Rigerimod plus Standard of Care for Systemic Lupus Erythematosus

Systemic lupus erythematosus (SLE) is a long-term condition causing inflammation to the joints, skin and other organs. Symptoms presented are usually very general, including fever, joint pain and skin rash but can progress to the most severe, e.g. kidney failure. SLE typically has patterns of flare-ups where the condition gets worse for a period of time. The disease is likely to be caused by a combination of genetic and lifestyle factors and most commonly affects middle-aged women and those of African-Caribbean ethnicity.


http://www.io.nihr.ac.uk/report/rigerimod-plus-standard-of-care-for-systemic-lupus-erythematosus/




From the NIHR Innovation Centre

Lesinurad for treating chronic hyperuricaemia in people with gout [TA506]

New: Technology appraisal guidance


Lesinurad is not recommended within its marketing authorisation, that is, with a xanthine oxidase inhibitor for treating hyperuricaemia in adults with gout whose serum uric acid is above the target level despite an adequate dose of a xanthine oxidase inhibitor alone.


This recommendation is not intended to affect treatment with lesinurad that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

NIHR Signal Stopping biological drugs for rheumatoid arthritis can lead to twice the relapse rate

It seems safer to reduce the dose of biological drugs, rather than to stop them if people with rheumatoid arthritis and their doctors want to avoid relapse. Stopping these powerful drugs caused the disease to recur in 58% of people compared with 29% who continued them. Reducing the dose also led to more relapses for people in remission, but did not cause those with low-grade disease activity to worsen.




Rheumatoid arthritis is a chronic disease which causes pain, swelling and stiffness in the small joints of the hands and feet. It can cause more widespread inflammation. The disease has episodes of improvement and deterioration so judging the effects of treatment can be difficult. Drug treatments suppress the immune system, putting people at higher risk of infection.




From the NIHR Dissemination Centre

NICE draft guideline on rheumatoid arthritis - consultation open

NICE draft guidelines on rheumatoid arthritis in adults are open for consultation until 1st March 2018.


The proposals include giving adults with rheumatoid arthritis access to specialist physiotherapy to help manage their condition and improve their fitness, flexibility and strength.


See the draft guidelines and register to contribute to the consultation process at https://www.nice.org.uk/guidance/indevelopment/gid-ng10014/consultation/html-content-2

Upadacitinib for Adults with Moderate to Severe Active Rheumatoid Arthritis After Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (DMARDs) or Biologic DMARDs Failure

There is currently no cure for rheumatoid arthritis and treatment aims to improve quality of life and to prevent or reduce joint damage. The most common treatment options are steroids to reduce inflammation, medications to reduce pain and swelling, and medications that slow the progression of joint damage from RA. Upadacitinib is currently being developed to be taken orally as a treatment option for those who have active moderate to severe RA who do not respond to certain treatment options. This drug works by stopping the inflammation caused by a specific type of protein and if licensed, it may be an option that can be used earlier in the treatment pathway.

From NIHR Innovation Observatory

New Getting It Right First Time leads announced

Clinical leads for three areas of the Getting It Right First Time programme have been announced.

The £60m clinical efficiency and safety programme is run by NHS Improvement and sees clinician led teams look at service lines in every trust in England to determine whether they are operating at sufficient scale, among other factors.

Some trusts change their practices or stop providing some services as a result of the subject area GIRFT reports published so far on orthopaedics and general surgery.

The programme announced clinical leads for endocrinology, rheumatology and stroke medicine last week.

To obtain this article copy and past it into an email and send to: librasryw@uhcw.nhs.uk

Tocilizumab (RoACTEMRA) [subcutaneous injection with an auto injector device] for adult patients with moderate to severe active rheumatoid arthritis - after DMARD failure

There is currently no cure for rheumatoid arthritis. The most common treatment options are steroids to reduce inflammation, medications to reduce pain and inflammation and medications that slow the progression of joint damage from RA. Tocilizumab is already licensed for the treatment of RA as both intravenous and subcutaneous (pre-filled syringe) formulations, however its use, via an auto-injector device is being developed. This is expected to improve the ease of patients treating themselves, in those who have active moderate to severe RA who do not respond to some conventional treatments

From the NIHR Innovation Observatory

Sarilumab for moderate to severe rheumatoid arthritis [TA485]

New Technology appraisal guidance from NICE:

Evidence-based recommendations on sarilumab (Kevzara) for treating moderate to severe rheumatoid arthritis in adults.

