Upadacitinib for the Treatment of Rheumatoid Arthritis: An Extensive Review.

OBJECTIVES: To review the characteristics, efficacy, safety, pharmacoeconomics, and place in therapy of upadacitinib, a Janus kinase (JAK) inhibitor, in the treatment of rheumatoid arthritis (RA). DATA SOURCES: PubMed (January 2003-May 2022) was searched using upadacitinib and ABT-494. STUDY SELECTION AND DATA EXTRACTION: Human studies published in peer-reviewed publications in English were the primary sources for efficacy and safety data. DATA SYNTHESIS: In randomized, double-blind, controlled clinical studies, upadacitinib demonstrated statistically significant improvement in RA symptoms as monotherapy and in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) when compared with csDMARD monotherapy or to adalimumab or abatacept in combination with csDMARD therapy in patients with RA. American College of Rheumatology 20% response rates were 68% to 79% for upadacitinib monotherapy and 64% to 84% for upadacitinib plus csDMARD therapy, compared with 28% to 59% for csDMARD-only therapy and 63% to 74% for biologic DMARD (bDMARD) plus csDMARD therapy. Long-term extension studies demonstrated similar findings. Upadacitinib had similar rates of serious infections, herpes zoster, major cardiovascular events, and venous thromboembolic events as other JAK inhibitors. Upadacitinib was similar in cost to tofacitinib and twice as high as baricitinib based on current estimated costs to patients, but actual costs may vary. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: Upadacitinib is an alternative therapy to other JAK inhibitors and bDMARDs in patients with moderate to severe RA who have had an inadequate response to a tumor necrosis factor inhibitor alone or in combination with a csDMARD. CONCLUSIONS: Upadacitinib is an effective JAK inhibitor for use in RA.

Abaloparatide: Review of a Next-Generation Parathyroid Hormone Agonist.

OBJECTIVE: To review the efficacy, safety, and economics of abaloparatide in the treatment of postmenopausal osteoporosis. DATA SOURCES: PubMed (1966 to October 2017), Clinicaltrials.gov (October 2017), and Scopus (1970 to October 2017) were searched using abaloparatide, Tymlos, BA058, PTHrP 1-34 analog, and parathyroid hormone-related peptide 1-34 analog. STUDY SELECTION AND DATA EXTRACTION: Human studies published in peer-reviewed publications in English were the primary sources for efficacy, safety, and economic data. DATA SYNTHESIS: In the 2 randomized, published clinical studies of 24 weeks and 18 months duration, bone mineral density changes were higher for abaloparatide (lumbar spine, 6.7%-11.2%; femoral head, 3.1%-3.2%; total hip, 2.6%-4.2%) compared with placebo (lumbar spine, 0.6%-1.6%; femoral head, -0.4% to 0.8%; total hip, -0.1% to 0.4%; P < 0.05) and compared with teriparatide in the 24-week study (total hip 2.6% vs +0.5%, P < 0.05). New vertebral and nonvertebral fractures occurred in 0.6% and 2.7% of patients on abaloparatide compared with 4.2% and 4.7% on placebo in the 18-month study ( P < 0.05). Abaloparatide appears to have a somewhat higher risk for adverse effects, discontinuation as a result of adverse effects, and serious or severe adverse effects than teriparatide, but teriparatide has a higher risk for hypercalcemia. Pharmacoeconomic modeling appears to favor abaloparatide if differences in efficacy and cost are maintained. CONCLUSION: Abaloparatide, which has less effect on osteoclasts, is an alternative to teriparatide in patients with postmenopausal osteoporosis who are at high risk for fractures or who have failed antiresorptive therapy based on initial clinical studies and economic modeling.

Sarilumab: Review of a Second IL-6 Receptor Antagonist Indicated for the Treatment of Rheumatoid Arthritis.

