, less is known about the risk of flare in the postpartum period. Methods A retrospective chart review was conducted at a tertiary care inflammatory bowel disease center. All pregnant women with Crohn’s disease who were followed in the postpartum period, defined as 6 months after delivery, were included. Statistical analysis included χ 2 analysis, Wilcoxon rank sum test, and logistic regression analysis. The primary outcome of interest was rate of flare in the postpartum period. Results There were 105 patients included in the study, with a majority (68%) on biologic medication during pregnancy. Thirty-one patients (30%) had a postpartum flare at a median of 9 weeks (range 2–24 weeks). Twenty-five patients (81%) had their postpartum flare managed in the outpatient setting with medications (only 4 of these patients required prednisone). 6 of 31 patients (19%) were hospitalized at a median of 4 weeks (range 2–26 weeks) after delivery, requiring intravenous corticosteroids or surgery. In multivariable regression, there was no significant increase in risk of postpartum flare with increasing maternal age, flare during pregnancy, or steroid or biologic use during pregnancy. Smoking during pregnancy increased risk of postpartum flare (odds ratio, 16.2 [1.72–152.94], P &lt; 0.05). Conclusion In a cohort of Crohn’s disease patients, 30% experienced a postpartum flare despite being on medical therapy, but most were able to be managed in the outpatient setting.

Patient perspectives on the British Columbia Biosimilars Initiative: a qualitative descriptive study

In May 2019, the Government of British Columbia (BC) announced the implementation of the Biosimilars Initiative, mandating the switch of biologic (originator) drugs to biosimilars for certain patient populations in the hopes of optimizing public resources. Through this qualitative study, we aimed to identify patients’ perspectives as they undergo this change. From October 2019 to July 2020, we conducted nine pre- and six post-switch to biosimilar interviews with BC, English speaking participants, who were 18 years or older, and were currently taking a biologic medication. Participants were interviewed pre- and post-switch to a biosimilar medication and interviews were audio-recorded and transcribed verbatim for qualitative analysis. Interviews were thematically analysed and major themes and sub-categories were elucidated. The themes derived from pre and post-switch interviews captured participants’ anticipated or experienced barriers and enablers to the policy change. In general, the fears and apprehension of participants approaching the switch, including concerns surrounding the efficacy and safety of biosimilars, were addressed by their rheumatologist and social support circles. For the most part, participants were able to successfully manage their disease regardless of their baseline concerns about efficacy and safety. Experiences of changes in health delivery models were also observed secondary to the impact of the COVID-19 pandemic amongst participants. This study is the first of its kind to characterize the patient perspective regarding the BC Biosimilars Initiative. The incorporation of the patient perspective, including adequate provider-patient communication and shared decision-making can help to inform future non-medical switching policy changes.

A Retrospective Analysis of Characteristic Features of Responders and Impaired Patients to a Single Injection of Pure Platelet-Rich Plasma in Knee Osteoarthritis

(1) Background: The emergence of injectable “biologic” medication creates a new approach to treat osteoarthritis (OA). Among them, the use of intra-articular injection of PRP became widespread despite the absence of consensus regarding its optimal composition. The aim of this study was to retrospectively correlate an extensive biological characterization of injected PRP to the clinical responses of patients presenting knee OA. (2) Methods: This retrospective study included 75 patients with knee OA. Cartilage lesions were assessed using magnetic resonance imaging and the International Cartilage Regeneration Society (ICRS) classification. PRP extensive biological characterization was performed and patients’ subjective symptoms were recorded before injection and 3 and 6 months after injection using the Knee injury and Osteoarthritis Outcome Score (KOOS). Responders were defined by an improvement of 10 points on KOOS. (3) Results: At 6 months, 63.0% of the patients were responders. Impairment was characterized by a significantly higher proportion of patients with three compartments altered at baseline MRI and receiving a significantly higher dose of platelets compared to responders. (4) Conclusions: Single injection of pure PRP resulted in significant clinical improvement in the management of knee OA. Both baseline MRI and PRP biological features may be predictive factors of the clinical response, highlighting that a better understanding of action mechanism of PRP is still required.

1074. Understanding Screening Practices for Hepatitis B Prior to Starting Biologics at an Academic Medical Center

Background It is estimated that 0.3% of the US population has chronic hepatitis B (HBV) infection, most of whom are asymptomatic. When a patient receives a biologic medication, chronic HBV can reactivate with mortality rates as high as 40%. We aim to understand HBV screening practices prior to starting biologics at a single tertiary academic medical center. Methods We retrospectively reviewed over 500 patient charts. These patients aged ≥ 18 years were prescribed a biologic medication at one of the three clinics (Dermatology, Rheumatology, or Gastroenterology) at Tufts Medical Center from January 2016 to April 2019. To determine the rate of HBV screening compliance, we reported the proportion of patients who had appropriate HBV serologies (HBV surface antigen and HBV core antibody) drawn prior to initiation of the biologic therapy. A survey was sent to providers from these departments to understand their current practices of HBV screening. Results 133 of 541 patients (25%) had been appropriately screened for HBV within six months prior to starting biologic therapy. 207 of 541 (38%) had been screened with appropriate serologies within ten years prior to starting a biologic. 23 providers participated in the survey, 7 each from the department of Rheumatology and Gastroenterology, and 9 from Dermatology. One-third of the providers were currently in training, another third were practicing for &lt; 5 years, and the remainder had &gt; 5 years of experience. 57% of the providers said they would screen everyone for HBV before starting a biologic. 78% of them chose the appropriate serologies. The time interval for rescreening was evenly spread amongst different providers, ranging from 3 months to 5 years. If a patient was switched to a new biologic, 48% of physicians would repeat screening only if the patient was determined to be at risk of reactivation or new acquisition of HBV. The major barrier to screening was uncertainty regarding who to screen and which tests to order. Conclusion This data reveals that there is inadequate screening for HBV prior to biologic therapy. The survey highlighted areas for quality improvement, including the need for wider dissemination of screening guidelines and development of a protocolized approach to ordering the correct tests. Disclosures All Authors: No reported disclosures

