Patients receiving RTX should have serum immunoglobulins (especially IgG and IgM) checked prior to each cycle of RTX. There are limited data with regard to response to hepatitis B immunization in patients with rheumatic disease receiving biologic therapy. Close monitoring of serum amino-transaminases and HBV DNA load is recommended in patients with occult or overt HBV infection treated with biologic therapy (grade 1C SOA 99%). Of the 82 patients with overt HBV treated with an anti-TNF, five had acute liver failure, one required a liver transplant and four died. The half-lives of biologic therapies are shown in Table 7. A study of 81 immunosuppressed children who received VZIG following household exposure to varicella, found a moderate response to VZIG, although 49 children still developed varicella infection, including some who had serological evidence of past exposure . The association between anti-TNF treatment and various disorders of peripheral nerves such as Guillain–Barré syndrome, chronic inflammatory demyelinating polyneuropathy and mononeuropathy multiplex has been highlighted in various case series and case reports . Treatment should be stopped if PML develops. While most safety evidence, especially long-term observational data, exists for the first generation anti-TNF agents in RA, since the last guideline there has been significant new information from clinical studies regarding the safety of both anti-TNF agents and the newer non-TNF biologic DMARDs, both in RA and in other licensed IA indications. Clinical Excellence Awards: apply for BSR support We'll consider applications for bronze, silver, gold and platinum awards, as well as applications for renewals Find out more. All patients should be reviewed for drug safety in a specialist department at least every 6 months. Although there is no evidence to suggest an absolute total Ig, IgM or IgG threshold where RTX should not be given, clinicians and patients should be aware that the risk of serious infection increases as serum IgG level falls. To date, no studies have examined the risk in other pre-malignant conditions such as Barrett’s oesophagus or colonic polyps. Recommendations based on systematically reviewed evidence are given below. All other authors have declared no conflicts of interest.  has shown that some response occurs, but it is attenuated if the patient is on the drug. The reference lists of retrieved articles were manually searched for additional papers and these were included if appropriate. Higher rates of MM were also observed in the TNF group compared with those receiving csDMARD; however, again statistical significance was not achieved (IRR = 1.14, 95% CI: 0.8, 1.6). Comorbidities such as chronic obstructive pulmonary disease (COPD) [24, 38], interstitial lung disease (ILD)  and renal failure  have been associated with higher rates of serious infection in RA patients receiving anti-TNF agents. Refer to the earlier section on diverticular disease. The requirement for brand name prescribing and entry of patients into registries is essential to ensure ongoing pharmacovigilance including the collection of long-term observational safety data in this area. If clinically indicated, UST may be used in patients with hepatitis B following prophylactic anti-viral treatment. There is no evidence to suggest that RTX, ABA or UST increases the risk of demyelinating diseases. Therefore, though it is safe to give hepatitis B vaccine to a patient on anti-TNF treatment, if possible, the first hepatitis B vaccine should be given prior to commencing anti-TNF therapy. However, the WHO recommends using either test and the European Centre for Disease prevention and control recommends using both [78, 79]. A retrospective cohort study of 420 women with RA, Momohara et al. Any patient who develops symptoms consistent with TB, even if their pre-biologic TB screening was negative, should be investigated for active TB, initially with a chest X-ray and sputum examination. This should be administered preferably >14 days before starting biologic therapy (grade 2C, SOA 97%). Haematological abnormalities have been reported in patients treated with anti-TNF agents but in many cases there have been other co-prescribed medications that may have been responsible for these changes. However, in this study, among 633 patients with recent or current exposure to biologics at the time of vaccination, no case of HZ or varicella occurred. There are no data available regarding UST in this context. Baseline assessment for all should include (grade 1C SOA 98%): laboratory evaluation of full blood count (FBC), creatinine/calculated glomerular filtration rate (GFR), alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST), albumin, tuberculin skin test (TST) or interferon-gamma release assay (IGRA) or both as appropriate, hepatitis B and C serology, and a chest radiograph. There is circumstantial evidence indicating that TNF blockade may directly modulate humoral responses , with one study suggesting that TNF blockade with ETN decreases responses to the hepatitis B vaccine; patients with RA who were treated with MTX had very good response rates, whereas those treated with an MTX–ETN combination or ETN alone had poor response rates . In a retrospective analysis of 3117 patients who received UST for up to 5 years, the rate of malignancy (other than non-melanoma skin cancers) was found to be 0.59/100 patients-years (UST 45 mg) and 0.61/100 patient-years (UST 90 mg) . Although the results from studies appear reassuring for this group of drugs with regards to TB reactivation, until more data are available, the advice given for anti-TNF therapy should be considered. Clinicians should be vigilant for progressive multifocal leukoencephalopathy (PML), which has been primarily associated with RTX but has also been reported with anti-TNF therapy. Data are lacking on the risk of TCZ and UST and HZ. A 2009 meta-analysis suggested that the risk of serious infections during ABA treatment [odds ratio (OR) = 1.35, 95% CI: 0.78, 2.32 vs placebo) is not significantly increased . The study found an association between baseline total cholesterol: HDL-cholesterol ratio and MACE, with poor RA disease control associated with a higher risk of future MACE. Saad AA, Symmons DP, Noyce PR, Ashcroft DM. Patients should be monitored every 3 months with close involvement with a TB specialist throughout. Cobo-Ibanez T, Descalzo MA, Loza-Santamaria E, Carmona L, Munoz-Fernandez S. Michaud TL, Rho YH, Shamliyan T, Kuntz KM, Choi HK. Patients receiving immunosuppressive therapy are advised to have both influenza and pneumococcal immunization. The BSRBR-RA compared 190 RA patients with a past history of CIS of the cervix who were receiving anti-TNF therapy (73% of whom started anti-TNF therapy within 10 years of CIS) against csDMARD controls . High risk patients (e.g. Evidence-based information on DMARD pregnancy from hundreds of trustworthy sources for health and social care. Although some studies have identified older age as an independent risk factor for serious infection with anti-TNF drugs, two recent studies have been reassuring. A model audit tool template is available for biologic therapy imitation and monitoring.  