Major Objectives: To review the efficacy, safety, and economics of sarilumab, an interleukin-6 (IL-6) receptor antagonist, in the treatment of rheumatoid arthritis (RA). DATA SOURCES: PubMed (1966 to January 2018), Clinicaltrials.gov (January 2018), and Scopus (1970 to January 2018) were searched using sarilumab, Kevzara, REGN88, and SAR153191. STUDY SELECTION AND DATA EXTRACTION: Human studies published in peer-reviewed publications in English were the primary sources for efficacy and safety. DATA SYNTHESIS: Data from randomized, double-blind, controlled, published clinical studies weeks demonstrated statistically significantly higher American College of Rheumatology (ACR) 20, ACR50, and Disease Activity Score-28 (DAS28) remission response rates and improvements in DAS28 and Health Assessment Questionnaire-Disability Index scores for sarilumab monotherapy versus adalimumab monotherapy (P < 0.05) and for sarilumab versus placebo in patients receiving methotrexate or other conventional synthetic disease-modifying antirheumatic drugs (DMARDs); P < 0.05. The ACR20 and ACR50 response rates were, respectively, 56-72% and 35-46% for sarilumab, 58% and 30% for adalimumab, and 33-34% and 15-18% for placebo. DAS28 remission rates were 20-34% for sarilumab, 7% for adalimumab, and 7-10% for placebo. Sarilumab has a higher risk for neutropenia than tocilizumab, the other IL-6 inhibitor, but a lower risk for dyslipidemia, injection site reactions, and gastrointestinal perforation. The acquisition costs of sarilumab are expected to be similar to those of most other biologic DMARDs. CONCLUSION: Sarilumab is an alternative to biologic DMARDs or targeted synthetic DMARDs in patients with moderate to severely active RA who have not responded adequately to prior conventional synthetic DMARDs or tumor necrosis factor-α inhibitors.

Dentists and Pharmacists: Paradigm Shifts and Interprofessional Collaborative Practice Models.

Collaborations between dentists and pharmacists have the potential to improve patient care; however, there are limited examples in practice of interprofessional models between these disciplines. The purpose of this article is to explore the current relationship between dentists and pharmacists and to propose new models of interprofessional collaboration that target improvements in patient care.

Tofacitinib: The First Janus Kinase (JAK) inhibitor for the treatment of rheumatoid arthritis.

OBJECTIVE: To review the pharmacology, pharmacokinetics, efficacy and safety, dosage administration, and adverse effects of tofacitinib for rheumatoid arthritis (RA) treatment. DATA SOURCES: Primary sources of information were obtained from clinical studies, which were identified through PubMed (1966 to June 2013) and International Pharmaceutical Abstracts (1970 to March 2013) using terms: tofacitinib, tasocitinib, CP-690550, and CP-690,550. Information was used from tofacitinib package insert, guidelines, and published abstracts from the American College of Rheumatology (ACR) and the European League Against Rheumatism. STUDY SELECTION AND DATA EXTRACTION: Data search was limited to include publications in English language and from human subjects. DATA SYNTHESIS: Tofacitinib is the first oral Janus kinase inhibitor indicated for treatment of moderate to severe RA. Tofacitinib demonstrated efficacy and safety comparable to other disease-modifying antirheumatic drugs (DMARDs). Tofacitinib was efficacious in RA patients, indicated by achievements of ACR20, ACR50, and ACR70 criteria. Similar improvements were observed in patients who met remission criteria based on the Disease Activity Scores 28 criteria and quality of life as measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI). Tofacitinib was associated with infections and malignancies; and elevations in serum creatinine and lipids were observed. Drug interactions with inducers and inhibitors of the cytochrome P-450 3A4 and 2C9 isoenzymes were reported. CONCLUSIONS: Tofacitinib is an oral treatment option for RA patients who have inadequate response or intolerance to methotrexate. Postmarket surveillance will provide further insight to tofacitinib's role in RA therapy, especially in patients who may require different types of combination therapy with DMARDS.

2020 rankings for US PharmD programs, research, and overall quality.

