Patient and public involvement in rheumatic and musculoskeletal research: an idea whose time has firmly come.

Patient and public involvement is an idea whose time has firmly come. It is the views of these Guest Editors that it is the right thing to do morally and improves research quality and applicability.

Patient and public involvement in implementation of evidence-based guidance for musculoskeletal conditions: a scoping review of current advances and gaps.

Advances in musculoskeletal (MSK) research have been successfully curated into widely endorsed evidence-based recommendations and guidelines. However, there continues to exist significant variations in care and quality of care, and the global health and socio-economic burdens associated with MSK conditions continues to increase. Limited accessibility, and applicability of guideline recommendations have been suggested as contributory factors to less than adequate guideline implementation. Since patient and public involvement (PPI) is being credited with increasing relevance, dissemination and uptake of MSK research, the success of guidelines implementation strategies may also be maximised through increasing opportunities for PPI input. We therefore conducted a scoping review of literature to explore PPI in implementation of evidence-based guidance for MSK conditions. A comprehensive search was used to identify relevant literature in three databases (Medline, Embase, Cinahl) and two large repositories (WHO, G-IN), supplemented by grey literature search. Eligibility was determined with criteria established a priori and narrative synthesis was used to summarise PPI activities, contexts, and impact on implementation of MSK related evidence-based guidance across ten eligible studies (one from a low-and middle-income country LMIC). A prevalence of low-level PPI (mainly consultative activities) was found in the current literature and may partly account for current experiences of significant variations and quality of care for MSK patients. The success of PPI in MSK research may be lessened by the oversight of PPI in implementation. This has implications for both high- and low-resource healthcare systems, especially in LMICs where evidence is limited. Patient and public partnership for mobilising knowledge, maximising guideline uptake, and bridging the research-practice gap particularly in low resource settings remain important and should extend beyond PPI in research and guideline dissemination activities only. This review is a clarion call to stakeholders, and all involved, to transform PPI in MSK research into real world benefits through implementation approaches underpinned by patient and public partnerships. We anticipate that this will enhance and drive quality improvements in MSK care with patients and for patients across health and care settings.

Patient educational needs and challenges in psoriatic arthritis.

PURPOSE OF REVIEW: To provide an overview of the recent research publications on educational needs of patients with psoriatic arthritis (PsA) and the associated challenges. RECENT FINDINGS: The rate of good treatment adherence in PsA can be as low as 57.7% and successful patient education can help improve treatment adherence. Also, 78.7% of patients who stopped their disease modifying anti-rheumatic drugs during the first wave of the COVID-19 pandemic did so without the advice of their clinician. In delivering educational needs, the aspects of disease process, treatment, self-help measures, managing pain, movement, psychological and social needs should all be addressed, whilst at the same time, recognising that PsA patients with multidomain disease, are likely to be dealing with more than just pain. Arthritis self-care management education is potentially beneficial, but up to 11% of educational YouTube videos may contain misleading patient opinion and many existing apps do not meet the needs of the patients with PsA. SUMMARY: Significant room for improvement exists in treatment adherence in PsA and patient education addressing the relevant educational needs could assist with this issue. However, patients should be advised to be wary of internet videos and other educational aids that were not created by health professionals.

The impact of COVID-19 on rheumatology practice across Africa.

OBJECTIVES: To identify the changes in rheumatology service delivery across the five regions of Africa from the impact of the COVID-19 pandemic. METHODS: The COVID-19 African Rheumatology Study Group created an online survey consisting of 40 questions relating to the current practices and experiences of rheumatologists across Africa. The CHERRIES checklist for reporting results of internet e-surveys was adhered to. RESULTS: A total of 554 completed responses were received from 20 countries, which include six in Northern Africa, six in West Africa, four in Southern Africa, three in East Africa and one in Central Africa. Consultant grade rheumatologists constituted 436 (78.7%) of respondents with a mean of 14.5 ± 10.3 years of experience. A total of 77 (13.9%) rheumatologists avoided starting a new biologic. Face-to-face clinics with the use of some personal protective equipment continued to be held in only 293 (52.9%) rheumatologists' practices. Teleconsultation modalities found usage as follows: telephone in 335 (60.5%), WhatsApp in 241 (43.5%), emails in 90 (16.3%) and video calls in 53 (9.6%). Physical examinations were mostly reduced in 295 (53.3%) or done with personal protective equipment in 128 (23.1%) practices. Only 316 (57.0%) reported that the national rheumatology society in their country had produced any recommendation around COVID-19 while only 73 (13.2%) confirmed the availability of a national rheumatology COVID-19 registry in their country. CONCLUSION: COVID-19 has shifted daily rheumatology practices across Africa to more virtual consultations and regional disparities are more apparent in the availability of local protocols and registries.