Corneal Neurotization and Novel Medical Therapies for Neurotrophic Keratopathy

Purpose of Review Neurotrophic keratopathy (NK) is a degenerative corneal disease characterized by decreased corneal sensibility and impaired corneal healing. In this article, we review surgical techniques for corneal neurotization (CN) and novel medical therapies for the treatment of NK. Recent Findings In recent decades, there has been a paradigm shift in the treatment strategies for NK. New minimally invasive direct and indirect CN approaches have demonstrated efficacy at improving best-corrected visual acuity and central corneal sensation while decreasing surgical morbidity. In addition, several targeted medical therapies, such as recombinant human nerve growth factor (rhNGF), regenerating agents (RGTA), and nicergoline, have shown promise in improving corneal epithelial healing. Of these options, cenegermin (Oxervate®, Dompé), a topical biologic medication, has emerged as an approved medical treatment for moderate to severe NK. Summary NK is a challenging condition caused by alterations in corneal nerves, leading to impairment in sensory and trophic function with subsequent breakdown of the cornea. Conventional therapy for NK depends on the severity of disease and focuses primarily on protecting the ocular surface. In recent years, numerous CN techniques and novel medical treatments have been developed that aim to restore proper corneal innervation and promote ocular surface healing. Further studies are needed to better understand the long-term efficacy of these treatment options, their target populations, and the potential synergistic efficacy of combined medical and surgical treatments.

P137 Growing up on biologics: a case report of development of NMDAr encephalitis in a young person with JIA on abatacept

Background A 12-year-old female with JIA on biologic medication (IV abatacept every three weeks) presented with a first generalised tonic-clonic seizure on background of preceding headache and fatigue. The seizure self-terminated but disorientation and encephalopathy ensued. MRI brain demonstrated lesions with high signal intensity in the left periventricular and right occipital regions. The clinical picture and radiological imaging suggested a broad differential diagnosis including CNS infection, JC virus associated progressive multifocal leucoencephalomalacia (PML), acute disseminated encephalomyelitis (ADEM) and Anti-N-methyl-d-aspartate receptor (NMDAr) encephalitis. She was commenced on IV ceftriaxone, acyclovir and clarithromycin. All bloods including inflammatory markers and infection serology were unremarkable. CSF was acellular and JC virus PCR negative. NMDAr encephalitis was initially considered unlikely (pre-existing immunosuppression, abnormal MRI brain and no evidence of ovarian teratoma on abdominal MRI pelvis). However more classical clinical features developed including further seizures, significant movement disorder, cognitive dysfunction, sleep and speech dysfunction. Anti-NMDAr antibodies in both serum and CSF were positive. She made a good recovery following IV steroids, plasmapheresis and rituximab and was discharged home after a 10-week admission. NMDAr encephalitis developed three years after commencing abatacept treatment. Previous immune modulating treatment included methotrexate (since age 2 years), Etanercept (age 5-8 years) and Tocilizumab (aged 8-10 years). Flares of disease following a period of control necessitated the changes in therapy. Methods A literature review was conducted to explore the relationship between NMDAr encephalitis and biologic medication. A yellow card report and information request to abatacept manufacturer were also submitted. Results No previous cases of NMDAr encephalitis in patients on abatacept or paediatric cases related to biologic therapy are described. There are reports of adults developing NMDAr encephalitis on Adalumimab for Crohn’s disease and etanercept for rheumatoid arthritis. NMDAr encephalitis has also been described in patients on immune checkpoint inhibitors for malignant melanoma (nivolumab and ipilimumab). Known triggers of production of anti-NMDA receptor antibodies include tumours (ovarian teratoma; rarely associated in patients under 12 years) and viral infections. Developing autoimmune disorders on biologic medication is well reported, most notably psoriasis and inflammatory bowel disease. In relation to abatacept specifically, the development of anti-nuclear antibodies (ANA) and psoriasis have been described. However, patients with autoimmune disorders are known to be of increased risk for additional immune disease. A new cohort of patients are emerging who have received multiple biologic medications and the development of autoimmune conditions despite immunosuppression needs to be considered. Conclusion We describe the first case of NMDAr encephalitis occurring in a child on abatacept therapy, and the first case in JIA. We are unable to determine what contribution a history of autoimmune disease or immunomodulating therapy has made on its development in this case. Disclosures R. Close: None. P. Bale: None. K. Gallagher: None. G. Ambegaonkar: None. T. Rossor: None. N. Abbassi: None. K. Armon: None.