Background: US News and World Report (USNWR) publishes well-known rankings of graduate health programs. Medicine and nursing are ranked with weighted metrics using multiple criteria, and medical schools are ranked separately according to their focus (research or primary care). USNWR pharmacy school rankings are based on a single-question peer perception survey. Objective: The objective of this study was to develop a simple, transparent framework to rank US colleges and schools of pharmacy in overall quality and separately based on program quality and research quality, using data that are readily available to the academy. Methods: Data for three education quality and four research quality metrics were obtained for 2020. Each metric was standardized and ranked, and then each set was summed to determine separate ranks for education and research. Education and research scores were combined using equal weights to provide a single rank for overall quality. A sensitivity analysis was performed to determine the effect of assigning higher proportionate value to education, similar to USNWR medical school rankings. Results: Distinct ranks were produced for education, research, overall (education: research) 50:50, and overall 60:40. Sensitivity analysis suggests the more disproportionately the education and research factors are weighted, the more ranks change. Mid-ranked schools were most impacted when weightings changed due to relative strength in one factor and relative weakness in the other. When weighted 60:40, nine (7%) mid-ranked programs improved in rank, while 11 (11%) worsened in rank compared to the 50:50 model. Conclusion: Separately ranking education and research can highlight the diverse strengths of pharmacy schools. The proposed model is based on easily obtainable data and is easily reproducible, allowing for annual rankings. These rankings may be used by PharmD and PhD applicants when selecting schools and by pharmacy schools to benchmark true and aspirational peers.

A Pathway to Professional Identity Formation: Report of the 2020-2021 AACP Student Affairs Standing Committee.

EXECUTIVE SUMMARY Professional identity formation (PIF) involves internalizing and demonstrating the behavioral norms, standards, and values of a professional community, such that one comes to "think, act and feel" like a member of that community. Professional identity influences how a professional perceives, explains, presents and conducts themselves. This report of the 2020-2021 AACP Student Affairs Standing Committee (SAC) describes the benefits of a strong professional identity, including its importance in advancing practice transformation. Responding to a recommendation from the 2019-2020 SAC, this report presents an illustrative and interpretative schema as an initial step towards describing a pharmacist's identity. However, the profession must further elucidate a universal and distinctive pharmacist identity, in order to better support pharmacists and learners in explaining and presenting the pharmacist's scope of practice and opportunities for practice change. Additionally, the report outlines recommendations for integrating intentional professional identity formation within professional curricula at colleges and schools of pharmacy. Although there is no standardized, single way to facilitate PIF in students, the report explores possibilities for meeting the student support and faculty development needs of an emerging new emphasis on PIF within the Academy.

Pharmacists opinions of the value of specific applicant attributes in hiring decisions for entry-level pharmacists.

OBJECTIVE: The Hiring Intent Reasoning Examination (HIRE) was designed to (1) explore the relative value of applicant-specific attributes evaluated during the hiring of entry-level pharmacists; (2) examine how each of these attributes influences hiring decisions; and (3) identify which attributes practicing pharmacists perceive as most and least valuable. METHODS: An electronic questionnaire was developed and sent to 36,817 pharmacists; 3723 (11%) responded representing a broad cross-section of practice settings and job roles. Forty-eight attributes were analyzed, 24 character traits and 24 markers of academic success. Respondents identified: 1) the relative importance the possession of each attribute would play in the decision to hire an applicant; 2) the relative importance the lack of possession of the attribute would play on the decision to hire an applicant; 3) the 10 most important attributes used when considering an applicant, and; 4) the 10 least important attributes used when considering an applicant. After investigating the relative importance of the 48 traits, a factor analysis to further group the traits was undertaken. RESULTS: Character traits were consistently ranked higher than academic traits, both in importance and as more likely to effect the hiring decision. Additionally, "the top ten most important attributes" were dominated by character traits and "the top ten least important attributes" used in the hiring of an entry-level pharmacist were dominated by the academic traits. A factor analysis provided further evidence of the distinction of the character traits from the academic success markers. CONCLUSION: When selecting employees from a pool of qualified applicants, the most important attributes used in hiring decision relate to the character of the pharmacist. The results are similar across all practice settings and types of respondents completing the survey.

