The impact of the COVID-19 pandemic and stringent social distancing measures on health-related quality of life and COVID-19 infection rates in patients with rheumatic disease: a longitudinal analysis through the pandemic.

Objective: The aim was to evaluate the impact of the coronavirus disease 2019 (COVID-19) pandemic and stringent social isolation measures on patients with rheumatic disease (RD) from the beginning of the pandemic (April 2020). Methods: In this UK-based single-centre, prospective, observational cohort study, all RD follow-up patients at our centre were invited by SMS text message in April 2020 to participate in the study. Participants completed questionnaires at four time points between April 2020 and December 2021. We collected demographics, clinically extremely vulnerable (CEV) status, short form 12 mental (MCS) and physical health component scores (PCS) for health-related quality of life, vaccination status, COVID-19 infection rates and incidence of long COVID. Results: We enrolled 1605 patients (female, 69.0%; CEV, 46.5%); 906 of 1605 (56.4%) completed linked responses to our final questionnaire. MCS improved (+0.6, P < 0.05), whereas PCS scores deteriorated (-1.4, P < 0.001) between April 2020 and December 2021. CEV patients had worse mental and physical health scores than non-CEV patients at entry (PCS, 36.7 and 39.3, respectively, P < 0.001; MCS, 40.9 and 43.0, respectively, P < 0.001) and at each time point throughout the study; both mental and physical health outcomes were worse in CEV compared with non-CEV patients (P < 0.001 and P = 0.004, respectively). At study close, 148 of 906 (16.3%) reported COVID infection, with no difference in infection, vaccination or long COVID rates between CEV and non-CEV patients. Conclusions: Mental and physical health in RD patients has changed throughout the pandemic; outcomes for both metrics of health were worse in CEV patients, although there were no differences in infection rates between the groups. These data might assist the understanding and planning of future health-care policy and social restrictions in RD patients. Trial registration: ClinicalTrials.gov, www.clinicaltrials.gov, NCT04542031.

Real-world evidence for subcutaneous infliximab (CT-P13 SC) treatment in patients with ankylosing spondylitis during the coronavirus disease (COVID-19) pandemic: A case series.

The COVID-19 pandemic emphasized the utility of subcutaneous (SC) biologics for pressured healthcare systems. The first SC form of infliximab, CT-P13 SC, provided safe and effective treatment for ankylosing spondylitis in our case series, with increased convenience relative to intravenous treatment benefitting patients both during the pandemic and beyond.

Real-world evidence for subcutaneous infliximab (CT-P13 SC) treatment in patients with psoriatic arthritis during the coronavirus disease (COVID-19) pandemic: A case series.

The COVID-19 pandemic highlighted the benefits of subcutaneous (SC) administration for healthcare systems. The first SC infliximab, CT-P13 SC, was safe and effective for the treatment of psoriatic arthritis. Observed patient preferences for continuing CT-P13 SC suggest that patients receiving IV infliximab should be offered a switch to CT-P13 SC.

Are telephone consultations here to stay in rheumatology?

OBJECTIVES: During the COVID-19 pandemic, face-to-face rheumatology follow-up appointments were mostly replaced with telephone or virtual consultations in order to protect vulnerable patients. We aimed to investigate the perspectives of rheumatology patients on the use of telephone consultations compared with the traditional face-to-face consultation. METHODS: We carried out a retrospective survey of all rheumatology follow-up patients at the Royal Wolverhampton Trust who had received a telephone consultation from a rheumatology consultant during a 4-week period via an online survey tool. RESULTS: Surveys were distributed to 1213 patients, of whom 336 (27.7%) responded, and 306 (91.1%) patients completed all components of the survey. Overall, an equal number of patients would prefer telephone clinics or face-to-face consultations for their next routine appointment. When divided by age group, the majority who preferred the telephone clinics were <50 years old [χ2 (d.f. = 3) = 10.075, P = 0.018]. Prevalence of a smartphone was higher among younger patients (<50 years old: 46 of 47, 97.9%) than among older patients (≥50 years old: 209 of 259, 80.7%) [χ2 (d.f. = 3) = 20.919, P < 0.001]. More patients reported that they would prefer a telephone call for urgent advice (168, 54.9%). CONCLUSION: Most patients interviewed were happy with their routine face-to-face appointment being switched to a telephone consultation. Of those interviewed, patients >50 years old were less likely than their younger counterparts to want telephone consultations in place of face-to-face appointments. Most patients in our study would prefer a telephone consultation for urgent advice. We must ensure that older patients and those in vulnerable groups who value in-person contact are not excluded. Telephone clinics in some form are here to stay in rheumatology for the foreseeable future.

Statin-induced autoimmune necrotizing myositis-A single-center case series highlighting this potentially life-threatening but treatable condition.

Statin-induced autoimmune necrotizing myositis is a rare but important cause muscle weakness. Withdrawal of the statin and steroid treatment alone may be insufficient treatment for SIANM. Targeted immunosuppression may be needed and can be effective.

