Intra-Articular Injection of Platelet-Rich Plasma Is More Effective than Hyaluronic Acid or Steroid Injection in the Treatment of Mild to Moderate Knee Osteoarthritis: A Prospective, Randomized, Triple-Parallel Clinical Trial.

Purpose: To prospectively compare the efficacy and safety of intra-articular injections of platelet-rich plasma (PRP) with hyaluronic acid (HA) and glucocorticosteroid (CS) control groups for knee osteoarthritis (KOA) in a randomized, triple-parallel, single-center clinical trial. Methods: A total of 75 patients were randomly assigned to one of three groups receiving a single injection of either leukocyte-poor platelet-rich plasma (25 knees), hyaluronic acid (25 knees), or glucocorticosteroid (25 knees). The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score was collected at baseline and 6, 12, and 26 weeks after treatment. Results: After 6 weeks of PRP administration, a decrease in the mean WOMAC value was observed in all three study groups. Three months after administration, the greatest decrease in the mean WOMAC value was obtained in the PRP group. The results in the HA and CS groups were similar (p = 0.681). In the one-way analysis of variance and post hoc analysis using the HSD Tukey test, a significantly greater improvement was shown by comparing the PRP and CS groups (p = 0.001), and the PRP and HA groups (p = 0.010). After intra-articular injection of CS, the reduction in pain was greatest 6 weeks after administration, and the mean value was the lowest among all groups. During subsequent visits, the value of the pain subscale increased, and after 6 months, it was the highest among the studied groups. Using the Wilcoxon paired test, no PRP effect was found to reduce stiffness at the 6-month follow-up (p = 0.908). Functional improvement was achieved in all groups, i.e., a decrease in the value of this subscale 6 months after administration. The largest decrease was seen in the group that received PRP (p < 0.001) and then in the HA group. The smallest decrease among the investigated methods was shown in the CS group. Conclusions: Intra-articular injections of PRP can provide clinically significant functional improvement for at least 6 months in patients with mild to moderate KOA which is superior to HA or CS injections.

Biosimilar infliximab versus originator in Crohn's disease anti-TNF-α naïve and non-naïve patients.

INTRODUCTION: Data comparing response to originator and biosimilar infliximab in anti-TNF-α naïve and non-naïve Crohn's disease patients is limited. AIM: To assess the efficacy, safety, and tolerability of a biosimilar infliximab in comparison to the originator drug in anti-TNF-α naïve and non-naïve Crohn's disease patients. Data comparing response in those two groups of patients are limited. MATERIAL AND METHODS: This retrospective single-centre study enrolled 168 adult Crohn's disease patients treated for 1 year with infliximab originator or biosimilar. Assessment included achievement of clinical remission (during induction and maintenance therapy and follow-up period - 24 months) and occurrence of adverse events. RESULTS: Forty-seven patients taking infliximab and 68 on biosimilar were anti-TNF-α naïve. There were no differences in clinical remission rate between naïve and non-naïve patients after 1 year of treatment (infliximab - 80.9% and 73.1%, respectively; biosimilar - 79.4% and 74.1%, respectively). The relapse rate during the follow-up period was higher in anti-TNF-α non-naïve patients (p < 0.001) with no significant differences between two groups. Adverse events were more common in anti-TNF-α non-naïve patients with no difference between infliximab and biosimilar groups (13.3% vs. 17.6%, respectively). The infliximab group of anti-TNF-α naïve patients had a higher rate of adverse events compared to the biosimilar (8.1% vs. 1.9%), but it did not reach statistical significance. CONCLUSIONS: This is a study comparing anti-TNF-α naïve and non-naïve patients with Crohn's disease. Relapse rate during follow-up was significantly higher in anti-TNF-α non-naïve patients, but with no significant differences between originator and biosimilar.

The efficacy and safety of the biosimilar product (Inflectra®) compared to the reference drug (Remicade®) in rescue therapy in adult patients with ulcerative colitis.