Development, Implementation and Assessment of a Comprehensive Strategic Plan in a School of Pharmacy.

Objective. To develop, implement and assess a strategic plan and its process within a school of pharmacy. Methods. The process for developing the strategic plan included five phases: designing and scanning by a planning committee; divergent thinking with input from key internal and external stakeholders who shared their vision for the school; convergent planning in which faculty members helped to prioritize the clusters, goals, and metrics that had been identified; refining ideas into strategies; and assessment, during which metrics were aligned with assessment plans and data were collected and analyzed. Results. The completed strategic plan had five broad strategies, 20 specific goals, and 90 associated metrics. The plan was implemented with engagement by all major stakeholders in the program. Reallocation of existing resources and generation of new resources were key in making progress. The assessment, which was conducted three years after implementation of the strategic plan, found that each strategy had affected the school's mission to provide an exemplary educational experience for students and to advance the institution. Conclusion. The strategic plan provided direction and focus to meet the challenges of continuing to advance the school. The keys for success in strategic planning are having a well-defined process, involving all faculty members and other key stakeholders, implementing the plan, and routinely assessing progress in meeting the strategic goals.

Characterization of Use of the Pharmacy Curriculum Outcomes Assessment Across Accredited Colleges of Pharmacy.

Objective. To characterize use of the Pharmacy Curriculum Outcomes Assessment (PCOA) in terms of timing, manner of delivery, and application of the results by accredited colleges of pharmacy. Methods. Accredited pharmacy programs were surveyed regarding PCOA administration, perceived benefits, and practical application of score reports. Survey items were comprised of new items developed from a literature review and items from prior studies. The survey addressed five domains: program demographics, administration, student preparation, use of results, and recommendations to improve the utility of the PCOA. Results. Responses were received from 126 of 139 (91%) surveyed programs. The majority of respondent programs administered PCOA in one session on a single campus. Most indicated PCOA results had limited use for individual student assessment. Almost half reported that results were or could be useful in curriculum review and benchmarking. Considerable variability existed in the preparation and incentives for PCOA performance. Differences in some results were found based on prior PCOA experience and between new vs older programs. Open-ended responses provided suggestions to enhance the application and utility of PCOA. Conclusion. The intended uses of PCOA results, such as for student assessment, curricular review, and programmatic benchmarking, are not being implemented across the academy. Streamlining examination logistics, providing additional examination-related data, and clarifying the purpose of the examination to faculty members and students may increase the utility of PCOA results.

Training Students to Address Vaccine Hesitancy and/or Refusal.

Objective. To determine the impact of a vaccine hesitancy learning unit on student knowledge, attitudes, and ability to address vaccine hesitancy and/or refusal. Methods. The learning unit consisted of two standardized patient simulation encounters performed one week apart. A 13-item attitudes survey was administered prior to the simulations to determine student confidence and knowledge regarding vaccine hesitancy. Students then participated in an encounter with a simulated patient who assessed the students' abilities using a 16-item grading rubric related to the art of the rhetoric, communication skills, and social, emotional competence. Post-simulation, students received feedback, completed a self-reflection exercise, and received formal coursework on addressing vaccine hesitancy. The following week, students participated in a second simulated patient encounter and thereafter completed the same attitudes and satisfaction surveys. Results. There were 203 students who went through the learning unit, with 180 (88.6% response rate) completing all the survey tools. The results showed significant improvements in all 16 items of the assessment rubric. On the pre/post attitudes questions, 9 out of 13 items showed significant improvement. Gains were largest for knowledge on the use of thimerosal as a preservative, speaking about how vaccines will not overwhelm a child's immune system, and knowledge about vaccinations not overwhelming a child's immune system. Overall, 94% of students were satisfied with the learning unit. Conclusion. This learning unit was effective in improving student confidence and ability to address vaccine hesitancy.

Update on abatacept: a selective costimulation modulator for rheumatoid arthritis.

