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Annex 8 WORKING PAPER: Elimination of leprosy as a public health problem – current status and challenges ahead Leprosy 56 Report of the Scientific Working Group on Leprosy, 2002 • TDR/SWG/02 Report of the Scientific Working Group on Leprosy, 2002 • TDR/SWG/02 57 ELIMINATION OF LEPROSY AS gy with tuberculosis, it was believed that treatment A PUBLIC HEALTH PROBLEM with regimens composed of two or more drugs, each acting by a different antimicrobial mechanism, – CURRENT STATUS AND would prevent relapse with dapsone-resistant M. CHALLENGES AHEAD leprae. The rapid bactericidal action of rifampicin raised hopes that treatment with this drug would be curative. Large-scale multicentre clinical tri- D. Daumerie als proved the high efficacy and good tolerability Communicable Diseases, of a once monthly dose of rifampicin. A major line World Health Organization, Geneva of investigation at the time was comprised of con- trolled clinical trials among patients with lepro- matous leprosy, to examine the efficacy of various combined drug regimens. The long-term follow-up A GLIMPSE AT THE HISTORY of multibacillary (MB) patients whose treatment had been terminated suggested that the risk of relapse of The first formal attempt to estimate the global lep- MB leprosy after termination of chemotherapy, espe- rosy burden was made by WHO in 1966, when the cially with multidrug therapy (MDT), was smaller caseload was estimated to be 10 786 000, of whom than had been feared. As a result, it now appeared 60% were not registered for treatment. This figure ethical for THELEP to undertake large-scale field was updated in 1972 at the marginally lower esti- trials of MDT, in which treatment was to be of finite mate of 10 407 200 cases. In 1977, the WHO Expert duration and patients with MB leprosy were to be Committee, in its fifth report, estimated the case- followed for evidence of relapse after treatment load to be over 12 million cases, and in 1983, the had been terminated. Because of its extraordinarily WHO Study Group on the Epidemiology of Leprosy potent bactericidal activity against M. leprae, rifam- in Relation to Control referred to an estimate of picin became an essential component of regimens, 11 525 000 cases. Thus 10-12 million cases was and dapsone and clofazimine were included to pre- the range frequently mentioned in the mid-1980s. vent the emergence of rifampicin-resistant M. leprae. It was obvious by the mid-1970s that the efforts In 1981, WHO convened the Study Group on to control leprosy using long duration, even life- Chemotherapy for Leprosy Control. The Study long, dapsone monotherapy were failing. This led Group recommended combined drug regimens to the establishment by WHO/TDR of research pro- based on the supervised intermittent administration grammes directed at developing an effective protec- of rifampicin for both MB and paucibacillary (PB) tive vaccine (IMMLEP) and more effective therapy leprosy. These WHO “study-group regimens” were (THELEP). Surveys showed widespread secondary then widely implemented. and primary resistance to dapsone, with the preva- lence of secondary resistance ranging from 10 to 386 per 1000 patients, and that for primary resistance as high as 550 per 1000 new patients. Using the analo- Figure 1. Global prevalence of �������������� ������������ ���� leprosy � � � � � � � � � �������� � � � � ������������� � � �� �� �� �� �� �� �� �� �� �� �� �� �� �� �� �� �� �� �� �� �� �� �� �� �� �� 58 Report of the Scientific Working Group on Leprosy, 2002 • TDR/SWG/02 Report of the Scientific Working Group on Leprosy, 2002 • TDR/SWG/02 59 Figure 2. Global detection ��� ��� � ��� � � ��� � � � ��� � � ��� � ��� ��� ��� � �� �� �� �� �� �� �� �� �� �� �� �� �� �� �� �� �� �� �� �� �� �� FROM CONTROL TO ELIMINATION areas. The result was an intensification of leprosy AS A PUBLIC HEALTH PROBLEM elimination efforts leading to a significant decline in prevalence between 1991 and 1996, before it started Due to the substantial progress in leprosy control to level off and reach the detection level (Fig 1). achieved by implementing MDT, the World Health Assembly (WHA) in 1991 called for the “elimina- In the meantime, there was a steady increase in the tion of leprosy as a public health problem by the number of new cases reported. Global detection year 2000”, defining elimination as attaining a level was first reported in 1991, with 584 000 new cases of prevalence below 1 case per 10 000 population. detected (Fig. 2). Global detection reached a peak The figures and trends at the time suggested that of 820 000 in 1998 and then levelled of at around this ambitious goal was feasible. In 1991, global esti- 750 000 during the following years. WHO attribut- mates of the leprosy burden were revised to 5.3 mil- ed this to a number of factors such as the intensified lion, from the 10-12 million of 