Sarilumab, with methotrexate, is recommended as an option for treating active rheumatoid arthritis in adults whose disease has responded inadequately to intensive therapy with a combination of conventional disease-modifying antirheumatic drugs (DMARDs), only if:

• disease is severe (a disease activity score [DAS28] of more than 5.1) and
• the company provides sarilumab with the discount agreed in the patient access scheme.

Promonitor for monitoring response to biologics in rheumatoid arthritis [MB126]

New Medtech innovation Briefing from NICE:

The technology described in this briefing is Promonitor. It is used to monitor response to biologic therapies.

The innovative aspect is that each sample only needs to be run once, potentially allowing for a higher throughput of tests.

The intended place in therapy would be in addition to current methods of monitoring drug response in people with rheumatoid arthritis.

Promonitor (Grifols–Progenika) is a portfolio of assays, run on an enzyme-linked immunosorbent assay (ELISA) technology platform, that measure drug levels (etanercept, infliximab, infliximab biosimilars, adalimumab, rituximab, golimumab) and their correlating anti‑drug antibodies (anti‑etanercept, anti‑infliximab, anti‑adalimumab, anti‑rituximab, anti‑golimumab). The focus of this briefing is the use of Promonitor tests to monitor response to biologic treatments for rheumatoid arthritis. Monitoring drug response can help determine which drug works best for the patient.

Tofacitinib for moderate to severe rheumatoid arthritis [TA480]

New Guidance from NICE:

Evidence-based recommendations on tofacitinib (Xeljanz) for treating moderate to severe rheumatoid arthritis in adults.

1 Recommendations

1.1 Tofacitinib, with methotrexate, is recommended as an option for treating active rheumatoid arthritis in adults whose disease has responded inadequately to intensive therapy with a combination of conventional disease-modifying anti-rheumatic drugs (DMARDs), only if:

• disease is severe (a disease activity score [DAS28] of more than 5.1) and
• the company provides tofacitinib with the discount agreed in the patient access scheme.

Guideline for the prescription and monitoring of non-biologic Disease-Modifying Anti-Rheumatic Drugs

The mainstay of treatment for inflammatory rheumatic disease involves DMARDs. The last 30 years have seen enormous shifts in the use of DMARDs, with earlier initiation in disease course as well as combination strategies. Many of the drugs used have potential for harm as well as benefit. Appropriate screening prior to DMARD initiation, as well as vigilant monitoring during therapy, are required to minimize the risk of harm. This current guideline supersedes the previous 2008 BSR/BHPR guideline.

Guideline for the management of adults with primary Sjögren’s Syndrome

Primary Sjogren's Syndrome (pSS) is a classic, immune-mediated, condition of unknown aetiology characterized by focal lymphocytic infiltration of exocrine glands 

This guideline reviews the treatment of the glandular and systemic features of pSS The management of the glandular features includes conserving, replacing and stimulating secretions. Systemic features may require system-specific therapy and immunomodulatory treatment. Holistic management is important and many patients benefit from non-pharmacological therapies and general support.

Guideline for the Management of Gout

The British Society for Rheumatology/British Health Professionals in Rheumatology (BSR/BHPR) guideline for the management of gout was published in 2007 [2]. There are four broad reasons why a revised and updated guideline is now required. First, new pharmaceutical treatment options have become available and the evidence base for the efficacy and safety of available drugs has expanded. Second, the incidence, prevalence and severity of gout have increased [1] despite the availability of safe, effective and potentially curative therapy. Third, research studies and audits have consistently shown that fewer than 50% of patients with gout seen in general practice receive urate-lowering therapy (ULT) [22–25] and that many patients with gout being treated with ULT in both primary [1, 26] and secondary care [27, 28] do not achieve reductions of serum uric acid (sUA) levels to the target level recommended in the BSR/BHPR (300 µmol/l) or EULAR (360 µmol/l) guidelines.

Finally, as evidence has accumulated that the provision of information to patients with gout is suboptimal [29] and qualitative studies have begun to define a range of patient and provider barriers to effective care [30–32], preliminary data are emerging that demonstrate that these barriers can be overcome, and outcomes improved, with better provision of information and a package of care based on guideline recommendations [33].

