Sunday, 15 January 2017

My Rheumatology Highlights 2016

My Rheumatology highlights from 2016

As we start the new year 2017, here are my rheumatology highlights from papers and abstracts in 2016. These were papers and abstracts in no particular order. I discussed these papers with colleagues at conferences, meetings and journal clubs. I hope you find them useful. 

They were many other papers but due to space and time, I have not included all of them here. 

Do share your favourite rheumatology papers from 2016 too.

Baricitinib in Patients with Refractory Rheumatoid Arthritis.
N Engl J Med. 2016 Mar 31;374(13):1243-52
Phase 3 study involving 527 patients with an inadequate response to or unacceptable side effects associated with one or more tumor necrosis factor inhibitors, other biologic DMARDs, or both, we randomly assigned the patients in a 1:1:1 ratio to baricitinib at a dose of 2 or 4 mg daily or placebo for 24 weeks. Significantly more patients receiving baricitinib at the 4 -mg dose than those receiving placebo had an ACR20 response at week 12 (55% vs. 27%, P<0.001). In patients with rheumatoid arthritis and an inadequate response to biologic DMARDs, baricitinib at a daily dose of 4 mg was associated with clinical improvement at 12 weeks.

Sifalimumab, an anti-interferon-α monoclonal antibody, in moderate to severe systemic lupus erythematosus: a randomised, double-blind, placebo-controlled study.
Ann Rheum Dis. 2016 Nov;75(11):1909-1916.
The efficacy and safety of sifalimumab were assessed in a phase IIb, randomised, double-blind, placebo-controlled studyof adults with moderate to severe active systemic lupus erythematosus (SLE). Compared with placebo, a greater percentage of patients who received sifalimumab (all dosages) met the primary end point of SLE responder index response at week 52 (placebo: 45.4%; 200 mg: 58.3%; 600 mg: 56.5%; 1200 mg 59.8%). Sifalimumab is a promising treatment for adults with SLE. Improvement was consistent across various clinical end points, including global and organ-specific measures of disease activity.

Efficacy and Safety of Switching Between Certolizumab Pegol and Adalimumab after Primary Anti-TNF Treatment Failure: 2-Year Results from a Randomized, Investigator-Blind, Superiority Head-to-Head Study

Fleischmann R et al
EXXELERATE is the first randomized controlled trial (RCT) to address immediate switching to another TNFi, in a TNFi IR patient population. EXXELERATE was a 104-wk randomized, investigator-blind, parallel-group, head-to-head superiority study comparing the early (Wk 12)- and Wk 104 efficacy and safety of certolizumab pegol (CZP)+MTX vs adalimumab (ADA)+MTX. Pts were randomized 1:1 to CZP+MTX or ADA+MTX. Clinical improvement was observed in a considerable proportion of pts; 33 pts (55.9%) switching to CZP and 40 pts (60.6%) switching to ADA responded 12 wks later (Wk 24) by achieving DAS28(ESR) ≤3.2 or a DAS28(ESR) reduction from Wk 12 of ≥1.2. EXXELERATE demonstrated that efficacy can be achieved using a second TNFi in a proven primary TNFi failure pt population.

Tapering biologic and conventional DMARD therapy in rheumatoid arthritis: current evidence and future directions.
Ann Rheum Dis. 2016 Aug;75(8):1428-37
Schett G et al
This review article discusses the current developments of DMARD tapering and provides an overview of existing studies on this topic and addresses new strategies to reach drug-free remission. Defining patients eligible for DMARD tapering are described and potential future strategies in using biomarkers in predicting the risk for disease relapse after initiation of DMARD tapering are addressed.

Efficacy and Safety of Tocilizumab in Patients with Giant Cell Arteritis: Primary and Secondary Outcomes from a Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial

Stone JH et al
The early results of GiACTA study confirm the efficacy of tocilizumab (TCZ) in giant cell arteritis. TCZ with a 26-week prednisone taper was superior to both short- and long-course prednisone tapers for the achievement of sustained remission at 52 weeks. The addition of TCZ to prednisone also led to a substantial reduction in the cumulative prednisone doses required to control GCA.