1985. This was largely efforts of case detection, high transmission of the due to the number of patients who had been cured disease in certain areas, over-diagnosis or re-regis- and taken off the registers. It was estimated that tration of previously treated cases, and leprosy elim- about 2-3 million people had residual grade 2 defor- ination campaigns (about 50% of cases are attributed mities. to the wide-scale introduction of LECs). The elimination strategy had the effect of galvaniz- ing governments, nongovernmental funding agen- GLOBAL BURDEN OF LEPROSY cies, and communities. WHO developed the concept 1990-2000 of leprosy elimination campaigns (LECs) and spe- Table 1 summarizes global burden of leprosy esti- cial action programmes for the elimination of lepro- mates (GBD) for 1990 and 2000. sy (SAPELs) in order to detect and treat all patients, including those in difficult to access geographic Table 1. Males Females Persons Global total years YLD(‘000) of life lost due to GBD1990 171 166 337 disability (YLD), years of life lost GBD2000 58 56 114 (YLL), and disability YLL(‘000) adjusted life years GBD1990 23 21 44 (DALYs) estimates, GBD2000 19 9 27 1990 and 2000 DALY(‘000) GBD1990 194 187 381 GBD2000 77 65 141 58 Report of the Scientific Working Group on Leprosy, 2002 • TDR/SWG/02 Report of the Scientific Working Group on Leprosy, 2002 • TDR/SWG/02 59 WHAT IS THE LEPROSY • At the beginning of 2002, the number of leprosy ELIMINATION STRATEGY? patients was around 635 000, as reported by 106 countries (Table 2). About 760 000 new cases The strategy for elimination of leprosy as a public health were detected during 2001. Global detection problem is based on early case detection and cure with increased in 2001 as compared to 2000 mainly multidrug therapy. The defined target is to reduce the because of a significant increase in detection in prevalence, in any given endemic area, to less than one India. case per 10 000 population. The strategy is based on cer- • More than 12 million cases had been cured by tain assumptions which need to be understood: the beginning of 2002. • Among newly detected cases, 17% are chil- • MDT treatment, together with early case-find- dren (below the age of 15), 39% are MB based ing, is the best way available today for dealing on the clinical classification (more than five with the problem of leprosy and its conse- skin lesions), 9% are single skin lesion leprosy, quences. and 4% present grade 2 disability at the time of • The impact of MDT on the disease incidence diagnosis. will be significant only when there are no more • The number of relapses remains low, at less “hidden” cases, when MDT coverage reaches than one case per 1000 patients per year. optimal levels and is maintained for a number • No drug resistance following MDT has yet been of years. reported. • As leprosy has a long incubation period and an • The number of countries showing prevalence insidious onset, the impact on transmission will rates above 1 per 10 000 population was reduced be slow and new cases will continue to appear from 122 in 1985 to 14 at the end of 2001. for several years after elimination levels have • Fewer areas are not covered by MDT. These been reached. areas include those which are difficult to access • The new case detection figure is a poor proxy or contain refugee populations, though this indicator for incidence and it mainly reflects the remains problematic. operational performance of the programme. • The gender imbalance has decreased signifi- cantly. Where do we stand today? • An increasing number of countries request free Elimination as defined in the strategy was attained supply of MDT drugs. at global level by the end of the year 2000. However, 14 countries were not able to reach the elimination But this is not the end of the story. This was probably the target at national level. least difficult part. We are now moving to a far more chal- lenging phase. Features of the current global leprosy situation include: Leprosy situation today Leprosy by type, age, and disability status at the time of detection In 2000, 115 countries reported 675 180 new cases Table 2. with classifications (Table 3), out of which 261 713 Latest global leprosy situation as reported by (39%) were MB, 352 347 (52%) were PB, 61 091 were 106 countries single lesion (9%), and 29 were of unknown clas- sification. The proportion of MB cases is high in Region Point Cases detected the Eastern Mediterranean, Western Pacific and prevalence during the year 2001 European Regions (WHO regions), and is particu- larly low in the South-East Asian Region. Africa 45 170 39 612 Americas 83 101 42 830 Data from 81 countries that reported the proportion East Mediterranean 7 007 4 758 of children below 15 years of age among new cases South East Asia 488 333 668 658 shows that, out of 645 517 cases, 112 327 (17%) were Western Pacific 11 755 7 406 children (Table 4).