monitored Ig levels every 8–16 weeks in patients with RA receiving RTX and found that following RTX therapy ⩽3.9% had low IgA or total Ig levels at any time, while 14.8 and 37.9% had below normal IgG and IgM levels, respectively, any time. A pooled case analysis of 1246 patients receiving RTX for >5 years found no difference in cardiac events compared with the general RA population . Perez-Alvarez et al. It should be noted that the observational nature of the BSRBR-RA predisposes to channelling bias (patients with more severe disease are more likely to be enrolled into the anti-TNF cohort).  monitored the FBC of 106 patients with AS over a 6-month period and found Hb, MCV, iron, ferritin, CRP and ESR improved, reaching statistical significance. An almost identical risk was observed in the Swedish ARTIS registry . Matulis G, Juni P, Villiger PM, Gadola SD. Given the theoretical risks, the advice substantiated by evidence for RA should be applied to patients with other IA problems. Limitations of this study included its relatively short follow-up period of mean 3.5 years for the anti-TNF patients, and the fact that the mean interval between CIS or cervical dysplasia diagnosis and commencement of anti-TNF therapy was 17.7 years. BSRBR-RA included data from 11 798 RA patients receiving ADA, ETN or INF, and 3598 csDMARD controls. Similarly, there appears to be a potential beneficial effect of anti-TNF therapy on CV events but further data are required before firm conclusions can be drawn. BSR has published guidelines stressing the importance of monitoring for early detection of toxicity. Risk would also be increased if active disease caused immobility.  found that the IgG response to vaccination was restored in patients who had received RTX 6–10 months prior to vaccination. Baseline assessment should include height, weight, blood pressure and laboratory evaluation [full blood count (FBC), calculated glomerular filtration rate (GFR), alanine aminotransferase (ALT) and/or asparate aminotransferase (AST), albumin; GRADE 1C, 97%]. Correspondence to: Christopher Holroyd, Rheumatology Department, University Hospital Southampton, Southampton, SO16 6YD, UK. Pre-existing ILD is not a specific contraindication to biologic therapy; however, caution is advised in patients with poor respiratory reserve (in whom a significant drop in lung function would be potentially life threatening); in this situation it is advised to work closely with a respiratory physician with a specialist interest in ILD (grade 2C, SOA 99%). Patients having i.v. Concomitant steroid use has also been repeatedly associated with higher infection risk [24, 38]; however, in many patients the introduction of biologic therapies will enable reduction or cessation of steroid exposure. Rises in transaminases (ALT and AST) have been found with TCZ in a number of studies. A US database study of 11 219 RA patients  found the lowest IR of ILD occurrence was with ABA (IR = 4.0/1000 person-years, 95% CI: 1.6, 8.2/1000 person-years); the highest being with INF (IR = 12.2/1000 person-years, 95% CI: 5.6, 23.2/1000 person-years); however, no significant differences in the incidence of ILD was found between the different biologic classes. This is thought to be due to peripheral margination of neutrophils, but is not associated with an increased frequency of infection. We would therefore recommend that the same precautions outlined for anti-TNF agents be taken for UST. Most patients receiving concomitant HAART had good clinical outcomes [104–106]; the sole exception is a case report of an HIV patient with PsA in whom ETN had to be stopped due to recurrent infections .  in a pooled meta-analysis of five RCTs and two long-term extension studies, compared with 2.0/1000 person-years reported in the control group. The hallmark feature of this condition is persistent symmetric polyarthritis (synovitis) that affects the hands and feet, though any joint lined by a synovial membrane may be involved. Mariette et al. In addition, there were a very small number of articles identified through the search strategy that we were unable to obtain through university library channels. However, two out of seven patients (29%) who did not receive prophylactic anti-viral therapy were noted to have an increase in viral load. There is no convincing data to suggest an association between any of the non-anti-TNF biologics and the development of psoriasis. kinase inhibitors). Patients receiving csDMARD may require more regular laboratory monitoring (as per BSR/BHPR non-biologic DMARD guidelines, 2017) (grade 2B, SOA 96%). Rheumatoid arthritis (RA). This is supported by evidence from several smaller studies [283, 284]. This current guideline supersedes the previous 2008 BSR/BHPR guideline . A 2014 review  found no cases of active TB recorded in patients with RA and other rheumatic conditions treated with RTX and ABA, and in fact, argued against pre-screening for TB in patients receiving these two biologics. Fifty-three new malignancies were identified in this cohort, with no significant difference in the rate of new malignancies between groups. A higher incidence of psoriasis has also been found in the BIOBADASER cohort . It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide, This PDF is available to Subscribers Only. The potential benefit of preventing post-operative infections by stopping biologics (different surgical procedures pose different risks of infection and wound healing) should be balanced against the risk of a peri-operative flare in disease activity (grade 2B, SOA 97%). Askling J, Klareskog L, Blomqvist P, Fored M, Feltelius N. Wong AK, Kerkoutian S, Said J, Rashidi H, Pullarkat ST. Baecklund E, Hellgren K, Sundstrom C, Askling J; Rubbert-Roth A, Sebba A, Brockwell L et al. (Also refer to vaccination recommendations while on biologic therapy). Although recent data are reassuring, biologics should be used with caution in patients with class III or IV cardiac failure, working closely with a cardiologist (grade 2C, SOA 96%). Comfortable at rest. 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