OBJECTIVE: To review and update the pharmacology, pharmacokinetics, safety, precautions, efficacy, and use of abatacept for rheumatoid arthritis (RA). DATA SOURCES: Studies and abstracts were identified through MEDLINE, International Pharmaceutical Abstracts, Cochrane databases, and Science Citation Index (1990-April 2007). Key search terms included abatacept, CTLA4-Ig, and BMS 1888667. Information available only in abstract form was retrieved from national and international rheumatology associations. Additional data were obtained from the manufacturer. STUDY SELECTION AND DATA EXTRACTION: All available animal and human studies describing the pharmacology of abatacept and human studies describing the pharmacokinetics, pharmacodynamics, efficacy, safety, adverse events, and precautions of abatacept were included. DATA SYNTHESIS: Abatacept significantly improves the signs and symptoms of moderate-to-severe RA in patients who experienced an inadequate response to methotrexate or antitumor necrosis factor-alpha inhibitors. By month 12, approximately 50% of patients achieved remission (defined as a disease activity score <2.6) that was maintained until at least 24 months of therapy. The most common adverse events include headache, upper respiratory tract infections, nausea, and nasopharyngitis. Rare but serious adverse events include serious infections and malignancy. CONCLUSIONS: Abatacept has documented efficacy and safety in patients with inadequate responses to methotrexate and antitumor necrosis factor agents in both short- and long-term studies. Additional clinical trial and postmarketing evidence is necessary to understand the long-term safety, efficacy, economics, and role of abatacept in clinical practice.

Pharmacists' Opinions of the Value of CAPE Outcomes in Hiring Decisions.

Objective. The Hiring Intent Reasoning Examination (HIRE) was designed to explore the utility of the CAPE 2013 outcomes attributes from the perspective of practicing pharmacists, examine how each attribute influences hiring decisions, and identify which of the attributes are perceived as most and least valuable by practicing pharmacists. Methods. An electronic questionnaire was developed and distributed to licensed pharmacists in four states to collect their opinions about 15 CAPE subdomains plus five additional business related attributes. The attributes that respondents identified were: necessary to be a good pharmacist, would impact hiring decisions, most important to them, and in short supply in the applicant pool. Data were analyzed using statistical analysis software to determine the relative importance of each to practicing pharmacists and various subsets of pharmacists. Results. The CAPE subdomains were considered necessary for most jobs by 51% or more of the 3723 respondents (range, 51% to 99%). The necessity for business-related attributes ranged from 21% to 92%. The percentage who would not hire an applicant who did not possess the attribute ranged from 2% to 71.5%; the percentage who considered the attribute most valuable ranged from 0.3% to 35%; and the percentage who felt the attribute was in short supply ranged from 5% to 36%. Opinions varied depending upon gender, practice setting and whether the pharmacist was an employee or employer. Conclusion. The results of this study can be used by faculty and administrators to inform curricular design and emphasis on CAPE domains and business-related education in pharmacy programs.

Impact of tofacitinib on patient outcomes in rheumatoid arthritis - review of clinical studies.

Rheumatoid arthritis is a chronic, progressive autoimmune disease associated with inflammation and destruction of joints and systemic effects, which result in significant impact on patient's quality of life and function. Tofacitinib was approved for the treatment of rheumatoid arthritis in the USA in 2012 and subsequently in other countries, but not by the European Medicines Agency. The goal of this review was to evaluate the impact of tofacitinib on patient-reported and patient-specific outcomes from prior clinical studies, focusing on quality of life, functionality, pain, global disease assessment, major adverse consequences, and withdrawals. A total of 13 reports representing 11 clinical studies on tofacitinib in rheumatoid arthritis were identified through PubMed and reference lists in meta-analyses and other reviews. Data on improvements in patient-driven composite tools to measure disease activity in rheumatoid arthritis, such as the Health Assessment Questionnaire, served as a major outcome evaluated in this review and were extracted from each study. Additional data extracted from those clinical studies included patient assessment of pain (using a 0-100 mm visual analog scale), patient global assessment of disease (using a 0-100 mm visual analog scale), patient withdrawals, withdrawals due to adverse effects or lack of effect, and risk of serious adverse effects, serious infections, and deaths. Tofacitinib 5 mg bid appears to have a favorable impact on patient outcomes related to efficacy and safety when compared with baseline values and with comparator disease-modifying antirheumatic drugs and placebo. Improvements were seen in the composite and individual measures of disease activity. Serious adverse effects, other adverse consequences, overall withdrawals, and withdrawals due to adverse effects and lack of efficacy are similar or more favorable for tofacitinib versus comparator disease-modifying antirheumatic drugs and placebo. At this point, tofacitinib appears to have an important role in the treatment of rheumatoid arthritis through improvement in these patient outcomes. However, it may require years of additional clinical studies and postmarketing surveillance to fully characterize the benefit-to-risk ratio of tofacitinib in a larger and diverse patient population.

