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Objectives Real-world secukinumab gastrointestinal related adverse events (GIRAE) data as treatment for ankylosing spondylitis (AS) and psoriatic arthritis (PsA) are lacking. We aimed to achieve this through baseline evaluation of pre-existing inflammatory bowel disease (IBD), rates and predictors of GIRAE. Methods Patient electronic and paper records commencing secukinumab from ten UK hospitals between 2016–2019 were reviewed. GIRAE after initiation were defined as: definite (objective evidence of IBD (biopsy proven), clear temporal association, resolution of symptoms on drug withdrawal, no alternative explanation felt more likely), probable (as per definite, but without biopsy confirmation) or possible (gastrointestinal symptoms not fulfilling definite or probable criteria). Results Data for all 306 patients started on secukinumab were analysed: 124 (40.5%) AS and 182 (59.5%) PsA. 24/306 (7.8%) experienced GIRAE after starting secukinumab. Amongst patients who developed GIRAE, 4 (1.3%) had definite, 7 (2.3%) probable and 13 (4.2%) possible IBD. All definite cases were patients with AS and stopped secukinumab; two had pre-existing IBD and two (0.7%) were de-novo cases of which one required surgical intervention. Seven patients (2.3%) had pre-existing diagnoses of IBD prior to initiation of which 5 patients experienced GIRAE. Conclusion Absolute rates of new IBD in patients starting secukinumab are low. The majority of patients developing new GIRAE did not develop objective evidence of IBD or stop therapy. For patients with pre-existing IBD and AS the risk of GIRAE is much higher, and prescribing alternatives should be considered.

Numerous post-Streptococcal syndromes (PSS) have been described in the literature. The role of antibiotic therapy in the management of PSS is best established with acute rheumatic fever. We present a patient with streptococcus-associated medium vessel vasculitis with multiple flares despite immunosuppressive therapy that achieved a sustained remission with long term oral penicillin V 250 mg twice daily.