The current standard of care and the unmet needs for axial spondyloarthritis.

The aim of this article is to explore the benefits and limitations of the established treatments for axial SpA (axSpA), including physiotherapy, NSAIDs, conventional synthetic DMARDs and biologic DMARDs such as TNF inhibitors (TNFis). It also briefly discusses the emerging role of anti-IL-17 therapy, which could be used as a valuable alternative to first-line biologic DMARD treatment or as a second-line treatment for patients who are inadequate responders to TNFi therapy, as evidenced by various studies. Exercise programmes improve health-related quality of life and hydrotherapy improves disease activity and functional parameters in AS. NSAIDs have been proven to substantially relieve symptoms in 70-80% of patients and enhance physiotherapy by reducing pain and stiffness. The role of NSAIDs in preventing radiographic progression remains unclear. The use of conventional synthetic DMARDs (csDMARDs) is limited to peripheral arthritis; there is insufficient evidence to support the use of csDMARDs for axial disease. TNFi therapy reduces the disease activity of axSpA, however, as not all patients respond to treatment in the same way, it is good to have other therapeutic options available. Finally, this article explores the potential for IL-17 inhibition in AS and introduces clinical data for secukinumab, a fully human monoclonal antibody targeting IL-17A.

Long-term effectiveness of tumour necrosis factor-α inhibitor treatment for psoriatic arthritis in the UK: a multicentre retrospective study.

OBJECTIVE: Real-world evidence of the long-term effectiveness of TNF-α inhibitor (TNFi) therapy in patients with PsA is limited. This study was conducted to describe patterns of TNFi therapy and treatment responses in patients with PsA treated in UK clinical practice. METHODS: A multicentre, retrospective, observational cohort study of consenting patients treated with TNFi for PsA with ≥3 years follow-up from first TNFi initiation (observation period) was carried out in 11 UK National Health Service hospitals. Data were collected concerning baseline patient characteristics, PsA-related treatment pathways and TNFi treatment responses (PsA response criteria components: swollen/tender joint counts, physician and patient global assessments). RESULTS: The mean age of patients (n = 141) was 50.3 (s.d.: 12.1) years (50% male). During a median observation period of 4.5 (range: 3.4-5.5) years, patients received a median of one (range: one to five) TNFi. Twelve-week response rates for first TNFi (where available) were as follows: 80% (n = 64/80) for swollen joint counts, 79% (n = 63/79) for tender joint counts, 79% (n = 37/47) for physician global assessments, 69% (n = 41/59) for patient global assessments and 79% (n = 37/47) for PsA response criteria. At the end of the observation period, the proportions of patients remaining on first, second, third and fourth/fifth TNFi were 56, 15, 5 and 3%, respectively; 21% of patients permanently discontinued TNFi therapy. CONCLUSION: Long-term TNFi therapy is generally well tolerated and may be effective; however, after initial TNFi failure, there appears to be progressively less benefit and more adverse effects with successive TNFi switches. Strategies are needed for effective therapy for PsA beyond the first TNFi failure.

Double-blind placebo-controlled trial of etanercept in the prevention of work disability in ankylosing spondylitis.

OBJECTIVES: Etanercept has been shown to be rapidly effective in suppressing disease activity in ankylosing spondylitis (AS). The aim of this study was to determine whether etanercept improves work instability as measured by the Ankylosing Spondylitis Work Instability Scale (AS-WIS). METHOD: Forty patients with active AS who were in work but were work unstable were recruited. Patients were randomised to receive 25 mg etanercept or placebo twice weekly for 12 weeks. The primary outcome was change in AS-WIS at week 12. The AS-WIS is a patient-derived outcome measure which allows stratification of the risk of job loss. Secondary outcomes included clinical outcomes and gait parameters. RESULTS: The mean improvement in AS-WIS score at week 12 was 2.75 in the etanercept group and 0.68 in the placebo group (p=0.125). The risk of job loss decreased for 11 (55%) of the etanercept group compared with 7 (35%) in the placebo group. Conversely, the risk of job loss increased in 3 (15%) of the placebo group compared with 1 (5%) in the etanercept group. There was no statistically significant difference between treatment groups in change in WIS categories (Mann-Whitney U test=0.153, p=0.160). Significant improvement with etanercept was seen at week 12 in clinical outcomes and gait parameters. Etanercept was well tolerated, with no dropouts due to adverse events. CONCLUSION: This small study confirms the efficacy of etanercept on clinical outcome measures in patients with AS and suggests an effect on work instability which needs to be replicated in a larger controlled study.

Reducing work disability in Ankylosing Spondylitis: development of a work instability scale for AS.