The 2016 ACCP Pharmacotherapy Didactic Curriculum Toolkit.

The 2016 American College of Clinical Pharmacy (ACCP) Educational Affairs Committee was charged with updating and contemporizing ACCP's 2009 Pharmacotherapy Didactic Curriculum Toolkit. The toolkit has been designed to guide schools and colleges of pharmacy in developing, maintaining, and modifying their curricula. The 2016 committee reviewed the recent medical literature and other documents to identify disease states that are responsive to drug therapy. Diseases and content topics were organized by organ system, when feasible, and grouped into tiers as defined by practice competency. Tier 1 topics should be taught in a manner that prepares all students to provide collaborative, patient-centered care upon graduation and licensure. Tier 2 topics are generally taught in the professional curriculum, but students may require additional knowledge or skills after graduation (e.g., residency training) to achieve competency in providing direct patient care. Tier 3 topics may not be taught in the professional curriculum; thus, graduates will be required to obtain the necessary knowledge and skills on their own to provide direct patient care, if required in their practice. The 2016 toolkit contains 276 diseases and content topics, of which 87 (32%) are categorized as tier 1, 133 (48%) as tier 2, and 56 (20%) as tier 3. The large number of tier 1 topics will require schools and colleges to use creative pedagogical strategies to achieve the necessary practice competencies. Almost half of the topics (48%) are tier 2, highlighting the importance of postgraduate residency training or equivalent practice experience to competently care for patients with these disorders. The Pharmacotherapy Didactic Curriculum Toolkit will continue to be updated to provide guidance to faculty at schools and colleges of pharmacy as these academic pharmacy institutions regularly evaluate and modify their curricula to keep abreast of scientific advances and associated practice changes. Access the current Pharmacotherapy Didactic Curriculum Toolkit at http://www.accp.com/docs/positions/misc/Toolkit_final.pdf.

Belimumab: review of use in systemic lupus erythematosus.

