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Abstract Number: 1789

Infections Observed in Rituximab Treated Patients with Refractory Systemic Lupus Erythematosus (SLE): Results from a National Multicentre Register

Eoghan M. McCarthy1,2, Emily Sutton3, David A. Isenberg4, Anisur Rahman4, Benjamin Rhodes5, Peter Hewins6, Neil J McHugh7, Ben Parker8, Bridget Griffiths9, Peter Lanyon10, Edward M. Vital11, Lee-Suan Teh12, Mohammed Akil13, Hazem Youssef14, David P. D'Cruz15, Munther Khamashta16, Nicola Erb17, David Jayne18, Christopher J. Edwards19, Athiveer Prabu20, Michael Batley21, Nagui Gendi22, Bhaskar Dasgupta23,24, Richard J. Stratton25, Chee-Seng Yee26, Asad Zoma27, Caroline Gordon28, Antoni Chan29, Steven Young Min30, Shirish Dubey31, Jon King32, Denise De Lord33, Edmond O'Riordan34, Rachel Jeffery35, Waji Hassan36, Marian Regan37 and Ian N. Bruce38, 1NIHR Manchester Musculoskeletal Biomedical Research Unit, Central Manchester University Hospital NHS Foundation Trust, Manchester, United Kingdom, 2The University of Manchester, Centre for Musculoskeletal Research, Institute of Inflammation and Repair, Manchester Academic Health Science Centre, Mmanchester, United Kingdom, 3University of Manchester, Manchester Academic Health Science Centre, Arthritis Research UK Centre for Epidemiology, Manchester, United Kingdom, 4Centre for Rheumatology Research, University College London, London, England, 5Rheumatology, Queen Elizabeth Hospital, Birmingham, United Kingdom, 6Queen Elizabeth Hospital, Birmingham, United Kingdom, 7Rheumatology, Bath Institute of Rheumatic Diseases, Royal National Hospital for Rheumatic Diseases, Bath, United Kingdom, 8Stopford Building, Arthritis Research UK Centre for Epidemiology, Centre for Musculoskeletal Research, Institute of Inflammation and Repair, Manchester Academic Health Science Centre, The University of Manchester, Manchester, United Kingdom, 9Rheumatology, Freeman Hospital, Newcastle Upon Tyne, United Kingdom, 10Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom, 11Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, 12Department of Rheumatology, Royal Blackburn Hospital, Blackburn, United Kingdom, 13Sheffield Center Rheumatic Dis, Sheffield South Yorkshire, United Kingdom, 14Department of Rheumatology, NHS Grampian, Aberdeen, United Kingdom, 15Louise Coote Lupus Unit, Guy's and St Thomas' Hospital, London, United Kingdom, 16Louise Coote Lupus Unit, St Thomas' Hospital, London, United Kingdom, 17Department of Rheumatology, The Dudley Group NHS Foundation Trust, Dudley, United Kingdom, 18Medicine, Addenbrooke's Hospital, Cambridge, United Kingdom, 19University Hospital Southampton, Southampton, United Kingdom, 20Worcester Royal Hospital, Worcester, Worcester, United Kingdom, 21Rheumatology, Maidstone and Tunbridge Wells Hospital, Kent, United Kingdom, 22Rheumatology, Basildon & Thurroch University Hospitals NHS Trust, Basildon, Essex, United Kingdom, 23Southend University Hospital, Southend, United Kingdom, 24Rheumatology, Southend University Hospital, Essex, United Kingdom, 25Centre for Rheumatology and Connective Tissue Disease, University College London, London, United Kingdom, 26Department of Rheumatology, Doncaster and Bassetlaw Hospitals NHS Foundation Trust, Doncaster, United Kingdom, 27Rheumatology, Hairmyres Hospital, East Kilbride, United Kingdom, 28Rheumatology Research Group, School of Immunity and Infection, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom, 29Rheumatology, Royal Berkshire NHS Foundation Trust, Reading, United Kingdom, 30Rheumatology, Queen Alexandra Hospital, Portsmouth, United Kingdom, 31Rheumatology, University Hospitals Coventry and Warwickshire, Coventry, United Kingdom, 32Rheumatology, Derriford Hospital, Plymouth, United Kingdom, 33Rheumatology, Queen Elizabeth the Queen Mother Hospital, East Kent, United Kingdom, 34Renal Medicine, Salford Royal Foundation Trust, Manchester, United Kingdom, 35Rheumatology, Northampton General Hospital, Northampton, United Kingdom, 36Rheumatology, University Hospitals of Leicester, Leicester, United Kingdom, 37Rheumatology, Royal Derby Hospital, Derby, United Kingdom, 38Central Manchester University Hospital NHS Foundation Trust and Manchester Academic Health Science Centre, NIHR Manchester Musculoskeletal Biomedical Research Unit, Manchester, United Kingdom

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: infection and rituximab, SLE

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Session Information

Date: Monday, November 9, 2015

Session Title: Systemic Lupus Erythematosus - Clinical Aspects and Treatment Poster Session II

Session Type: ACR Poster Session B

Session Time: 9:00AM-11:00AM

Background/Purpose:

SLE is associated with a significantly increased risk of infection. Both disease activity and the medications required to control disease are contributory factors. Rituximab is used in the treatment of SLE patients refractory to standard immunosuppressive therapy. The objective of this analysis is to describe the frequency and pattern of infections associated with Rituximab use in this cohort of SLE patients.