INTRODUCTION: The biosimilar product Inflectra® has been approved by the European Medicine Agency (EMA) for the same indications as its reference drug, infliximab, based on studies in patients with rheumatic diseases. Thus far, there have not been enough data regarding its efficacy and safety in ulcerative colitis (UC). AIM: To assess the efficacy and safety of the biosimilar product Inflectra® in comparison with its reference biological agent (Remicade®) in rescue therapy in adult patients presenting with severe exacerbation of UC, as well as to evaluate recurrence rate during a 6-month observation after finish of treatment. MATERIAL AND METHODS: In a single-centre retrospective study, a cohort of 83 adult patients with severe UC treated at the Department of Gastroenterology with Inflammatory Bowel Diseases Subdivision of the Central Clinical Hospital of MSWiA, Warsaw was investigated. All patients received three induction doses of Remicade® (28 individuals) or Inflectra® (55 individuals) based on the same criteria of the National Health Fund (NFZ) Therapeutic Program (total Mayo score > 6). Activity of the disease was evaluated on the Mayo scale at qualification, after finishing the rescue treatment (after 14 weeks), and after a 6-month observation period. In all patients, sigmoidoscopy was performed at qualification and after induction (after three doses). RESULTS: The studied groups were similar with respect to age and sex distribution, duration of the disease, extent of the disease (left-sided type, pancolitis), additional pharmacotherapy, and smoking. Clinical response following three induction doses was noted in 81% of patients receiving Remicade® compared to 77% receiving the biosimilar product, Inflectra® (NS); while clinical remission was observed in 42% receiving Remicade® and 32% receiving Inflectra® (NS), respectively. Endoscopic remission assessed as 0 on the Mayo scale was achieved in 4 (15%) patients on Remicade® and in 7 (13%) patients on Inflectra® (p = 0.45). Relapse occurred in 68% of all patients, while 51% presented with exacerbation of the disease 3 months after finishing biological treatment. In 93%, exacerbation occurred within 12 months. The recurrence rate was similar in both groups (75% with Remicade®, 64% with Inflectra®, respectively). Side effects occurred with similar frequency in both groups. CONCLUSIONS: In the study, it was established that the biosimilar drug (Inflectra®) has a similar efficacy and safety as the reference biological agent (Remicade®), not only in rescue therapy, but also during a 6-month observation period in adult patients with severe UC. Low mucosal healing rate in both groups and high recurrence rate of the disease soon after finishing induction treatment indicate the need for prolonged therapy with infliximab in patients with severe UC.

The effect of cyclic rifaximin therapy on symptoms of diverticular disease from the perspective of the gastroenterology outpatient clinic: a "real-life" study.

INTRODUCTION: Symptomatic uncomplicated diverticular disease of the colon (SUDD) is one of the most common diseases with which patients present to a gastroenterologist. Mild forms of diverticulitis can also be treated using rifaximin. Although numerous randomised controlled trials have already demonstrated the efficacy of rifaximin therapy, there is still a lack of data from daily medical practice. AIM: To assess the effect of rifaximin on the symptoms of diverticular disease (SUDD and mild diverticulitis) in patients undergoing routine treatment in gastroenterology outpatient clinics in Poland. MATERIAL AND METHODS: The retrospective study included 142 patients with a diagnosis of SUDD and mild diverticulitis, with a mean age of 60-69 years (41%), of whom 65% were women. Patients underwent three cycles of rifaximin therapy at a dose of 2 × 400 mg daily for 7 days over 3 consecutive months. Survey data were collected during monthly clinic appointments using a questionnaire completed by 48 gastroenterologists, and in selected cases standard inflammatory parameters were also determined. RESULTS: After just one cycle of therapy a significant reduction in disease symptoms was observed (abdominal pain, abdominal tenderness, bloating, disturbances in bowel habit), defined over a scale of 0-3 points. The mean intensity of symptoms decreased from 1.7 ±0.7 to 0.8 ±0.3 points (with a maximum symptom intensity of 3.0 points). After three cycles, the severity of symptoms decreased markedly to an average of 0.3 ±0.1, and as many as 75% of patients reported no abdominal pain (previously the percentage was only 4%). These differences were statistically significant, p < 0.001. The decrease in inflammatory parameters (white blood cell count, C-reactive protein and erythrocyte sedimentation rate) was statistically significant. CONCLUSIONS: Rifaximin is highly effective in the symptomatic relief of uncomplicated diverticular disease of the large bowel, and it is also effective in the treatment of mild forms of diverticulitis. Although the effects were already visible after the first cycle of therapy, the highest efficacy was obtained after three cycles of therapy. Rifaximin can be successfully used in routine medical practice.

Rapid fecal calprotectin test for prediction of mucosal inflammation in ulcerative colitis and Crohn disease: a prospective cohort study.