An evaluation of tofacitinib for the treatment of psoriatic arthritis.

Introduction: Psoriatic arthritis (PsA) is a chronic inflammatory condition that is associated with progressive joint destruction and reduced quality of life. Despite the common use of disease-modifying anti-rheumatic drugs (DMARDs) in PsA, their influence has been investigated in a number of studies with conflicting results. There is also concern about their safety and tolerability. Tofacitinib is an orally administered Janus kinase (JAK) inhibitor that has recently been approved for the treatment of PsA by various international regulatory authorities, including the FDA, EMA, and NICE. Areas covered: In this review, the mechanism of action and the pharmacokinetic properties of tofacitinib are discussed. The data from two large phase III clinical studies evaluating the use of tofacitinib in PsA is also discussed in addition to the findings from other relevant studies. Expert opinion: The clinical data demonstrate significant improvement in disease activity in PsA patients using tofacitinib. There is also an acceptable clinical safety profile for the drug. Tofacitinib has various advantages over several existing drug treatments for PsA including an oral route of administration, a short half-life and a fast onset of action. Consequently, we anticipate that tofacitinib will become an increasingly used targeted synthetic DMARD (tsDMARD) for active PsA over the coming years.

Apremilast: a PDE4 inhibitor for the treatment of psoriatic arthritis.

INTRODUCTION: The evidence base for disease-modifying anti-rheumatic drugs used in psoriatic arthritis (PsA) is surprisingly weak, with most having little robust evidence to support their clinical use. Furthermore, there remain safety and tolerability concerns with both these and more recently available biological therapies. Apremilast , a novel, small molecule, represents the first oral therapy specifically developed for PsA. AREAS COVERED: This review describes the pharmacokinetic properties of apremilast and available data demonstrating significant benefits to both clinical and histological features of inflammatory arthritis. The key findings from a large Phase III clinical program will also be discussed, including short- and long-term efficacy outcomes and, importantly, the safety profile. Indications other than PsA will also be briefly reviewed. Given the recent nature of much of the data, published literature as well as information available only in the abstract format are included in this review. EXPERT OPINION: Studies show that treatment with apremilast results in significant improvement in both skin psoriasis and PsA symptoms. Apremilast has been approved by both the United States FDA and European Medicines Agency for treatment of PsA. Use of this medication is recommended in active PsA patients, according to local licensing.

Longterm (52-week) results of a phase III randomized, controlled trial of apremilast in patients with psoriatic arthritis.

OBJECTIVE: To evaluate the efficacy and safety of apremilast, an oral phosphodiesterase 4 inhibitor, over 52 weeks in patients with active psoriatic arthritis (PsA) despite prior treatment. METHODS: Patients were randomized to placebo (n = 168), apremilast 20 mg BID (n = 168), or apremilast 30 mg BID (n = 168). Patients whose swollen and tender joint counts had not improved by ≥ 20% at Week 16 were considered nonresponders and were required to be re-randomized (1:1) to apremilast 20 mg BID or 30 mg BID if they were initially randomized to placebo, or continued their initial treatment of apremilast dose. At Week 24, all remaining patients treated with placebo were re-randomized to apremilast 20 mg BID or 30 mg BID. RESULTS: An American College of Rheumatology 20 (ACR20) response at Week 16 was attained by significantly more patients receiving apremilast 20 mg BID (30.4%, p = 0.0166) or 30 mg BID (38.1%, p = 0.0001) than placebo (19.0%). Among patients receiving apremilast continuously for 52 weeks (n = 254), ACR20 response at Week 52 was observed in 63.0% (75/119, 20 mg BID) and 54.6% (71/130, 30 mg BID) of patients. Response was also maintained across secondary outcomes, including measures of PsA signs and symptoms, skin psoriasis severity, and physical function. The nature, incidence, and severity of adverse events were comparable over the 24-week and 52-week periods. The most common adverse events, diarrhea and nausea, generally occurred early and were self-limited. CONCLUSION: Continuous apremilast treatment resulted in sustained improvements in PsA for up to 52 weeks. Apremilast had an acceptable safety profile and was generally well tolerated. CLINICAL TRIAL REGISTRATION: NCT01172938.