Methods:

Patients with SLE (≥ 4 ACR 1997 criteria) on Rituximab enrolled in the BILAG-BR, a UK, multicentre, prospective study of safety and efficacy of biologics in SLE were analysed.  Infection related events were coded using Medra software. Serious infections (SI) were defined as any infection resulting in treatment with iv antibiotics, hospitalisation, disability or death. For the purposes of the study, infections occurring within 9 months of Rituximab were deemed to be therapy related.

Results:

In the period May 2010-March 2015, 208 Rituximab treated patients were followed for a median (IQR) of 1 (0.5-2) yrs. There were 204 infectious episodes observed in 77 (37%) patients, 173 (85%) of which occurred within the 9 month period of interest. 50 patients suffered multiple infections. There were 25 (14%) serious infections in 20 (10%) patients within the 9 month window. The overall and serious infection rates/100 patient years follow up were 57.9 and 8.3 respectively.

The frequency of all infections and SI’s are described in Table 1.The most frequent opportunistic infections reported were Candida (n=8 in 7 patients) and Herpes zoster (shingles) (n=6 in 6 patients).

The highest rate of infections occurred in the first 3 months following treatment with Rituximab: 102 (59%) which declined over time, with 57 (33%) infections occurring between 3 – 6 months and 14 (8%) between 6 – 9 months. A similar trend was noted for SI’s with 14 (56%) occurring within 3 months, 8 (32%) at 3-6 months and 3 (12%) at 6-9 months.  

There was a higher number and proportion of non-respiratory infections within the first 3 months post-rituximab (non-respiratory infections: < 3 months = 55/102 (54%) vs 3–9 months = 27/71 (38%), OR 1.9 (95% C.I. 1.03-3.5, p = 0.04). There were no significant differences in individual SI’s across the time points, although the proportion of non-respiratory SIs was also higher in the first 3 months post-rituximab  [8/14 (58%) vs 4/11 (36%)].

No infection related deaths were reported.

Conclusion:

An increased number of infections were observed in the first 3 months post-rituximab therapy with a higher proportion of these early infections being non-respiratory in nature. This could be explained by the period of maximum B cell depletion, the effect of concomitant glucocorticoids or the effect of disease activity before maximum efficacy of rituximab.  Physicians and patients should have increased vigilance for infection, particularly in the early months following rituximab therapy.

                                                 Table 1. Infection rates in Rituximab treated patients.

 

 

 

 

All infections (% all infections)

Serious Infections (% total SI)

Total

173

25

Respiratory

91 (53)

14 (52)

Urinary

30 (17)

  3   (11)

Opportunistic

15  (9)

1   (4)

Skin

10  (6)

0   (0)

GI

7 (4)

  4  (15)

Other

   20 (12)

 3 (19)


Disclosure: E. M. McCarthy, None; E. Sutton, None; D. A. Isenberg, Bristol-Myers Squibb, 2; A. Rahman, Bristol-Myers Squibb, 2; B. Rhodes, None; P. Hewins, None; N. J. McHugh, None; B. Parker, None; B. Griffiths, None; P. Lanyon, None; E. M. Vital, None; L. S. Teh, None; M. Akil, None; H. Youssef, None; D. P. D'Cruz, GlaxoSmithKline, 2,UCB, 8,Eli Lilly and Company, 5; M. Khamashta, Bristol-Myers Squibb, 2; N. Erb, None; D. Jayne, None; C. J. Edwards, Abbvie, Pfizer, Lilly, Celtrion, Mundipharma, Samsung, Anthera, UCB, Celgene, Roche, Bristol-Myers Squibb, Janssen, 8; A. Prabu, None; M. Batley, None; N. Gendi, None; B. Dasgupta, GSK, Servier,UCB, 5; R. J. Stratton, None; C. S. Yee, None; A. Zoma, Bristol-Myers Squibb, 2; C. Gordon, UCB, 2,UCB,, 5,Merck Pharmaceuticals, 5,Paraxel, 5,Eli Lilly and Company, 8; A. Chan, None; S. Young Min, None; S. Dubey, None; J. King, None; D. De Lord, None; E. O'Riordan, None; R. Jeffery, None; W. Hassan, None; M. Regan, Roche Pharmaceuticals, 8,Chugai, 8; I. N. Bruce, Bristol-Myers Squibb, 2,GSK, 8,Roche Pharmaceuticals, 5.

To cite this abstract in AMA style:

McCarthy EM, Sutton E, Isenberg DA, Rahman A, Rhodes B, Hewins P, McHugh NJ, Parker B, Griffiths B, Lanyon P, Vital EM, Teh LS, Akil M, Youssef H, D'Cruz DP, Khamashta M, Erb N, Jayne D, Edwards CJ, Prabu A, Batley M, Gendi N, Dasgupta B, Stratton RJ, Yee CS, Zoma A, Gordon C, Chan A, Young Min S, Dubey S, King J, De Lord D, O'Riordan E, Jeffery R, Hassan W, Regan M, Bruce IN. Infections Observed in Rituximab Treated Patients with Refractory Systemic Lupus Erythematosus (SLE): Results from a National Multicentre Register [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/infections-observed-in-rituximab-treated-patients-with-refractory-systemic-lupus-erythematosus-sle-results-from-a-national-multicentre-register/. Accessed February 28, 2021.
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