Assessing, managing and monitoring biologic therapies for inflammatory arthritis

RCN's updated fourth edition of the RCN’s guidance on assessing, managing and monitoring biologic therapies for inflammatory arthritis which provides a best practice framework for rheumatology specialist practitioners and the wider health care team involved in supporting the administration, monitoring and delivery of care to patients in a variety of settings.

Baricitinib for moderate to severe rheumatoid arthritis [TA466]

Baricitinib, with methotrexate, is recommended as an option for treating active rheumatoid arthritis Baricitinib for moderate to severe rheumatoid arthritis in adults whose disease has responded inadequately to intensive therapy with a combination of conventional disease-modifying antirheumatic drugs (DMARDs), only if:

• disease is severe (a disease activity score [DAS28] of more than 5.1) and
• the company provides baricitinib with the discount agreed in the patient access scheme.

Baricitinib, with methotrexate, is recommended as an option for treating active rheumatoid arthritis in adults whose disease has responded inadequately to or who cannot have other DMARDs, including at least 1 biological DMARD, only if:

• disease is severe (a DAS28 of more than 5.1) and
• they cannot have rituximab and
• the company provides baricitinib with the discount agreed in the patient access scheme.

Baricitinib can be used as monotherapy for people who cannot take methotrexate because it is contraindicated or because of intolerance, when the criteria in sections 1.1 and 1.2 are met.

• Continue treatment only if there is a moderate response measured using European League Against Rheumatism (EULAR) criteria at 6 months after starting therapy. After an initial response within 6 months, withdraw treatment if at least a moderate EULAR response is not maintained.
• These recommendations are not intended to affect treatment with baricitinib that was started in the NHS before this guidance was published. People having treatment outside these recommendations may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Baricitinib for moderate to severe rheumatoid arthritis - guidance (TA466)

New technology appraisal guidance from NICE on baricitinib (Olumiant) for moderate to severe rheumatoid arthritis in adults.

Baricitinib, with methotrexate, is recommended as an option for treating active rheumatoid arthritis in adults whose disease has responded inadequately to intensive therapy with a combination of conventional disease-modifying antirheumatic drugs (DMARDs), only if:

• disease is severe (a disease activity score [DAS28] of more than 5.1) and
• the company provides baricitinib with the discount agreed in the patient access scheme.

Musculoskeletal ultrasound for diagnosis to confirm or rule out a diagnosis of rheumatoid arthritis

In patients with suspected rheumatoid arthritis, does the use ofmusculoskeletal ultrasound increase the ability ofrheumatologists to confirm or rule out a diagnosis ofrheumatoid arthritis at an earlier stage compared to routinediagnostic assessment? 

Evidence note from Healthcare Improvement Scotland:
There is evidence from two overlapping systematic reviews to support the clinical effectiveness of adding musculoskeletal ultrasound to clinical assessment and laboratory testing to diagnose rheumatoid arthritis at an earlier stage of the disease. Results from three primary studies with methodological weaknesses suggest that musculoskeletal ultrasound can increase rheumatologists’ diagnostic certainty, predict progression to inflammatory arthritis and decrease the time to diagnosis or initiation of DMARD therapy in patients with suspected rheumatoid arthritis.

Hand exercises for patients with rheumatoid arthritis: an extended follow-up of the SARAH randomised controlled trial

BMJ Open 7(4), 2017.  DOI: http://dx.doi.org/10.1136/bmjopen-2016-013121

Participants undertaking the SARAH exercise programme had improved hand function compared with baseline >2 years after randomisation. This was not the case for the control group. However, scores were no longer statistically different between the groups indicating the effect of the programme had diminished over time. This reduction in hand function compared with earlier follow-up points coincided with a reduction in self-reported performance of hand exercises. Further intervention to promote long-term adherence may be warranted.

Collaborating Site in Research: UHCW

Certolizumab pegol for treating rheumatoid arthritis after inadequate response to a TNF-alpha inhibitor

New NICE technology appraisal guidance on using certolizumab pegol (Cimzia) for treating severe active rheumatoid arthritis in adults who have had a tumour necrosis factor-alpha inhibitor.

Existing drugs for rheumatoid arthritis may also improve associated fatigue

NIHR Signal -
Biological treatments work by reducing the joint inflammation and destruction associated with the condition, but to date it has been uncertain if this could affect fatigue.
Fatigue was not a main outcome in any of the included studies in this Cochrane review. The way it was measured and reported varied between studies, making it harder to compare findings.