BACKGROUND: Belimumab, a monoclonal antibody that inhibits B-lymphocyte stimulating protein, was the first biologic agent approved for, and the first drug approved in 55 years for, the treatment of systemic lupus erythematosus (SLE) by the US Food and Drug Administration (FDA). OBJECTIVE: This article reviews the current research on belimumab and provides recommendations on its use in the treatment of SLE. METHODS: The Cochrane Library, EBSCO, IPA, MEDLINE, and SCOPUS were searched for research published from January 2000 to November 2011, using the search terms belimumab, Benlysta, and Lympho-Stat B. Selection criteria included peer-reviewed original research articles on the pharmacology, pharmacokinetic properties, drug interactions, and clinical efficacy and tolerability of belimumab in the treatment of SLE. Abstracts from the annual meetings of major rheumatology medical organizations and societies were searched and reviewed for new content. Additional information on belimumab was obtained from the manufacturer, from the FDA, and from other sources. MEDLINE was also used to select clinical studies and therapeutic guidelines on SLE therapy. RESULTS: The literature search identified 1 Phase II and 2 Phase III studies that compared belimumab (1, 4, and 10 mg/kg/dose IV on days 0, 14, and 28; then every 28 days) to placebo in patients with active SLE on concurrent therapies. Patients with active lupus nephritis or neuropsychiatric lupus were excluded. In a Phase II, 52-week study, 24-week mean Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) scores were decreased by 19.5% with belimumab versus 17.2% with placebo (P = NS). Median time to first flare was 67 days with belimumab versus 83 days with placebo (P = NS). In seropositive patients, 52-week mean SELENA-SLEDAI scores were decreased by 28.8% with belimumab versus 14.2% with placebo (P < 0.05), and physician's global assessment scores were improved by 32.7% with belimumab versus 10.7% with placebo (P < 0.05). Two Phase III studies were performed in seropositive SLE patients. In a Phase III, 52-week study, the rates of response (a reduction of ≥4 points on the SLE Response Index [SRI]) at week 52 were 51% and 58% with belimumab 1 and 10 mg/kg/dose, respectively, versus 44% with placebo (both, P < 0.05). In a Phase III, 76-week study, the rates of response, as measured using SRI, at week 52 were 42.8% and 46.5% with belimumab 1 and 10 mg/kg/dose versus 35.3% with placebo (P = NS and P < 0.001); at 76 weeks, response rates were 42.1% and 41.4% with belimumab 1 and 10 mg/kg/dose versus 33.8% with placebo (P < 0.05 and P = NS). The tolerability data from these studies did not suggest any overall differences between belimumab and placebo. CONCLUSIONS: Based on the findings from the present review, belimumab appears to be efficacious and generally well-tolerated and in the treatment of SLE other than lupus nephritis or neuropsychiatric lupus. Additional clinical and economics studies are needed to determine the most appropriate place for belimumab in the treatment of SLE.

Golimumab: Review of the efficacy and tolerability of a recently approved tumor necrosis factor-α inhibitor.

BACKGROUND: Golimumab (GLM) is a tumor necrosis factor-α (TNF-α) inhibitor that was approved in the United States in 2009 for use with methotrexate (MTX) in adults with moderate to severe active rheumatoid arthritis (RA), and with or without MTX or other non-biologic disease-modifying antirheumatic drugs in adults with active psoriatic arthritis (PsA) or active ankylosing spondylitis (AS). GLM is administered as a 50-mg subcutaneous injection once a month. OBJECTIVES: The goals of this article were to review the current literature on GLM and to provide recommendations for the use of GLM based on the published information. METHODS: The PubMed, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, International Pharmaceutical Abstracts, and other databases, as well as the Web sites for the American College of Rheumatology (ACR) and the European Union League Against Rheumatism, were searched for relevant articles published in English between the inception of the databases through April 2010. Search terms included golimumab and CNTO 148. Pharmacologic, pharmacokinetic, clinical, outcomes, and economic studies as well as meta-analyses, case reports, and select abstracts were eligible for inclusion. Review articles on GLM were not used except to identify other primary papers. RESULTS: Seven clinical studies were identified and used to evaluate the efficacy and tolerability of GLM: 5 in patients with RA (4 subcutaneous administration and 1 intravenous administration), 1 in patients with PsA (subcutaneous), and 1 in patients with AS (subcutaneous). In MTX-naive patients with RA, the number of patients satisfying the ACR20 response criteria (>20% improvement in ACR response rate) at 24 weeks was significantly higher for the GLM + MTX groups than for the MTX-only groups (62% vs 49%, respectively; P < 0.05). In patients with active RA despite MTX therapy, ACR20 responses at 14 to 16 weeks were significantly higher for the combined GLM + MTX groups than for the MTX groups (50%-79% vs 33%-37%, respectively; P < 0.001). GLM was more effective than placebo, both with and without MTX, in patients with RA and a history of treatment with 1 or 2 TNF-α inhibitors (ACR20 at 14 weeks, 35%-37% vs 18%, respectively; P < 0.001). Studies of other TNF-α inhibitors reported ACR20 responses in 53% to 59% of patients with active RA at 24 weeks. GLM was also more effective than placebo at 24 weeks in patients with PsA (ACR20, 52%-61% vs 12%, respectively; P < 0.001) (ASAS40 [40% improvement based on Assessment in Ankylosing Spondylitis International Working Group criteria], 44%-54% vs 15%, respectively; P < 0.001). Studies of other TNF-α inhibitors reported ACR20 responses at 24 weeks in 55% to 57% of patients with PsA and ASAS40 responses in 46% to 47% of patients with AS. The incidence of any adverse effect appeared to be comparable in the GLM (61.2%-93.9%) and placebo groups (59.3%-85.3%), but withdrawals because of adverse effects were higher in the GLM groups (0%-12.1%) than in the placebo groups (0%-5.9%). The incidence of serious infections was comparable for GLM (0%-4.4%) and placebo (0.8%-3.5%). The most frequently reported adverse effects in the GLM groups were injection-site reactions (2.7%-37.1%), nausea (2.7%-22.9%), headache (3.8%-21.2%), nasopharyngitis (1.9%-15.0%), and upper respiratory tract infections (5.7%-13.8%). CONCLUSIONS: Based on the results of the studies included in this review, GLM appeared to be more effective than placebo in patients with RA, PsA, or AS. Clinical studies have not directly compared GLM with other TNF-α inhibitors. However, according to the available efficacy and tolerability data, GLM should be considered as the first or second TNF-α inhibitor for the treatment of PsA or AS and as the second or possibly first TNF-α inhibitor in combination with MTX for the treatment of RA.