Background Secukinumab is a selective interleukin-17a inhibitor (anti-IL17) and an effective treatment option for psoriatic arthritis (PsA) and ankylosing spondylitis (AS). Phase III study safety data indicate a possible risk of inflammatory bowel disease (IBD), a link which is biologically plausible as IL-17 is known to influence intestinal immunopathology. Real world data for secukinumab gastrointestinal safety are limited. We set out to describe the post-licensing experience of secukinumab in routine care, evaluating both baseline evaluation of pre-existing IBD as well as incident gastrointestinal adverse effects. Methods We undertook a retrospective cohort study. Ten centres from the South East of England participated. All records for patients commencing secukinumab at each centre between 2016-2019 were reviewed. A fully anonymised data collection form was used to collate patient information. Questions sought to answer whether IBD screening had occurred prior to secukinumab initiation. All gastrointestinal adverse events were reviewed. IBD-related adverse events after initiation were defined as: definite (biopsy confirmed, objective inflammation from biomarkers, clear temporal association, improvement on drug withdrawal), probable (as per definite, but without biopsy confirmation) or possible (gastrointestinal symptoms not fulfilling definite or probable criteria). Results Data for 306 patients were available: 124 (40.5%) with AS and 182 (59.5%) with PsA. 106 (34.6%) of patients had documented assessment for IBD prior to initiation; 7 of which already had pre-existing diagnoses of IBD. 24 (7.8%) patients experienced gastrointestinal related adverse events after starting secukinumab; 18 of which were formally investigated for bowel disease due to symptoms. Amongst patients who developed gastrointestinal symptoms, 4 (1.3%) had definite, 7 (2.3%) probable and 13 (4.2%) possible IBD. Out of the 4 with definite IBD; all were AS patients, all stopped secukinumab, three had pre-existing IBD and one (0.3%) case of de-novo IBD required surgical management for an inflammatory perianal abscess. All 7 patients with probable IBD had symptom resolution on withdrawal of secukinumab. Of these, 4/7 were PsA and 3/7 were AS. For the 13 patients that fulfilled possible IBD criteria, symptoms resolved without intervention and continued secukinumab treatment. Conclusion Absolute rates of new IBD in patients starting secukinumab are low. In addition, a majority of patients developing new gastrointestinal symptoms did not develop objective evidence of IBD or stop therapy. However, our experience suggests that in people with pre-existing IBD the risk is much higher. Only one-third of patients had documented evidence of screening for IBD at baseline. Given that only one patient developed de-novo IBD in the cohort, our experience would not support the practice of pre-screening for IBD prior to starting anti-IL17 therapy. Further research to evaluate this would be wise to focus specifically on the characteristics of AS patients, stratifying IBD risk prior to anti-IL17 initiation. Disclosures I.A. Onac: Other; Education support to attend conference from Abbvie. C. Tacu: Honoraria; Novartis Pharmaceutical UK - Speaker Fee. Other; education support- course - Novartis. B.D. Clarke: None. M. Lloyd: Other; departmental support from Novartis. V. Hajela: None. T. Batty: None. J. Thoroughgood: None. S. Smith: None. H. Irvine: None. D. Hill: None. G. Baxter: None. N. Horwood: Other; attend conferences from Lilly and Abbvie. S. Mahendrakar: Other; Education support to attend conferences from Lilly. R. Rajak: Honoraria; Honoraria for speaker: Eli Lilly, Amgen, Internis, Roche, UCB, Abbvie. Honoraria for chairing: Roche, Novartis, Eli Lilly, UCB. S. Griffith: Other; None declared. P. Kiely: Honoraria; Abbvie, BMS, Gilead, Lilly, Novartis, Sanofi. Member of speakers’ bureau; Abbvie, BMS, Lilly, Novartis, Sanofi. J.B. Galloway: Honoraria; Speaker fees, travel support and grants from Lilly, Abbvie, BMS, Celgene, Janssen, Pfizer, UCB, Sanofi.

Aim. To achieve extensive information (regional) in relation with the tuberculosis identified in current clinical practice in patients with inflammatory rheumatic diseases treated with biological agents. Patients and methods. Twenty seven rheumatologists from 11 Romanian medicale center agreed to participate voluntarily and provide required data on tuberculosis (TB) occurring between January 1999 and June 2011 in their patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthropathy (PsA) in relation with anti-TNFα agent. This observational research included 693 patients (RA n=492, SA n=137, AP n= 64). All patients were screen for latent Mycobacterium tuberculosis infection (LTBI) before they start anti-TNFα treatment. Chemoprophylaxis with isoniazid before anti-TNFα therapy is recommended if the diameter of tuberculin skin test reaction is more than 5 mm (before 2005 only if indurations was more than 10 mm). We recorded the demographic characteristics, and complex information about disease, treatment, tuberculosis diagnosis and the comorbidities. Incidence rate of TB are presented as events/1,000 person-years with associated 95% confidence interval [95%CI]. Results. Fifteen patients were diagnosed with TB, most (60%) were born in rural areas and 40% in areas with higher incidence (≥ 80%ooo) of TB. The incidence of TB was 1.65‰ (IC95% [11.54-34.63]). The extra pulmonary sites were present in 53.3% of the cases. Cultures were positive for Mycobacterium tuberculosis in 11 cases (73.3%). Suspicion of TB was confirmed histological in 6 cases (40%). The average duration of developing TB after initiation of TNF inhibitor was 23.26 months (range one month to 120 months). In 7/12 TB cases treated with IFX the incidence appeared in the first year of treatment. Any of known risk factors don’t have a significant influence in our cohort. Conclusions. The risk of reactivation of a latent TB during biologic therapy is greater in patients with rheumatic inflammatory diseases living in geographical areas with high endemicity of TB infection. Reduced compliance to chemoprophylaxis may be responsible for the occurrence of these cases.