BACKGROUND: The Work Instability Scale for Rheumatoid Arthritis (RA-WIS) is established and is used by physicians to identify patients at risk of job loss for rapid intervention. The study objective was to explore the concept of Work Instability (a mismatch between an individual's abilities and job demands) in Ankylosing Spondylitis (AS) and develop a Work Instability Scale specific to this population. METHODS: New items generated from qualitative interviews were combined with items from the RA-WIS to form a draft AS-WIS. Rasch analysis was used to examine the scaling properties of the AS-WIS using data generated through a postal survey. The scale was validated against a gold standard of expert assessment, a test-retest survey examined reliability. RESULTS: Fifty-seven participants who were in work returned the postal survey. Of the original 55 items 38 were shown to fit the Rasch model (chi(2) 37.5; df 38; p 0.494) and free of bias for gender and disease duration. Following analysis for discrimination against the gold standard assessments 20 items remained with good fit to the model (chi(2) 24.8; df 20; p 0.21). Test-retest reliability was 0.94. CONCLUSION: The AS-WIS is a self-administered scale which meets the stringent requirements of modern measurement. Used as a screening tool it can identify those experiencing a mismatch at work who are at risk of job retention problems and work disability. Work instability is emerging as an important indication for the use of biologics, thus the AS-WIS has the potential to become an important outcome measure.

Clinical and imaging efficacy of infliximab in HLA-B27-Positive patients with magnetic resonance imaging-determined early sacroiliitis.

OBJECTIVE: To evaluate the efficacy of infliximab in HLA-B27-positive patients with magnetic resonance imaging (MRI)-determined early sacroiliitis, using both clinical and MRI assessments. METHODS: Forty patients with recent-onset inflammatory back pain, as assessed by the Calin criteria, HLA-B27 positivity, clinical disease activity as measured by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), pain and morning stiffness, and magnetic resonance imaging (MRI)-determined sacroiliac joint bone edema were randomized in a double-blind manner to receive infliximab 5 mg/kg or placebo at 0, 2, 6, and 12 weeks. MRI scans were performed at baseline and 16 weeks and scored by 2 observers (blinded to both the order of the scans and to treatment group), using the Leeds scoring system. Clinical assessments included the BASDAI, the Bath Ankylosing Spondylitis Functional Index (BASFI), the Ankylosing Spondylitis Quality of Life (ASQoL) instrument, the ASsessment in Ankylosing Spondylitis International Working Group criteria (ASAS) for improvement, and markers of inflammation. RESULTS: The mean reduction in the total MRI score from week 0 to week 16 was significantly greater in infliximab-treated patients compared with placebo-treated patients (P = 0.033). On average, significantly more lesions resolved in the infliximab group (P < 0.001), while significantly more new lesions developed in the placebo group (P = 0.004). Significantly greater improvement in the infliximab group versus the placebo group was also observed for changes from week 0 to week 16 in the BASDAI (P = 0.002), BASFI (P = 0.004), and ASQoL (P = 0.007) scores. Responses according to the ASAS criteria for 40% improvement, the ASAS criteria for 20% improvement in 5 of 6 domains, and ASAS partial remission were achieved by 61%, 44%, and 56% of infliximab-treated patients, respectively. Infliximab was well tolerated, and no serious adverse events were observed. CONCLUSION: Infliximab was an effective therapy for early sacroiliitis, providing a reduction in disease activity by week 16. This study is the first to show that infliximab is effective for reducing clinical and imaging evidence of disease activity in patients with MRI-determined early axial spondylarthritis.

Ankylosing spondylitis, HLA-B27 positivity and the need for biologic therapies.

OBJECTIVES: HLA-B27 positivity strongly influences Ankylosing spondylitis (AS) disease susceptibility and phenotype. The aim of this study was to analyse an AS cohort with respect to quality of life (ASQoL), extra-articular disease, markers of disease activity (BASDAI), functional capacity (BASFI), biologic requirement, and the influence of HLA-B27 on these parameters. METHODS: Data recorded in 82 patients included demographics (age, sex), extra-articular disease (GI, ocular, dermatological, GU), cardiac and pulmonary diagnoses. BASDAI, BASFI, ASQoL, joint counts, disease duration and past/present treatment (NSAID, DMARD, steroid and biologic use) were also recorded. RESULTS: 90.2% of the cohort was B27 positive with significantly longer disease duration (17.6 v 6.9 years, p<0.05). BASFI (42.2 v 5.9), BASDAI (3.22 v 1.3), ASQoL (10 v 4), physician assessment of biologic need (24 v 5), steroid (15.7% v 12.5%) and NSAID use (98.6% v 75%) were higher in the B27 positive group, as were ocular (38.9% v 12.5%), pulmonary (4.2% v 0%) and cardiac (4.3% v 0%) features. Negative patients displayed more GI (37.5% v 19.4%), dermatological (25% v 19.7%) and GU (25% v 4.2%) features. Patients satisfying ASAS (AS assessment study group) criteria and receiving biologic therapy were 18.9% (B27 positive group) and 0% (B27 negative group). CONCLUSIONS: AS patients have significantly longer disease duration if B27 positive, higher markers of disease activity, poorer functional status, poorer quality of life, and more extra-articular manifestations. These findings were reflected in the percentage of patients needing biologic therapies.