Preprofessional curriculum in preparation for doctor of pharmacy educational programs.

The preprofessional pharmacy curriculum provides the foundation for the professional curriculum. Basic requirements are noted in the ACPE Standards and Guidelines, but there is considerable variation in the preprofessional curriculum requirements for entry into doctor of pharmacy programs in the United States. Changes in higher education, pharmacy practice, and health care continue to drive the need to evaluate the preprofessional curriculum. The objectives of this white paper were to create model preprofessional curricula that would enable students to be successful during and after entry into the professional curriculum. Using an evidence-based approach where possible, a number of factors were found to be associated with academic success during a pharmacy program and on licensing examinations. These data and other information were used to create 2 preprofessional curricular models that include the development of general and discipline-specific abilities. Challenges remain in accurately evaluating the abilities and attributes of applicants and the impact of those abilities and attributes on their success as a student and a practitioner. Colleges and schools of pharmacy should consider adopting a more consistent preprofessional curriculum on a national level. This preprofessional curriculum should be multi-dimensional, based on needs for future practice, and revised over time.

ACCP white paper: Essential components of a faculty development program for pharmacy practice faculty.

Prospective, ongoing faculty development programs are important in the initial orientation and short- and long-term development of faculty in higher education. Pharmacy practice faculty are likely to benefit from a comprehensive faculty development program due to the complex nature of their positions, incomplete training in select areas, and multiple demands on their time. The need for faculty development programs is supported by the increased need for pharmacy practice faculty due to the increased number of colleges and schools of pharmacy, expanding enrollment in existing colleges and schools, and loss of existing senior faculty to retirement or other opportunities within or outside the academy. This White Paper describes a comprehensive faculty development program that is designed to enhance the satisfaction, retention, and productivity of new and existing pharmacy practice faculty. A comprehensive faculty development program will facilitate growth throughout a faculty member's career in pertinent areas. The structure of such a program includes an orientation program to provide an overview of responsibilities and abilities, a mentoring program to provide one-on-one guidance from a mentor, and a sustained faculty development program to provide targeted development based on individual and career needs. The content areas to be covered in each component include the institution (e.g., culture, structure, roles, responsibilities), student-related activities, teaching abilities, scholarship and research abilities, practice abilities and the practice site, and professional abilities (e.g., leadership, career planning, balancing responsibilities). A general framework for a comprehensive pharmacy practice faculty development program is provided to guide each college, school, department, and division in the design and delivery of a program that meets the needs and desires of the institution and its faculty.