Treatment of psoriatic arthritis in a phase 3 randomised, placebo-controlled trial with apremilast, an oral phosphodiesterase 4 inhibitor.

OBJECTIVES: Apremilast, an oral phosphodiesterase 4 inhibitor, regulates inflammatory mediators. Psoriatic Arthritis Long-term Assessment of Clinical Efficacy 1 (PALACE 1) compared apremilast with placebo in patients with active psoriatic arthritis despite prior traditional disease-modifying antirheumatic drug (DMARD) and/or biologic therapy. METHODS: In the 24-week, placebo-controlled phase of PALACE 1, patients (N=504) were randomised (1:1:1) to placebo, apremilast 20 mg twice a day (BID) or apremilast 30 mg BID. At week 16, patients without ≥20% reduction in swollen and tender joint counts were required to be re-randomised equally to either apremilast dose if initially randomised to placebo or remained on their initial apremilast dose. Patients on background concurrent DMARDs continued stable doses (methotrexate, leflunomide and/or sulfasalazine). Primary outcome was the proportion of patients achieving 20% improvement in modified American College of Rheumatology response criteria (ACR20) at week 16. RESULTS: At week 16, significantly more apremilast 20 mg BID (31%) and 30 mg BID (40%) patients achieved ACR20 versus placebo (19%) (p<0.001). Significant improvements in key secondary measures (physical function, psoriasis) were evident with both apremilast doses versus placebo. Across outcome measures, the 30-mg group generally had higher and more consistent response rates, although statistical comparison was not conducted. The most common adverse events were gastrointestinal and generally occurred early, were self-limiting and infrequently led to discontinuation. No imbalance in major adverse cardiac events, serious or opportunistic infections, malignancies or laboratory abnormalities was observed. CONCLUSIONS: Apremilast was effective in the treatment of psoriatic arthritis, improving signs and symptoms and physical function. Apremilast demonstrated an acceptable safety profile and was generally well tolerated. CLINICAL TRIAL REGISTRATION NUMBER: NCT01172938.

A delphi exercise to identify characteristic features of gout - opinions from patients and physicians, the first stage in developing new classification criteria.

OBJECTIVE: To identify a comprehensive list of features that might discriminate between gout and other rheumatic musculoskeletal conditions, to be used subsequently for a case-control study to develop and test new classification criteria for gout. METHODS: Two Delphi exercises were conducted using Web-based questionnaires: one with physicians from several countries who had an interest in gout and one with patients from New Zealand who had gout. Physicians rated a list of potentially discriminating features that were identified by literature review and expert opinion, and patients rated a list of features that they generated themselves. Agreement was defined by the RAND/UCLA disagreement index. RESULTS: Forty-four experienced physicians and 9 patients responded to all iterations. For physicians, 71 items were identified by literature review and 15 more were suggested by physicians. The physician survey showed agreement for 26 discriminatory features and 15 as not discriminatory. The patients identified 46 features of gout, for which there was agreement on 25 items as being discriminatory and 7 items as not discriminatory. CONCLUSION: Patients and physicians agreed upon several key features of gout. Physicians emphasized objective findings, imaging, and patterns of symptoms, whereas patients emphasized severity, functional results, and idiographic perception of symptoms.