INTRODUCTION Fecal calprotectin (FC) is a well­established biomarker of intestinal inflammation in Crohn disease (CD) and ulcerative colitis (UC). However, standard laboratory methods are time­consuming and not always useful in clinical practice. OBJECTIVES We analyzed the efficacy of a rapid bedside FC test to detect disease flares in a hospital setting. We also assessed the influence of disease location on the diagnostic accuracy of FC.  PATIENTS AND METHODS This prospective study included 140 patients (46 with UC; 94 with CD). FC was measured by an enzyme­linked immunosorbent assay (ELISA) and by the rapid Quantum Blue® test. Endoscopic activity was assessed using the Mayo endoscopic subscore or the Simple Endoscopic Score for Crohn's Disease (SES­CD).  RESULTS FC levels highly correlated with endoscopic activity in CD (area under the receiver operating characteristic curve [AUC], 0.83) and UC (AUC, 0.80), with the cut­off values of 238.5 µg/g and 499 µg/g, respectively. FC levels increased dynamically even with early signs of inflammation both in CD (SES­CD, 4-10 vs 0 points: 252 vs 100.0 µg/g; P = 0.02) and UC (Mayo subscore, 1 vs 0 points: 323.3 vs 100.0 µg/g; P <0.001). In UC, FC levels were lower in proctitis than in left­sided UC and pancolitis (340.0, 500.0, and 421.5 µg/g, respectively), but the differences were not significant. In CD, lower FC values were observed in isolated small bowel disease. CONCLUSIONS FC levels increased dynamically even with mild signs of intestinal inflammation. The rapid Quantum Blue® test presents a potential alternative to the time­consuming ELISA, because its diagnostic accuracy is not influenced by disease location. It may be useful in the hospital setting, providing faster diagnosis and allowing cost reduction by lowering the number of endoscopic procedures.

Management of anemia in inflammatory bowel disease: a challenge in everyday clinical practice.

Anemia is the most common extraintestinal manifestation and complication of inflammatory bowel disease (IBD). Its etiology is multifactorial and mostly is a combination of iron deficiency anemia (IDA) and chronic anemia (ACD). Because of its high incidence in patients with IBD and its influence on their quality of life, regular screening is recommended. In case of IDA type of medication and route of administration should be determined by many factors such as general condition of the patient, IBD activity or anemia severity. Intravenous iron supplementation is the preferred route but may be associated with phosphate drop or even severe hypophosphatemia (HP). The mechanism of HP related to the intravenous iron infusions is not clearly known yet, but it might be related to the change of FGF-23 levels. What more not all parenteral forms of iron are equal and some may have a higher risk of HP than others.

Delayed diagnosis of human immunodeficiency virus infection in a patient with non-specific neurological symptoms and pancytopenia: a case report.

INTRODUCTION: Both non-specific presentation and asymptomatic course of human immunodeficiency virus infection lead to undiagnosed long-term persistence of the virus in a patient's organism. CASE PRESENTATION: Here, we present a case of a 31-year-old Caucasian man with non-specific neurological symptoms and pancytopenia, who was referred to an internal medicine ward for further diagnosis. Upon admission to our hospital, he denied any past risky behaviors and refused to have his blood collected for human immunodeficiency virus testing. Later, he eventually provided consent to conduct the human immunodeficiency virus test which turned out to have a positive result. The overall clinical pattern indicated an advanced-stage of acquired immunodeficiency syndrome, which contrasted with the history he had provided. CONCLUSIONS: This case report indicates the need to consider human immunodeficiency virus/acquired immunodeficiency syndrome diagnosis in patients with non-specific neurological and hematological disorders. Our report also demonstrates difficulties that can be experienced by the physician while trying to obtain both a clear history and consent to perform human immunodeficiency virus testing.

Biomarkers in management of inflammatory bowel disease.

In recent years the use of faecal and serologic biomarkers has been evaluated in the diagnosis and management of inflammatory bowel disease (IBD). Faecal calprotectin (FC) has been proposed as a surrogate marker for intestinal inflammation; elevated concentrations in IBD patients have been confirmed in numerous studies. Already available rapid calprotectin tests help to differentiate between IBD and irritable bowel syndrome. Faecal calprotectin greatly correlates with endoscopic activity scales and reflects the mucosal healing; thus in patients in clinical remission high levels of it correlate with increased risk of disease relapse in the following 12 months. Adapting the calprotectin assay as a screening test before colonoscopy enables a significant reduction in endoscopic procedures. ANCA/ASCA antibodies have been used in IBD diagnosis and to distinguish CD from ulcerative colitis (UC). Lactoferrin and S100A12 protein were also used to assess the disease activity. This review aims to present the actual potential of biomarker assays for faster diagnosis of IBD and their ability to monitor the disease course, predict exacerbations and improve the way IBD is managed.