Combination Therapy of Apremilast and Biologic Agent As a Safe Option of Psoriatic Arthritis and Psoriasis

Metyas et al
Apremilast can be safely and effectively combined with biologic agents in patients with plaque psoriasis or psoriatic arthritis not responding adequately to these agents alone. No major side effects of cancer or sever infection were reported other than nausea and/or vomiting that were manageable in some patients.

No Increased Risk of Inflammatory Bowel Disease Among Secukinumab-Treated Patients with Moderate to Severe Psoriasis, Psoriatic Arthritis, or Ankylosing Spondylitis: Data from 14 Phase 2 and Phase 3 Clinical Studies

Deodhar A et al
Events of CD and UC in the 14 clinical studies were reported infrequently in secukinumab-treated pts with psoriasis, PsA, or AS; rates were similar across the psoriasis and PsA cohorts. EAIR rates of CD and UC observed in secukinumab-treated pts are consistent with those reported in the literature in psoriasis, PsA, and AS populations.

A Single Infusion of Rituximab Delays the Onset of Arthritis in Subjects at High Risk of Developing RA

Gerlag DM et al
The PRAIRI study reporting preliminary data from a randomized, blinded study of 81 participants. When given to individuals with preclinical RA (elevated antibodies to citrullinated proteins and rheumatoid factor but no synovitis on baseline examination), a single infusion of 1000 mg rituximab significantly delays the development of arthritis in subjects at risk of developing RA by about 12 months.


Cardiovascular Safety of Celecoxib, Naproxen, or Ibuprofen for Arthritis

N Engl J Med. 2016 Dec 29;375(26):2519-29
Nissen SE et al
The cardiovascular safety of celecoxib was compared with nonselective nonsteroidal antiinflammatory drugs (NSAIDs). At moderate doses, celecoxib was found to be noninferior to ibuprofen or naproxen with regard to cardiovascular safety.

Ustekinumab as Induction and Maintenance Therapy for Crohn's Disease.
N Engl J Med. 2016 Nov 17;375(20):1946-1960
Feagan BG et al.                            
Patients received a single intravenous dose of ustekinumab (either 130 mg or approximately 6 mg per kilogram of body weight) or placebo in two induction trials. The UNITI-1 trial included 741 patients who met the criteria for primary or secondary nonresponse to tumor necrosis factor (TNF) antagonists or had unacceptable side effects. The UNITI-2 trial included 628 patients in whom conventional therapy failed or unacceptable side effects occurred. Patients who completed these induction trials then participated in IM-UNITI, in which the 397 patients who had a response to ustekinumab were randomly assigned to receive subcutaneous maintenance injections of 90 mg of ustekinumab (either every 8 weeks or every 12 weeks) or placebo. Patients with moderately to severely active Crohn's disease, those receiving intravenous ustekinumab had a significantly higher rate of response than did those receiving placebo. Subcutaneous ustekinumab maintained remission in patients who had a clinical response to induction therapy.

Tumour necrosis factor inhibition versus rituximab for patients with rheumatoid arthritis who require biological treatment (ORBIT): an open-label, randomised controlled, non-inferiority, trial

Lancet2016; 388: 239-247

Porter D et al
Data from the Optimal Management of Rheumatoid Arthritis Patients Requiring Biologic Therapy (ORBIT) study showed that initial treatment with rituximab is non-inferior to initial TNF inhibitor treatment in patients seropositive for rheumatoid arthritis and naive to treatment with biologicals, and is cost saving over 12 months.

BSR and BHPR guideline on prescribing drugs in pregnancy and breastfeeding-Part I: standard and biologic disease modifying anti-rheumatic drugs and corticosteroids.

Rheumatology (Oxford). 2016 Sep;55(9):1693-7

Flint J et al

Updated guidelines on prescribing DMARDs and biologics in pregnancy and breastfeeding. A very useful resource for clinicians.



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